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

Last updated: August 6, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

Pressure Ulcers

Treatment

Low dose Strep A Alum

Strep A Alum Placebo

Low dose Strep A AS37

Clinical Study ID

NCT07085702
217935
75A50122C00028
2-28-23
224842/Z/21/Z
  • Ages 18-25
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants, who, in the opinion of the Investigator, can and will comply with therequirements 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 participantprior to performance of any study-specific procedure.

  • Healthy participants as established by medical history, clinical examination, andlaboratory assessments.

  • Satisfies all screening requirements.

  • Male and female participants between and including 18 and 25 years of age at thetime of informed consent.

  • Female participants of nonchildbearing potential may be enrolled in the study.Nonchildbearing potential is defined as premenarche, postmenopause, or had currentbilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.

  • Female participants who are of childbearing potential may be enrolled in the studyif the participant:

  • has practiced adequate contraception for 1 month prior to study interventionadministration, and

  • has a negative pregnancy test on the day of study intervention administration,and

  • has agreed to continue adequate contraception during the entire studyintervention administration period and for 1 month after completion of thestudy intervention administration series.

  • Male participants who are sexually active with a female partner of childbearingpotential are eligible to participate if they agree to have their partner use ahighly effective method of contraception for 1 month prior to the first studyintervention administration until 1 month after completion of the study interventionadministration series.

  • Male participants must refrain from donating sperm for 1 month prior to the firststudy intervention administration until 1 month after completion of the studyintervention administration series.

  • Participants seronegative for human immunodeficiency virus (HIV), hepatitis B, andhepatitis C at Screening.

Exclusion

Exclusion Criteria:

  • History of rheumatic fever or rheumatic heart disease during the lifetime of theparticipant as confirmed during interview with the participant or as documented inmedical records.

  • Recent history of pharyngitis in the last four (4) weeks will be excluded. Theseparticipants can be rescreened once the recent pharyngitis passes the 4-weeksperiod. Participants with symptoms of acute pharyngitis at Screening will be testedwith 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 beexacerbated by any component of the study interventions.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination.

  • Hypersensitivity (e.g., allergy) to medicinal products or medical equipmentanticipated to be used in this study.

  • Clinical conditions that represents a contraindication for IM vaccination or blooddraws.

  • Any behavioral or cognitive impairment or psychiatric disease that, in the opinionof the Investigator, may interfere with the participant's ability to participate inthe study.

  • Acute disease and/or fever (defined as temperature >=38.0°C) at the time ofenrollment.

  • Any Grade >=2 and/or clinically significant hematological and/or biochemicallaboratory 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 dueto participation in the study.

  • Administration of long-acting immune-modifying drugs (e.g., infliximab) at any timeprior to the administration of the first dose of study intervention(s) or plannedadministration during the study period.

  • Prior receipt of an experimental Strep A vaccine.

  • Use of any investigational or nonregistered product (drug, vaccine, or medicaldevice) other than the study interventions during the period starting 30 days beforethe first dose of study intervention (Day -30 to Day 1), or their planned use duringthe study period.

  • Receipt of a vaccine not foreseen by the study protocol administered during theperiod starting at 21 days before the first dose of study intervention (28 daysbefore the first dose, in case of live vaccines) and ending after the last dose ofstudy intervention administration.

  • Administration of immunoglobulins and/or any blood products or plasma derivatives,or bone marrow transplantation, during the period starting 3 months beforeadministration of the first dose of study intervention(s) or planned administrationduring the study period.

  • Chronic administration (defined as >14 days in total) of immunosuppressants or otherimmune-modifying drugs during the period starting 3 months prior to the first doseof study intervention. For corticosteroids, this means prednisone equivalent >=20mg/day for adult participants. Inhaled, topical, intra-articular, and intranasalsteroids are allowed.

  • Concurrently participating in another clinical study, at any time during the studyperiod, in which the participant has been or will be exposed to an investigationalor 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 discontinuecontraceptive precautions.

  • History of or current chronic alcohol consumption and/or drug abuse.

  • Any study personnel or their immediate dependents, family, or household members.

Study Design

Total Participants: 108
Treatment Group(s): 7
Primary Treatment: Low dose Strep A Alum
Phase: 1
Study Start date:
July 31, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • GSK Investigational Site

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Camberwell, Victoria 3124
    Australia

    Active - Recruiting

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