Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers; Influenza Immunisation
• Interventions: Biological: Quadrivalent RIV with 2018-2019 NH H3 strain; Biological: Quadrivalent RIV with H3 strain 1; Biological: Quadrivalent RIV with H3 strain 2; Biological: Quadrivalent RIV with H3 strain 2 and adjuvant; Biological: Quadrivalent RIV with H3 strain 1 and adjuvant; Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant

• Registration Number: NCT04451954
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The primary objectives of the study are:

* To describe the safety profile of the different formulations in all participants

* To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives are:

* To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).

* To describe SN antibody responses in each group against each of the H3 antigens.

* To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.

* To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

Detailed Description

Study duration per participant is approximately 1 year

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-07-02
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2023-09-15
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 7: Quadrivalent RIV Control, without adjuvant	Quadrivalent RIV with 2018-2019 NH H3 strain	1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old
Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant	Quadrivalent RIV with H3 strain 1	1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old
Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant	Quadrivalent RIV with H3 strain 2	1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old
Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant	Quadrivalent RIV with H3 strain 2 and adjuvant	1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old
Group 5: Quadrivalent RIV Control, without adjuvant	Quadrivalent RIV with 2018-2019 NH H3 strain	1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old
Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant	Quadrivalent RIV with H3 strain 1 and adjuvant	1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old
Group 6: Quadrivalent RIV Control, with adjuvant	Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant	1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old

Primary Outcome Measures

Name	Time	Method
Number of participants with unsolicited adverse events	From Day 0 to Day 28	Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Number of participants with immediate adverse events	Within 30 minutes after vaccination	Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions	From Day 0 to Day 7	Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Number of participants with adverse events of special interest	From Day 0 to Day 365	Adverse events of special interest are collected throughout the study
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine	From Day 0 to Day 28	Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)
HAI Ab titer ≥ 40 [1/dil]	From Day 0 to Day 365	Influenza vaccine antibody titers are measured by HAI assay
Number of participants with serious adverse events	From Day 0 to Day 365	Serious adverse events are collected throughout the study
Clinical safety laboratory test results	From Day 0 to Day 7	Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine	From Day 0 to Day 365	Influenza antibody titers are measured by HAI and SN assays
2-fold and 4-fold increase in SN titers	From Day 0 to Day 28	Influenza vaccine antibody titers are measured by SN assay
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine	From Day 0 to Day 90	Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0

Secondary Outcome Measures

Name	Time	Method
HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens	Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365	Influenza vaccine antibody titers are measured by HAI and SN assays
2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens	Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365	Influenza vaccine antibody titers a are measured by SN assay
Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens	From Day 0 to Day 90	Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations	Day 0 and Day 28	Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)

Trial Locations

Locations (5)

Investigational Site Number 8400002; 🇺🇸 Melbourne, Florida, United States

Investigational Site Number 8400003; 🇺🇸 San Diego, California, United States

Investigational Site Number 8400004; 🇺🇸 Orlando, Florida, United States

Investigational Site Number 8400001; 🇺🇸 Peoria, Illinois, United States

Investigational Site Number 8400005; 🇺🇸 Rockville, Maryland, United States