Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus (RSV), RSV mRNA vaccine, Safety, Immunogenicity, Reactogenicity
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.
Interventions
BIOLOGICALInvestigational RSV vaccine 1
Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.
BIOLOGICALInvestigational RSV vaccine 2
Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.
BIOLOGICALInvestigational RSV vaccine 3
Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.
BIOLOGICALInvestigational RSV vaccine 4
Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.
BIOLOGICALInvestigational RSV vaccine 5
Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.
BIOLOGICALInvestigational RSV vaccine 6
Investigational RSV vaccine 6 administered intramuscularly on Day 1.
DRUGPlacebo
Placebo administered intramuscularly on Day 1 and Day 30 and for RSV\_Group F placebo administered only on Day 30.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Data will be collected in an observer-blind manner
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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\^2. * 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 * Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention administration (Day -29 to Day 1), or their planned use during the study period. * Has previously received an investigational or approved vaccine or antibody for prevention of RSV infection. * Planned administration/administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention administration, except for inactivated vaccines for influenza if they are received at least 14 days before the first dose or 14 days after the last study intervention administration. * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 13 (study end) |
| Number of participants reporting related SAEs | From Day 1 (Dose 1) up to Month 13 (study end) |
| Number of participants reporting related AESIs | 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 | At Day 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 2 | At Day 37 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. |
| 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) | Seroresponse is defined as at least a 4-fold increase compared to pre-dosing titer. |
Countries
Australia, Spain, United States
Outcome results
None listed