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

Phase 1

Recruiting

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: Investigational RSV vaccine 6; 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; Drug: Placebo

• Registration Number: NCT06573281
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-27
• Status Verified: 2024-09
• Study Start: 2024-09-30
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-07-02
• Study Completion: 2026-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 or 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.

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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 exclusion criteria

• Pregnant or lactating female participant.
• Female participant planning to become pregnant or planning to discontinue contraceptive precautions within 1 month following the last study intervention administration.
• Alcoholism or substance use disorder within the past 24 months.
• Any study personnel or their immediate dependents, family, or household members.
• Participants with extensive body markings or conditions in the deltoid region that may preclude accurate assessment of local reactogenicity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RSV_Group F	Investigational RSV vaccine 6	-
RSV_Group A	Investigational RSV vaccine 1	-
RSV_Group B	Investigational RSV vaccine 2	-
RSV_Group C	Investigational RSV vaccine 3	-
RSV_Group D	Investigational RSV vaccine 4	-
RSV_Group E	Investigational RSV vaccine 5	-
RSV_Group F	Placebo	-
Placebo Group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2	At Day 37
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 systemic events within 7 days post-Dose 1	From Day 1 to Day 7
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 solicited administration site events within 7 days post-Dose 2	From Day 30 to Day 36
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 with clinically significant hematological and biochemical abnormalities post-Dose 1	At Day 30
Number of participants reporting solicited systemic events within 7 days post-Dose 2	From Day 30 to Day 36
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 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 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)

Secondary Outcome Measures

Name	Time	Method
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	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)	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, Month 13, and Month 19 (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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Madrid, Spain