Last updated: 09/06/2025 12:10:20

A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years

GSK study ID
222261
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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 purpose:
Prevention
Trial design:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of participants reporting solicited administration site events within 7 days post-Dose 1

Timeframe: From Day 1 to Day 7

Number of participants reporting solicited administration site events within 7 days post-Dose 2

Timeframe: From Day 30 to Day 36

Number of participants reporting solicited systemic events within 7 days post-Dose 1

Timeframe: From Day 1 to Day 7

Number of participants reporting solicited systemic events within 7 days post-Dose 2

Timeframe: From Day 30 to Day 36

Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1

Timeframe: From Day 1 to Day 29

Number of participants reporting unsolicited AEs within 29 days post-Dose 2

Timeframe: From Day 30 to Day 58

Number of participants reporting serious adverse events (SAEs)

Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)

Number of participants reporting medically attended adverse events (MAAEs)

Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)

Number of participants reporting adverse event of special interest (AESI)

Timeframe: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)

Number of participants reporting fatal SAEs

Timeframe: From Day 1 (Dose 1) up to Month 13 (study end)

Number of participants reporting related SAEs

Timeframe: From Day 1 (Dose 1) up to Month 13 (study end)

Number of participants reporting related AESIs

Timeframe: 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

Timeframe: At Day 1

Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1

Timeframe: At Day 8

Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1

Timeframe: At Day 30

Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2

Timeframe: At Day 37

Secondary outcomes:

RSV- A neutralizing titers expressed as Geometric mean titers (GMTs)

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Interventions:
  • Biological/vaccine: Investigational RSV vaccine 1
  • Biological/vaccine: Investigational RSV vaccine 2
  • Biological/vaccine: Investigational RSV vaccine 3
  • Biological/vaccine: Investigational RSV vaccine 4
  • Biological/vaccine: Investigational RSV vaccine 5
  • Biological/vaccine: Investigational RSV vaccine 6
  • Drug: Placebo
  • Enrollment:
    213
    Primary completion date:
    2026-13-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Respiratory Syncytial Virus Infections
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2024 to April 2026
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 Years
    Accepts healthy volunteers
    Yes
    • 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.
    • Medical conditions
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lenexa, KS, United States, 66219
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28006
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28222
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Rochester, NY, United States, 14609
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Rolling Hills Estates, CA, United States, 90274
    Status
    Recruitment Complete
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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