MedPath

A Study of Ad26.COV2.S in Adults (COVID-19)

Phase 1
Completed
Conditions
Covid-19 Prevention
Interventions
Biological: Placebo
Registration Number
NCT04436276
Lead Sponsor
Janssen Vaccines & Prevention B.V.
Brief Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1085
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cohort 1aAd26.COV2.SParticipants (healthy adults aged greater than or equal to (\>=)18 to less than or equal to (\<=) 55 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.
Cohort 1aPlaceboParticipants (healthy adults aged greater than or equal to (\>=)18 to less than or equal to (\<=) 55 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.
Cohort 1bAd26.COV2.SParticipants (healthy adults aged \>=18 to \<= 55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.
Cohort 1bPlaceboParticipants (healthy adults aged \>=18 to \<= 55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.
Cohort 2aAd26.COV2.SParticipants (healthy adults aged \>=18 to \<=55 years) will receive Ad26.COV2.S as single vaccination in the primary regimen or matching Placebo on Day 1, followed by booster vaccination at 6 or 12 months with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>= 6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible to receive the ad hoc booster dose will continue to receive booster vaccination.
Cohort 2aPlaceboParticipants (healthy adults aged \>=18 to \<=55 years) will receive Ad26.COV2.S as single vaccination in the primary regimen or matching Placebo on Day 1, followed by booster vaccination at 6 or 12 months with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>= 6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible to receive the ad hoc booster dose will continue to receive booster vaccination.
Cohort 2bAd26.COV2.SParticipants(healthy adults aged \>=18 to \<=55 years)will receive Ad26.COV2.S in primary regimen or matching Placebo on Day 1 and 57,followed by booster vaccination at 8 or 14 months (that is, 6 or 12 months after completion of primary regimen)with same dose or matching Placebo.At unblinding visit,post EUA,conditional licensure,or approval for single dose regimen of Ad26.COV2.S vaccine,participants initially receiving placebo will be offered to receive single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.All eligible participants who have previously received any COVID-19 vaccination(as primary regimen or additional dose)if last vaccination was \>= 6 months ago,will be offered to receive single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible for ad hoc booster dose will continue to receive booster vaccination.
Cohort 2bPlaceboParticipants(healthy adults aged \>=18 to \<=55 years)will receive Ad26.COV2.S in primary regimen or matching Placebo on Day 1 and 57,followed by booster vaccination at 8 or 14 months (that is, 6 or 12 months after completion of primary regimen)with same dose or matching Placebo.At unblinding visit,post EUA,conditional licensure,or approval for single dose regimen of Ad26.COV2.S vaccine,participants initially receiving placebo will be offered to receive single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.All eligible participants who have previously received any COVID-19 vaccination(as primary regimen or additional dose)if last vaccination was \>= 6 months ago,will be offered to receive single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible for ad hoc booster dose will continue to receive booster vaccination.
Cohort 3Ad26.COV2.SParticipants (good or stable health adults aged \>=65 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose or if they are not eligible for ad-hoc booster dose, then they will be asked to continue to be followed in this study.
Cohort 3PlaceboParticipants (good or stable health adults aged \>=65 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was \>=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose or if they are not eligible for ad-hoc booster dose, then they will be asked to continue to be followed in this study.
Primary Outcome Measures
NameTimeMethod
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days post-vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 369 up to Day 412)

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 384 up to Day 451)

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 27 days after booster vaccination 2 on Day 422 (Day 429)

Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days after Vaccination 1 on Day 1 (Day 8)

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 days after vaccination 2 on Day 57 (Day 64)

Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 17 days after booster vaccination 1 on Day 183 (Day 190)

Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 days after Vaccination 2 on Day 57 (Day 64)

Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days after vaccination 1 on Day 1 (Day 8)

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 488 up to Day 604)

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days).

Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 488 up to Day 604)

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days after Vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 17 days after booster vaccination 1 on Day 239 (Day 246)

Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 days after Vaccination 2 on Day 57 (Day 64)

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 369 up to Day 412)

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 27 days after booster vaccination 2 on Day 366 (Day 373)

Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 17 days after booster vaccination 1 on Day 239 (Day 246)

Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days after vaccination 1 on Day 1 (Day 8)

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 456 up to Day 711)

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination28 days after ad hoc booster vaccination (Day 488 up to Day 625)

Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 days after Vaccination 2 on Day 57 (Day 64)

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 17 days after booster vaccination 1 on Day 183 (Day 190)

Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 27 days after booster vaccination 2 on Day 366 (Day 373)

Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen28 days after vaccination 2 on Day 57 (Day 85)

Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen28 days after Vaccination 2 on Day 57 (Day 85)

Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 228 days after booster vaccination 2 on Day 422 (Day 450)

Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen7 days post-vaccination 1 on Day 1 (Day 8)

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 days post-vaccination 2 on Day 57 (Day 64)

Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen28 days after vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen28 days after Vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 128 days after booster vaccination 1 on Day 183 (Day 211)

Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination28 days after ad hoc booster vaccination (Day 456 up to Day 732)

Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 384 up to Day 451)

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 27 days after booster vaccination 2 on Day 422 (Day 429)

Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen7 after post-vaccination 2 on Day 57 (Day 64)

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination28 days after ad hoc booster vaccination (Day 384 up to Day 472)

Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 128 days after booster vaccination 1 on Day 239 (Day 267)

Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination28 days after ad hoc booster vaccination (Day 369 up to Day 433)

Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination7 days after ad hoc booster vaccination (Day 456 up to Day 711)

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 228 days after booster vaccination 2 on Day 366 (Day 394)

Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen28 days after vaccination 1 on Day 1 (Day 29)

Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen28 days after vaccination 2 on Day 57 (Day 85)

Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Secondary Outcome Measures
NameTimeMethod
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)Days 29, 57, 71, 85, 239, and 422

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)Days 29 and 71

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)Baseline, Days 29, 57, 85 and 422

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2)Baseline, Days 15, 29, 87, 100, 114 and 268

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+Baseline, Day 15, 29, 57, 71, 85, 239 and 422

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)Days 8, 29, 57, 64, 85, 239, 246, 267 and 422

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)Days 15, 29, 87, 100, 114 and 268

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)Days 15, 29, 87, 100, 114 and 268

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1Days 29, 57, 85 and 422

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)Days 8, 29, 183, 190, 211, 366, 373, and 394,

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)Days 29, 183, 190, 211, 366, 373 and 394

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)Days 29, 57, 71, 85, 239 and 422

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)Baseline, Days 15, 29, 57, 71, 85, 239 and 422

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)Baseline, Days 29 and 366

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+Baseline, Days 29, 57, 85 and 422

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+Baseline, Days 15, 29, 87, 100, 114 and 268

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+Baseline, Days 29 and 366

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+Baseline, Days 29 and 366

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+Baseline, Days 29, 57, 85 and 422

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+Baseline, Days 15, 29, 87, 100, 114 and 268

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+Baseline, Days 15, 29, 57, 71, 85, 239 and 422

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1Days 15, 29, 57, 71, 85, 239 and 422

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1Days 29 and 366

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1Days 15, 29, 87, 100, 114 and 268

Percentage of participant with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Trial Locations

Locations (8)

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

🇺🇸

Knoxville, Tennessee, United States

UZA-SGS

🇧🇪

Edegem, Belgium

Optimal Research

🇺🇸

Austin, Texas, United States

UZ Leuven

🇧🇪

Leuven, Belgium

Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Center for Vaccinology (CEVAC)

🇧🇪

Gent, Belgium

Clinical Pharmacology Unit

🇧🇪

Merksem, Belgium

Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)

🇧🇪

Edegem, Belgium

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Posted 8/12/2020
Updated 11/24/2021
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