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
NCT ID: NCT07085702
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
108 participants
INTERVENTIONAL
2025-07-31
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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Low dose Strep A Alum Group
Participants randomized to receive 3 doses of Low dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
Low dose Strep A Alum
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A Alum Group
Participants randomized to receive 3 doses of Medium dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
Medium dose Strep A Alum
Medium dose Strep A Alum vaccine will be administered IM
High dose Strep A Alum Group
Participants randomized to receive 3 doses of High dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
High dose Strep A Alum
High dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37 Group
Participants randomized to receive 3 doses of Low dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
Low dose Strep A AS37
Low dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37 Group
Participants randomized to receive 3 doses of Medium dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
Medium dose Strep A AS37
Medium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37 Group
Participants randomized to receive 3 doses of High dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
High dose Strep A AS37
High dose Strep A AS37 vaccine will be administered IM
Strep A Alum Placebo Group
Participants randomized to receive 3 doses of Strep A Alum Placebo on Day 1, Day 31, and Day 121.
Strep A Alum Placebo
Strep A Alum Placebo will be administered IM
Interventions
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Low dose Strep A Alum
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A Alum
Medium dose Strep A Alum vaccine will be administered IM
High dose Strep A Alum
High dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37
Low dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37
Medium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37
High dose Strep A AS37 vaccine will be administered IM
Strep A Alum Placebo
Strep A Alum Placebo will be administered IM
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
25 Years
ALL
Yes
Sponsors
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HHS/BARDA
UNKNOWN
Wellcome Trust
OTHER
DHSC/GAMRIF
UNKNOWN
Germany/BMBF
UNKNOWN
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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King C Cheung
Role: PRINCIPAL_INVESTIGATOR
Emeritus Research
Juliet Freeborn
Role: PRINCIPAL_INVESTIGATOR
Emeritus Research
Locations
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GSK Investigational Site
Botany, New South Wales, Australia
GSK Investigational Site
Camberwell, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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75A50122C00028
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
224842/Z/21/Z
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2-28-23
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
217935
Identifier Type: -
Identifier Source: org_study_id
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