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New mRNA vaccine targets RSV in first human trial

NCT ID NCT06573281

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-stage trial is testing several doses of an experimental mRNA vaccine against RSV in 213 healthy adults aged 18-45. The goal is to check the vaccine's safety and how well it triggers an immune response. Participants receive two shots, and researchers monitor for side effects and measure antibody levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-based RSV vaccine
What this could lead to
If successful, this could lead to a new vaccine to protect against RSV, a common respiratory virus that can be serious for infants and older adults.
What could go wrong
This is an early Phase 1 trial with only 213 healthy adults, so safety and immune response are still being tested. It may not work in larger, more diverse populations or against different RSV strains.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

213 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30281, United States

  • GSK Investigational Site

    Lenexa, Kansas, 66219, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68134, United States

  • GSK Investigational Site

    Rochester, New York, 14609, United States

  • GSK Investigational Site

    Camberwell, Victoria, 3124, Australia

  • GSK Investigational Site

    Madrid, 28006, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

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