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
NCT07085702 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2025-08-11
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.
Conditions
- Streptococcal Infections
Interventions
- BIOLOGICAL
-
Low dose Strep A Alum
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
- BIOLOGICAL
-
Medium dose Strep A Alum
Medium dose Strep A Alum vaccine will be administered IM
- BIOLOGICAL
-
High dose Strep A Alum
High dose Strep A Alum vaccine will be administered IM
- BIOLOGICAL
-
Low dose Strep A AS37
Low dose Strep A AS37 vaccine will be administered IM
- BIOLOGICAL
-
Medium dose Strep A AS37
Medium dose Strep A AS37 vaccine will be administered IM
- BIOLOGICAL
-
High dose Strep A AS37
High dose Strep A AS37 vaccine will be administered IM
- DRUG
-
Strep A Alum Placebo
Strep A Alum Placebo will be administered IM
Sponsors & Collaborators
-
HHS/BARDA
collaborator UNKNOWN -
Wellcome Trust
collaborator OTHER -
DHSC/GAMRIF
collaborator UNKNOWN -
Germany/BMBF
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
King C Cheung · Emeritus Research
-
Juliet Freeborn · Emeritus Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Australia
Study Locations
More Related Trials
-
Singapore SARS-CoV-2 Human Challenge Study
NCT06654973 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
NCT07214571 ·Status: RECRUITING ·Phase: PHASE2
-
Asunercept for the Treatment of Patients With Moderate to Severe COVID-19 Disease
NCT05639192 ·Status: TERMINATED ·Phase: PHASE3
-
A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus
NCT02673476 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)
NCT04742738 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
NCT01062360 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
NCT01453400 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of AL-794 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses, and the Antiviral Activity of Multiple Doses in an Influenza Challenge Study
NCT02588521 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
NCT03880474 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of Oral BTA9881 to Treat RSV Infection
NCT00504907 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
NCT05897541 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
NCT05124210 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
NCT05633433 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Study of VIR-2482 in Healthy Volunteers
NCT04033406 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
NCT04510207 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
NCT01231620 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the PK of AL-794 Formulations in Healthy Subjects
NCT02877160 ·Status: COMPLETED ·Phase: PHASE1
-
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
NCT00895947 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years
NCT04956224 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
NCT04569383 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
NCT04590586 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19
NCT04582318 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV).
NCT05228730 ·Status: TERMINATED ·Phase: PHASE3
-
A Three-Part Study Of GSK580416 In Healthy Subjects
NCT00427141 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
NCT05596045 ·Status: WITHDRAWN ·Phase: PHASE1