A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 692
- Locations
- 1
- Primary Endpoint
- Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This is an observer-blind study.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A: 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.
Intervention: CV0701 mRNA COVID-19 Vaccine (High dose) (Biological)
Part A: CV0601 mRNA COVID-19 vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
Intervention: CV0601 mRNA COVID-19 Vaccine (Biological)
Part A: 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.
Intervention: CV0701 mRNA COVID-19 Vaccine (Low dose) (Biological)
Part A: 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.
Intervention: CV0701 mRNA COVID-19 Vaccine (Medium dose) (Biological)
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
Intervention: Control vaccine (Biological)
Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
Intervention: CV0801 mRNA COVID-19 Vaccine (Biological)
Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
Intervention: CV0801 mRNA COVID-19 Vaccine (Biological)
Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Intervention: CV0801 mRNA COVID-19 Vaccine (Biological)
Outcomes
Primary Outcomes
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Time Frame: At Day 29
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Time Frame: At Day 29
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Time Frame: 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
Time Frame: At Day 29
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 to Day 181
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))