A Phase 1, Randomized, Controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults 18 to 45 Years of Age in Africa
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\*.
• \*Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, and human immunodeficiency virus (HIV) antibodies will also be tested at Screening.
• 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.
• Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or menopause.
• Participants of childbearing potential may be enrolled in the study if the participant:
‣ Has practiced adequate contraception (as indicated in Section 10.5) for at least 30 days prior to study intervention administration, and
⁃ Has a negative pregnancy test within 24 hours prior to the study intervention administration, and
⁃ Has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series.
• Negative HLA-B27 testing.
• Body mass index of 18\>= to \<=30 kg/m2 at Screening.
• Living in the study area and plan to remain in the study area for the study duration.