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

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Biological: Investigational RSV vaccine 5; Biological: Investigational RSV vaccine 3; Biological: Investigational RSV vaccine 6; Biological: Investigational RSV vaccine 1; Biological: Investigational RSV vaccine 2; Drug: Placebo; Biological: Investigational RSV vaccine 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06573281

222261

2024-512846-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

213 participants in 7 patient groups, including a placebo group

RSV_Group A

Experimental group

Treatment:

Biological: Investigational RSV vaccine 1

RSV_Group B

Experimental group

Treatment:

Biological: Investigational RSV vaccine 2

RSV_Group C

Experimental group

Treatment:

Biological: Investigational RSV vaccine 3

RSV_Group D

Experimental group

Treatment:

Biological: Investigational RSV vaccine 4

RSV_Group E

Experimental group

Treatment:

Biological: Investigational RSV vaccine 5

RSV_Group F

Experimental group

Treatment:

Drug: Placebo

Biological: Investigational RSV vaccine 6

Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo