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Low dose Strep A Alum

Phase 1

Streptococcal Infections | Monoclonal antibody | Other |GSK plc|Last Updated: Aug 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07085702A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young AdultsPHASE1 RECRUITING 108 — — Jul 31, 2025Nov 30, 2026Aug 11, 20252 Australia
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Study Endpoints
Primary Endpoints
Number of participants with solicited administration site events
Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121

Solicited administration-site events include pain, redness, and swelling at the administration site.

Number of participants with solicited systemic events
Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121

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.

Number of participants with unsolicited adverse events (AEs)
Up to 30 days after each study intervention administration occurring at Day 1, Day 31, and Day 121

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.

Number of participants with laboratory abnormalities
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)
From Day 1 to Day 301

AESIs include potential immune-mediated disorders (pIMDs) and rheumatic carditis.

Number of participants with serious adverse events (SAEs)
From Day 1 to Day 301

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.

Number of participants with AEs leading to withdrawal from the study or to discontinuation of study vaccine
From Day 1 to Day 301
Secondary Endpoints
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
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
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
30 days after each study intervention administration (Day 31, Day 61, and Day 151) compared to before study intervention administration (Day 1)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Low dose Strep A Alum GroupEXPERIMENTALParticipants randomized to receive 3 doses of Low dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
Medium dose Strep A Alum GroupEXPERIMENTALParticipants randomized to receive 3 doses of Medium dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
High dose Strep A Alum GroupEXPERIMENTALParticipants randomized to receive 3 doses of High dose Strep A Alum vaccine on Day 1, Day 31, and Day 121.
Low dose Strep A AS37 GroupEXPERIMENTALParticipants randomized to receive 3 doses of Low dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
Medium dose Strep A AS37 GroupEXPERIMENTALParticipants randomized to receive 3 doses of Medium dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
High dose Strep A AS37 GroupEXPERIMENTALParticipants randomized to receive 3 doses of High dose Strep A AS37 vaccine on Day 1, Day 31, and Day 121.
Strep A Alum Placebo GroupPLACEBO_COMPARATORParticipants randomized to receive 3 doses of Strep A Alum Placebo on Day 1, Day 31, and Day 121.
Interventions
NameTypeDescription
Low dose Strep A AlumBIOLOGICALLow dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A AlumBIOLOGICALMedium dose Strep A Alum vaccine will be administered IM
High dose Strep A AlumBIOLOGICALHigh dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37BIOLOGICALLow dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37BIOLOGICALMedium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37BIOLOGICALHigh dose Strep A AS37 vaccine will be administered IM
Strep A Alum PlaceboDRUGStrep A Alum Placebo will be administered IM
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Eligibility Criteria
Age Range18 Years — 25 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 particip...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07085702primaryCompletionDate: changed
LOWMay 24, 2026NCT07085702studyFirstPostDate: changed