A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
- Conditions
- SARS-CoV-2COVID-19
- Interventions
- Biological: CV0701 mRNA COVID-19 Vaccine (Low dose)Biological: CV0701 mRNA COVID-19 Vaccine (Medium dose)Biological: CV0701 mRNA COVID-19 Vaccine (High dose)Biological: CV0601 mRNA COVID-19 VaccineBiological: Control vaccineBiological: CV0801 mRNA COVID-19 Vaccine
- Registration Number
- NCT05960097
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.
The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.
- Detailed Description
Part A:
This Phase 2 study's Part A evaluates the safety, reactogenicity, and immunogenicity of two candidate vaccines - the bivalent CV0701 and the monovalent CV0601 - in healthy adults who have received a full primary vaccination series (with or without booster doses). By including these candidates, the study will assess whether immune interference occurs between the XY spike protein and the XX spike protein antigens in the bivalent vaccine compared with the XX spike protein antigen in the monovalent vaccine. In Part A, both CV0701 and CV0601 will be compared to the Control Vaccine (that serve as a standard of care control) using a randomized, observer-blinded design.
Part B:
The purpose of Part B is to evaluate the safety and Day 29 immunogenicity of CV0801 under three storage conditions:
* Condition 1: Baseline/control
* Condition 2: Intermediate storage
* Condition 3: Maximum storage
Condition 1 serves as the control against which the performance (safety, reactogenicity, and immunogenicity) of Conditions 2 and 3 will be compared.
mRNA vaccine stability is affected by product-specific factors (e.g., molecular weight, buffer composition, lipid nanoparticle encapsulation), manufacturing factors (such as the duration the vaccine remains in liquid form during production and handling at different temperatures), and storage conditions. The impact of these factors is based on product and process knowledge as well as clinical experience.
Through Part B of this Phase 2 study, GSK and CureVac aim to develop data on how different storage conditions affect the final attributes of the vaccine in a clinical trial setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 692
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: CV0701 mRNA COVID-19 Vaccine (Low dose) CV0701 mRNA COVID-19 Vaccine (Low dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1. Part A: CV0701 mRNA COVID-19 Vaccine (Medium dose) CV0701 mRNA COVID-19 Vaccine (Medium dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1. Part A: CV0701 mRNA COVID-19 Vaccine (High dose) CV0701 mRNA COVID-19 Vaccine (High dose) Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1. Part A: CV0601 mRNA COVID-19 vaccine CV0601 mRNA COVID-19 Vaccine Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1. Part A: Control Vaccine Control vaccine Participants received one dose of the control vaccine at Day 1. Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition) CV0801 mRNA COVID-19 Vaccine Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition. Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition) CV0801 mRNA COVID-19 Vaccine Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition. Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition) CV0801 mRNA COVID-19 Vaccine Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
- Primary Outcome Measures
Name Time Method Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein At Day 29 Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein At Day 29 Part B: Number of Participants Reporting Any Solicited Administration Site AEs Day 1 to Day 7 Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein At Day 29 Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) Day 1 to Day 7 Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Part A: Number of Participants Reporting Any Solicited Systemic AEs Day 1 to Day 7 Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Part A: Number of Participants Reporting Any Unsolicited AEs Day 1 to Day 28 An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) Day 1 to Day 181 An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement.
An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations.
AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.Part B: Number of Participants Reporting Any Solicited Systemic AEs Day 1 to Day 7 Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Part B: Number of Participants Reporting Any Unsolicited AEs Day 1 to Day 28 An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs Day 1 to Day 181
- Secondary Outcome Measures
Name Time Method Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein At Day 91 and Day 181 Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein At Day 91 and Day 181 Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein At Day 29, Day 91 and Day 181 Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein At Day 29 compared to baseline (Day 1) Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein At Day 29 compared to baseline (Day 1) Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein At Day 29 compared to baseline (Day 1) Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein At Day 29, Day 91 and Day 181 compared to baseline (Day 1) GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein At Day 29, Day 91 and Day 181 compared to baseline (Day 1) GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein At Day 29, Day 91 and Day 181 compared to baseline (Day 1) GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
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Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Camberwell, Victoria, Australia
GSK Investigational Site🇦🇺Camberwell, Victoria, Australia