Can a new vaccine stop strep a in its tracks?
NCT ID NCT07085702
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This first-in-human trial tests a new vaccine designed to protect against Group A Streptococcus (Strep A), a bacteria that can cause sore throats, skin infections, and more serious illnesses. Healthy adults aged 18 to 25 will receive one of two vaccine formulations, each with a different adjuvant (alum or AS37), at low, medium, or high doses. The study aims to see if the vaccine is safe, causes any immediate reactions, and triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A 4-component vaccine against Group A Streptococcus (Strep A), formulated with either alum or AS37 adjuvant, given in low, medium, or high doses.
- What this could lead to
- If successful, this could lead to a vaccine that prevents Strep A infections, potentially reducing serious complications like rheumatic heart disease.
- What could go wrong
- This is an early-phase trial, so the vaccine may not be safe or effective in humans. Side effects like pain, fever, or fatigue are possible.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 electronic diaries \[eDiaries\], return for follow-up visits). * Written or witnessed/thumb-printed 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 assessments. * Satisfies all screening requirements. * Male and female participants between and including 18 and 25 years of age at the time of informed consent. * Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as premenarche, postmenopause, or had current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy. * Female participants who are of childbearing potential may be enrolled in the study if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire study intervention administration period and for 1 month after completion of the study intervention administration series. * Male participants who are sexually active with a female partner of childbearing potential are eligible to participate if they agree to have their partner use a highly effective method of contraception for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series. * Male participants must refrain from donating sperm for 1 month prior to the first study intervention administration until 1 month after completion of the study intervention administration series. * Participants seronegative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C at Screening. Exclusion Criteria: * History of rheumatic fever or rheumatic heart disease during the lifetime of the participant as confirmed during interview with the participant or as documented in medical records. * Recent history of pharyngitis in the last four (4) weeks will be excluded. These participants can be rescreened once the recent pharyngitis passes the 4-weeks period. Participants with symptoms of acute pharyngitis at Screening will be tested with a Strep A rapid antigen test. Those with positive results will be excluded. * Progressive, unstable, or uncontrolled clinical conditions. * History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Hypersensitivity (e.g., allergy) to medicinal products or medical equipment anticipated to be used in this study. * Clinical conditions that represents a contraindication for IM vaccination or blood draws. * Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study. * Acute disease and/or fever (defined as temperature \>=38.0°C) at the time of enrollment. * Any Grade \>=2 and/or clinically significant hematological and/or biochemical laboratory abnormality. * Any echocardiographic/Doppler Echo findings consistent with carditis at Screening. * Recurrent history or uncontrolled neurological disorders or seizures. * Medical history or family history of autoimmune disease and other pIMDs. * Family history of acute rheumatic fever. * Acute or chronic illness, or clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality. * Any other clinical condition that might pose additional risk to the participant due to participation in the study. * Administration of long-acting immune-modifying drugs (e.g., infliximab) at any time prior to the administration of the first dose of study intervention(s) or planned administration during the study period. * Prior receipt of an experimental Strep A vaccine. * Use of any investigational or nonregistered product (drug, vaccine, or medical device) other than the study interventions during the period starting 30 days before the first dose of study intervention (Day -30 to Day 1), or their planned use during the study period. * Receipt of a vaccine not foreseen by the study protocol administered during the period starting at 21 days before the first dose of study intervention (28 days before the first dose, in case of live vaccines) and ending after the last dose of study intervention administration. * Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before administration of the first dose of study intervention(s) or planned administration during the study period. * Chronic administration (defined as \>14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first dose of study intervention. For corticosteroids, this means prednisone equivalent \>=20 mg/day for adult participants. Inhaled, topical, intra-articular, and intranasal steroids are allowed. * 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, vaccine, or invasive medical device). * Pregnant or lactating female participant. * Participant who is planning to become pregnant or planning to discontinue contraceptive precautions. * History of or current chronic alcohol consumption and/or drug abuse. * Any study personnel or their immediate dependents, family, or household members.
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGBotany, New South Wales, 2019, Australia
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GSK Investigational Site
RECRUITINGCamberwell, Victoria, 3124, Australia
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