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.
Sequential
Low dose Strep A Alum
Biological/VaccineLow dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A Alum
Biological/VaccineMedium dose Strep A Alum vaccine will be administered IM
High dose Strep A Alum
Biological/VaccineHigh dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37
Biological/VaccineLow dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37
Biological/VaccineMedium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37
Biological/VaccineHigh dose Strep A AS37 vaccine will be administered IM
Strep A Alum Placebo
DrugStrep A Alum Placebo will be administered IM
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Treatment groupsSee each treatment group below.
Number of participants with solicited administration site events
Solicited administration-site events include pain, redness, and swelling at the administration site.
Number of participants with solicited systemic events
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)
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
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
Geometric mean fold increase of IgG against SLO, SpyCEP, SpyAD, and GAC, as measured by multiplex immunoassay
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
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GlaxoSmithKline
Lead sponsor
HHS/BARDA
Collaborator
Wellcome Trust
Collaborator
DHSC/GAMRIF
Collaborator
Germany/BMBF
Collaborator
DG HERA (kfW)
Collaborator
