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Also known as Low dose Strep A Alum, Low dose Strep A AS37
Strep A vaccine · 1 trial · 1 indication
Solicited administration-site events include pain, redness, and swelling at the administration site.
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.
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.
AESIs include potential immune-mediated disorders (pIMDs) and rheumatic carditis.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Low dose Strep A Alum | BIOLOGICAL | Low dose Strep A Alum vaccine will be administered intramuscularly (IM) |
| Medium dose Strep A Alum | BIOLOGICAL | Medium dose Strep A Alum vaccine will be administered IM |
| High dose Strep A Alum | BIOLOGICAL | High dose Strep A Alum vaccine will be administered IM |
| Low dose Strep A AS37 | BIOLOGICAL | Low dose Strep A AS37 vaccine will be administered IM |
| Medium dose Strep A AS37 | BIOLOGICAL | Medium dose Strep A AS37 vaccine will be administered IM |
| High dose Strep A AS37 | BIOLOGICAL | High dose Strep A AS37 vaccine will be administered IM |
| Strep A Alum Placebo | DRUG | Strep A Alum Placebo will be administered IM |
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...
It is an investigational four-component vaccine designed to prevent Streptococcal Infections. GSK plc is developing it as a low dose Strep A vaccine formulated with either aluminum hydroxide (Alum) or AS37 adjuvant. It is currently in Phase 1 clinical development and has not been approved for use.
The Strep A vaccine is being studied for the prevention of Streptococcal Infections. The Phase 1 trial enrolls healthy young adult volunteers aged 18 years and older to evaluate the vaccine's safety, reactogenicity, and immunogenicity. It is investigational and not yet available as a preventive option outside of clinical research.
GSK plc, which trades under the ticker GSK, is the developer of the Strep A vaccine. The company is running the Phase 1 study of the four-component vaccine with Alum or AS37 adjuvant in Australia. GSK holds the program as part of its infectious disease vaccine pipeline.
The Strep A vaccine is in Phase 1 clinical development. One trial is currently recruiting, and no trials have been completed. Because it remains investigational, it has not received FDA approval and is not commercially available. The Phase 1 study is designed to assess safety, reactogenicity, and immunogenicity in healthy young adults.
The Strep A vaccine is being evaluated in trial NCT07085702, titled 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. The trial is recruiting, is randomized, double-blind, and placebo-controlled, and plans to enroll 108 participants in Australia.
Yes. Low dose Strep A Alum and Low dose Strep A AS37 are alternative names for the same GSK Strep A vaccine program. They refer to the low dose formulation given with either the Alum adjuvant or the AS37 adjuvant. Both formulations are being compared in the ongoing Phase 1 trial NCT07085702.