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

NCT06573281 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2222612024-512846-41
• Study Type: interventional
• Target: 213
• Locations: 3 countries
• Sites: 9

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus (RSV); RSV mRNA vaccine; Safety; Immunogenicity; Reactogenicity

Outcome Measures

Primary Outcomes (16)

• 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 1

  At Day 30

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

  At Day 37

Secondary Outcomes (6)

• 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)

Study Arms (7)

RSV_Group A

EXPERIMENTAL

Biological: Investigational RSV vaccine 1

RSV_Group B

EXPERIMENTAL

Biological: Investigational RSV vaccine 2

RSV_Group C

EXPERIMENTAL

Biological: Investigational RSV vaccine 3

RSV_Group D

EXPERIMENTAL

Biological: Investigational RSV vaccine 4

RSV_Group E

EXPERIMENTAL

Biological: Investigational RSV vaccine 5

RSV_Group F

EXPERIMENTAL

Biological: Investigational RSV vaccine 6; Drug: Placebo

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Investigational RSV vaccine 1 BIOLOGICAL

Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.

RSV_Group A

Investigational RSV vaccine 2 BIOLOGICAL

Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.

RSV_Group B

Investigational RSV vaccine 3 BIOLOGICAL

Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.

RSV_Group C

Investigational RSV vaccine 4 BIOLOGICAL

Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.

RSV_Group D

Investigational RSV vaccine 5 BIOLOGICAL

Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.

RSV_Group E

Investigational RSV vaccine 6 BIOLOGICAL

Investigational RSV vaccine 6 administered intramuscularly on Day 1.

RSV_Group F

Placebo DRUG

Placebo administered intramuscularly on Day 1 and Day 30 and for RSV\_Group F placebo administered only on Day 30.

Placebo Group; RSV_Group F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30281, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Camberwell, Victoria, 3124, Australia

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: September 30, 2024
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

ES (3); AU (1); US (5)