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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Hollywood, Florida, United States
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: 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)
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.
Time frame: Day 1 to Day 7
Part A: Number of Participants Reporting Any Solicited Systemic AEs
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.
Time frame: Day 1 to Day 7
Part A: Number of Participants Reporting Any Unsolicited AEs
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.
Time frame: Day 1 to Day 28
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
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TRIPLE
Enrollment
692
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
Study vaccine was administered as a single intramuscular injection.
GSK Investigational Site
Peoria, Illinois, United States
GSK Investigational Site
Bruce, Australian Capital Territory, Australia
GSK Investigational Site
Blacktown, New South Wales, Australia
GSK Investigational Site
Botany, New South Wales, Australia
GSK Investigational Site
Brookvale, New South Wales, Australia
GSK Investigational Site
Coffs Harbour, New South Wales, Australia
GSK Investigational Site
Darlinghurst, New South Wales, Australia
GSK Investigational Site
Kanwal, New South Wales, Australia
...and 7 more locations
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.
Time frame: Day 1 to Day 181
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
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.
Time frame: Day 1 to Day 7
Part B: Number of Participants Reporting Any Solicited Systemic AEs
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.
Time frame: Day 1 to Day 7
Part B: Number of Participants Reporting Any Unsolicited AEs
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.
Time frame: Day 1 to Day 28
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
Time frame: Day 1 to Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Time frame: At Day 91 and Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Time frame: At Day 91 and Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: 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
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: 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
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At Day 29, Day 91 and Day 181 compared to baseline (Day 1)