Streptococcal InfectionsPhase 1NCT07085702

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults

A Phase 1 study testing Low dose Strep A Alum, Medium dose Strep A Alum and High dose Strep A Alum in people with Streptococcal Infections, run by GlaxoSmithKline at 2 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Streptococcal Infections
What is being tested?: Low dose Strep A Alum, Medium dose Strep A Alum and High dose Strep A Alum
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 2 sitesAustralia
Study dates: 29 Jul 2025to 29 Jun 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Australia2 sites, 2 recruiting

GSK Investigational Site
Botany, New South Wales, 2019
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting
GSK Investigational Site
Camberwell, Victoria, 3124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Recruiting

Other trials in Australia

About this study

Official title: A Phase 1 Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Vaccine Against Group A Streptococcus Pyogenes (Strep A) With Alum or AS37 in Healthy Adults 18 to 25 Years of Age in Australia

The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.

Conditions: Streptococcal Infections
Being tested: Low dose Strep A Alum, Medium dose Strep A Alum, High dose Strep A Alum, Low dose Strep A AS37, Medium dose Strep A AS37
Keywords: Strep A, Streptococcus pyogenes, Safety, Reactogenicity, Immunogenicity, Healthy Adults, Australia
Medical subject headings: Streptococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low dose Strep A AlumBiological
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A AlumBiological
Medium dose Strep A Alum vaccine will be administered IM
High dose Strep A AlumBiological
High dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37Biological
Low dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37Biological
Medium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37Biological
High dose Strep A AS37 vaccine will be administered IM
Strep A Alum PlaceboDrug
Strep A Alum Placebo will be administered IM

Study groups in NCT07085702
Study group	Role	What they receive
Low dose Strep A Alum Group	Experimental	Participants randomized to receive 3 doses of Low dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. Receives: Biological: Low dose Strep A Alum
Medium dose Strep A Alum Group	Experimental	Participants randomized to receive 3 doses of Medium dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. Receives: Biological: Medium dose Strep A Alum
High dose Strep A Alum Group	Experimental	Participants randomized to receive 3 doses of High dose Strep A Alum vaccine on Day 1, Day 31, and Day 121. Receives: Biological: High dose Strep A Alum
Low dose Strep A AS37 Group	Experimental	Participants randomized to receive 3 doses of Low dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. Receives: Biological: Low dose Strep A AS37
Medium dose Strep A AS37 Group	Experimental	Participants randomized to receive 3 doses of Medium dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. Receives: Biological: Medium dose Strep A AS37
High dose Strep A AS37 Group	Experimental	Participants randomized to receive 3 doses of High dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121. Receives: Biological: High dose Strep A AS37
Strep A Alum Placebo Group	Placebo comparator	Participants randomized to receive 3 doses of Strep A Alum Placebo on Day 1, Day 31, and Day 121. Receives: Drug: Strep A Alum Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with solicited administration site events
Solicited administration-site events include pain, redness, and swelling at the administration site.
Measured: Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with solicited systemic events
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature equal to or above 38.0°C. The preferred location for measuring temperature is the axilla.
Measured: Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with unsolicited adverse events (AEs)
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
Measured: Up to 30 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with laboratory abnormalities
Measured: 7 days after each study intervention administration at Day 8, Day 38, and Day 128
Number of participants with adverse events of special interest (AESIs)
AESIs include potential immune-mediated disorders (pIMDs) and rheumatic carditis.
Measured: From Day 1 to Day 301
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity, abnormal pregnancy outcomes, or other medically significant events.
Measured: From Day 1 to Day 301
Number of participants with AEs leading to withdrawal from the study or to discontinuation of study vaccine
Measured: From Day 1 to Day 301

Secondary outcomes (3)

Geometric mean concentrations of immunoglobulin G (IgG) against Streptolysin O (SLO), S. pyogenes Cell Envelope Protease (SpyCEP), S. pyogenes Adhesion and Division protein (SpyAD), and Group A Carbohydrate (GAC), as measured by multiplex immunoassay
Measured: Before each study intervention (Day 1, Day 31, and Day 121), 30 days after each study intervention (Day 31, Day 61, and Day 151), and 7 days and 6 months after the third study intervention administration (Days 128 and 301, respectively)
Geometric mean fold increase of IgG against SLO, SpyCEP, SpyAD, and GAC, as measured by multiplex immunoassay
Measured: 30 days after each study intervention administration compared to before each study intervention administration (Day 31 versus Day 1, Day 61 versus Day 31, and Day 151 versus Day 121) and to before study intervention administration (Day 1)
Number of participants with greater than or equal to (>=) 2-fold and >=4 fold increase in IgG antibody concentration against SLO, SpyCEP, SpyAD, and GAC, as measured by multiplex immunoassay
Measured: 30 days after each study intervention administration (Day 31, Day 61, and Day 151) compared to before study intervention administration (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202529 Jun 2027

First posted25 Jul 2025
Study start29 Jul 2025
Primary completion29 Jun 2027 (estimated)
Study completion29 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Streptococcal InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07085702
Sponsor's protocol ID: 217935
Status last verified: Aug 2026
First submitted: 11 Jul 2025
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Interested in taking part?

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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