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.
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 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.
History of rheumatic fever or rheumatic heart disease during the lifetime of the participant as confirmed during interview with the participant or as documented in medical records.
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.
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Treatment groupsSee each treatment group below.
GlaxoSmithKline
Lead sponsor
HHS/BARDA
Collaborator
Wellcome Trust
Collaborator
DHSC/GAMRIF
Collaborator
Germany/BMBF
Collaborator