A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age
Overview
- Phase
- Phase 1
- Intervention
- Investigational RSV vaccine 6
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 213
- Locations
- 1
- Primary Endpoint
- Number of participants reporting solicited systemic events within 7 days post-Dose 1
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
- •Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- •Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
- •Male or female between and including 18 and 45 years of age at the time of enrollment into the study.
- •Body mass index more than or equal to (\>=) 18 kg/m\^2 and less than (\<) 40 kg/m\^
- •Female participants of non-childbearing potential may be enrolled in the study.
- •Female participants of childbearing potential may be enrolled in the study if the participant:
- •has practiced adequate contraception for 1 month prior to study intervention administration period, and
- •has a negative pregnancy test (on urine sample) on the day of study intervention administration, and
- •has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.
Exclusion Criteria
- •Medical conditions
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Hypersensitivity to latex.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- •Recurrent history or uncontrolled neurological disorders or seizures.
- •Documented HIV, HBV, or HCV-positive participant.
- •Lymphoproliferative disorder or malignancy within 5 years before the first dose of study intervention administration.
- •History of or current suspicion of myocarditis or pericarditis.
- •Prior/Concomitant therapy
Arms & Interventions
RSV_Group F
Intervention: Investigational RSV vaccine 6
RSV_Group F
Intervention: Placebo
Placebo Group
Intervention: Placebo
RSV_Group B
Intervention: Investigational RSV vaccine 2
RSV_Group C
Intervention: Investigational RSV vaccine 3
RSV_Group D
Intervention: Investigational RSV vaccine 4
RSV_Group E
Intervention: Investigational RSV vaccine 5
RSV_Group A
Intervention: Investigational RSV vaccine 1
Outcomes
Primary Outcomes
Number of participants reporting solicited systemic events within 7 days post-Dose 1
Time Frame: From Day 1 to Day 7
Number of participants reporting solicited administration site events within 7 days post-Dose 2
Time Frame: From Day 30 to Day 36
Number of participants reporting solicited administration site events within 7 days post-Dose 1
Time Frame: From Day 1 to Day 7
Number of participants reporting solicited systemic events within 7 days post-Dose 2
Time Frame: From Day 30 to Day 36
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
Time Frame: From Day 1 to Day 29
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
Time Frame: From Day 30 to Day 58
Number of participants reporting serious adverse events (SAEs)
Time Frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting medically attended adverse events (MAAEs)
Time Frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting adverse event of special interest (AESI)
Time Frame: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting fatal SAEs
Time Frame: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related SAEs
Time Frame: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related AESIs
Time Frame: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1
Time Frame: At Day 1
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
Time Frame: At Day 30
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2
Time Frame: At Day 37
Secondary Outcomes
- 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 and Month 13 (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 and Month 13 (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 and Month 13 (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 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))
- Number of participants with seroresponse in terms of neutralizing titer against RSV-A(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))
- Number of participants with seroresponse in terms of neutralizing titer against RSV-B(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))