A Study on the Safety of and Immune Response to Different Doses of an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
NCT Number: NCT06573281
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Interventions: BIOLOGICAL: Investigational RSV vaccine 1|BIOLOGICAL: Investigational RSV vaccine 2|BIOLOGICAL: Investigational RSV vaccine 3|BIOLOGICAL: Investigational RSV vaccine 4|BIOLOGICAL: Investigational RSV vaccine 5|BIOLOGICAL: Investigational RSV vaccine 6|DRUG: Placebo
Sponsor: GlaxoSmithKline
Sex: ALL
Age: ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-03
Completion Date: 2026-06-08
Locations: GSK Investigational Site, Rolling Hills Estates, California, 90274, United States|GSK Investigational Site, Atlanta, Georgia, 30281, United States|GSK Investigational Site, Lenexa, Kansas, 66219, United States|GSK Investigational Site, Omaha, Nebraska, 68134, United States|GSK Investigational Site, Rochester, New York, 14609, United States|GSK Investigational Site, Austin, Texas, 78705, United States|GSK Investigational Site, Camberwell, 3124, Australia|GSK Investigational Site, Madrid, 28006, Spain|GSK Investigational Site, Madrid, 28046, Spain|GSK Investigational Site, Madrid, 28222, Spain

Summary:
The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.

Primary Outcome Measures: Number of participants reporting solicited administration site events within 7 days post-dose 1, From Day 1 to Day 7|Number of participants reporting solicited administration site events within 7 days post-Dose 2, From Day 30 to Day 36|Number of participants reporting solicited systemic events within 7 days post-Dose 1, From Day 1 to Day 7|Number of participants reporting solicited systemic events within 7 days post-Dose 2, From Day 30 to Day 36|Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1, From Day 1 to Day 29|Number of participants reporting unsolicited AEs within 29 days post-Dose 2, From Day 30 to Day 58|Number of participants reporting serious adverse events (SAEs), From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)|Number of participants reporting medically attended adverse events (MAAEs), From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)|Number of participants reporting adverse event of special interest (AESI), From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)|Number of participants reporting fatal SAEs, From Day 1 (Dose 1) up to Month 19 (study end)|Number of participants reporting related SAEs, From Day 1 (Dose 1) up to Month 19 (study end)|Number of participants reporting related AESIs, From Day 1 (Dose 1) up to Month 19 (study end)|Number of participants with clinically significant hematological and biochemical abnormalities at pre-study intervention administration, At Day 1 (pre-Dose 1)|Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1, At Day 8|Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1, At Day 30|Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2, At Day 37
Secondary Outcome Measures: RSV- A neutralizing titers expressed as Geometric mean titers (GMTs), At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2)|RSV- B neutralizing titers expressed as GMTs, At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2)|Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline, Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)|Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline, Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)|Number of participants with seroresponse in terms of neutralizing titer against RSV-A, Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer., Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)|Number of participants with seroresponse in terms of neutralizing titer against RSV-B, Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer., Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7, Month 13, and Month 19 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1)