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Could one shot stop RSV and hMPV? GSK begins human trials

NCT ID NCT07628049

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests an experimental vaccine from GSK that targets two respiratory viruses: RSV and hMPV. About 1,800 adults aged 18-80 will receive different doses to check safety and immune response. The goal is to see if a single shot can protect against both viruses, which can cause serious lung infections in older adults.

What this could mean

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

Active substance
RSV/hMPV combination vaccine
What this could lead to
If successful, this could lead to a single vaccine protecting against two common respiratory viruses, reducing severe illness in older adults.
What could go wrong
This is an early phase 1/2 trial focused on safety and immune response, not yet proven to prevent infection. The vaccine may not work as hoped or could cause side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 1,456 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

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 80 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 are eligible to be included in the study only if all of the following criteria apply: * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications). * Body Mass Index (BMI) between 18 kg/m\^2 and 33 kg/m\^2, inclusive. Specific inclusion criteria for OA * A male or female between and including, 60 to 80 YOA at the time of the study intervention administration. * Healthy participants or medically stable patients as established by medical history and physical examination. Specific inclusion criteria for YA * A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration. * Healthy participants as established by medical history, clinical examination and laboratory assessment at screening. * Participants of non-childbearing potential may be enrolled in the clinical study. * Participant of childbearing potential may be enrolled in the study if the participant: * has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration. * has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1. Exclusion criteria: Participants are excluded from participating in the study if any of the following criteria apply: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any medical condition that in the judgment of the investigator would make IM injection unsafe. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required). * Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history. * Documented history of HIV, HBV, HCV infection. * History of RSV and /or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months. * Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS). * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). * 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 study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period. * Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and/or RSV-associated diseases. * 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. * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone equivalent \>=20 mg/day for adult participants. Inhaled, topical and intra-articular steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives. * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. * 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. * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. * Participation of any study personnel or their immediate dependents, family, or household members. * Planned move during the study period that will prohibit participating in the study until study end. * Bedridden participants. Specific exclusion criteria for OA population * Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration. * At screening (Phase 1 only), participants with: * \>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded: * Hematologic: hemoglobin (Hb), white blood cells (WBC), platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils, * Biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, creatinine, blood urea nitrogen (BUN). * Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included. Specific exclusion criteria for YA population * Pregnant or lactating participant. * Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration. * Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration. * At screening, participants with: * \>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded: * Hematologic: Hb, WBC, platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils, * Biochemical: ALT, AST, ALP, bilirubin, creatinine, BUN. * Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included. * Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and/or planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Lenexa, Kansas, 66219, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    RECRUITING

    Botany, New South Wales, 2019, Australia

  • GSK Investigational Site

    RECRUITING

    Camberwell, Victoria, 3124, Australia