A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
Phase 2
Active, not recruiting
- Conditions
- SARS-CoV-2
- Interventions
- Biological: CV0701 Bivalent High doseBiological: CV0701 Bivalent Medium doseBiological: CV0701 Bivalent Low doseBiological: Control vaccineBiological: CV0801 MonovalentBiological: CV0601 Monovalent High dose
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 675
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A, Group A: CV0701 High dose CV0701 Bivalent High dose Participants receive high dose of CV0701. Part A, Group B: CV0701 Medium dose CV0701 Bivalent Medium dose Participants receive medium dose of CV0701. Part A, Group C: CV0701 Low dose CV0701 Bivalent Low dose Participants receive low dose of CV0701. Part A, Group E: Control vaccine Control vaccine Participants receive control vaccine. Part B, Condition 2: Intermediate storage CV0801 Monovalent Participants receive one dose of CV0801. Part B, Condition 3: Maximum storage conditions CV0801 Monovalent Participants receive one dose of CV0801. Part A, Group D: CV0601 High dose CV0601 Monovalent High dose Participants receive high dose of CV0601. Part B, Condition 1: Baseline-control CV0801 Monovalent Participants receive one dose of CV0801.
- Primary Outcome Measures
Name Time Method Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein Day 29 Part A: Percentage of participants with serious adverse events (SAEs) Day 1 through End of Study (approximately 180 days after the study intervention administration) Part B: Percentage of participants with adverse events of special interest (AESIs) Part B: Percentage of participants with adverse events of special interest (AESIs) Day 1 through End of Study (approximately 180 days after the study intervention administration) Part A: Percentage of participants with solicited administration site adverse events (AEs) Day 1 to Day 7 Part A: Percentage of participants with solicited administration systemic AEs Day 1 to Day 7 Part B: Percentage of participants with solicited administration systemic AEs Day 1 to Day 7 Part B: Percentage of participants with serious adverse events (SAEs) Day 1 through End of Study (approximately 180 days after the study intervention administration) Part B: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein Day 29 Part A: Percentage of participants with unsolicited AEs Day 1 to Day 28 Part A: Percentage of participants with medically attended adverse events (MAAEs) Day 1 through End of Study (approximately 180 days after the study intervention administration) Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein Day 29 Part B: Percentage of participants with unsolicited AEs Day 1 to Day 28 Part A: Percentage of participants with adverse events of special interest (AESIs) Day 1 through End of Study (approximately 180 days after the study intervention administration) Part B: Percentage of participants with solicited administration site adverse events (AEs) Day 1 to Day 7 Part B: Percentage of participants with medically attended adverse events (MAAEs) Day 1 through End of Study (approximately 180 days after the study intervention administration)
- Secondary Outcome Measures
Name Time Method Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein Days 29, 91 and 181 Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein Days 29, 91 and 181 Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein Days 29, 91 and 181 Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein Days 29, 91 and 181 Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein Day 91 and Day 181 Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein Day 91 and Day 181 Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein Day 29 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 from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein Day 29 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 from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein Day 29 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Tarragindi, Australia