The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.
Participants who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the Diary cards, return for follow-up visits).
Written 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 assessment*.
A male or female between and including 18 to 45 years of age at the time of the first study intervention administration, and no older than 45 years of age at second dose administration.
Known exposure to S. Typhi, S. Paratyphi A, and non-typhoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration as confirmed using medical history.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Sequential
Pan-Salmonella-with-Alum (Low dose) vaccine
Biological/VaccineParticipants receive low dose of the Pan-Salmonella-with-Alum.
Pan-Salmonella-with-Alum (Full dose) vaccine
Biological/VaccineParticipants receive full dose of the Pan-Salmonella-with-Alum.
Pan-Salmonella-without-Alum (Low dose) vaccine
Biological/VaccineParticipants receive low dose of the Pan-Salmonella-without-Alum.
Pan-Salmonella-without-Alum (Full dose) vaccine
Biological/VaccineParticipants receive full dose of the Pan-Salmonella-without-Alum.
Typhoid Vi conjugate vaccine
Biological/VaccineParticipants receive Typhoid Vi conjugate vaccine as control
Placebo
Other interventionParticipants receive Placebo (saline solution) as control.
Number of participants with solicited administration site events
Assessed solicited administration site events will be pain, redness and swelling.
Number of participants with solicited administration site events
Number of participants with solicited administration site events
Number of participants with solicited systemic events
Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue.
Number of participants with serious adverse events (SAEs)
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention
Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody
The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA).
Adjusted GMC of anti-serotype specific IgG antibody
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