A Phase IIa Observer-blind, Randomized, Controlled, Age-de-escalation, Single Center Interventional Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GVGH iNTS Vaccine Against S. Typhimurium and S. Enteritidis, in Adults, Children and Infants, Including Dose-finding in Infants, in Africa
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane antigens (iNTS-GMMA) candidate vaccine against S. Typhimurium and S. Enteritidis with an age de-escalation and dose escalation approach in African population, starting with adults (18-50 years of age), then on children (24-59 months of age) and finally to infants (9 months and 6 weeks of age). Infants are the target for primary vaccination from 6 weeks of age.
⁃ All participants (adults, children, infants at 9 months of age and infants at 6 weeks of age) will be enrolled in the clinical site in Ghana and must satisfy ALL the following criteria at study entry:
• Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR), 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 or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
• Healthy participants as established by medical history, clinical examination, and laboratory investigations.
• Participants satisfying screening requirements.
• Participants negative for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
⁃ Adult participants must satisfy ALL the following criteria at study entry:
• A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• Female participants of childbearing potential may be enrolled in the study if the participant:
⁃ has practiced adequate contraception for 1 month prior to study intervention administration, and:
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
⁃ The Ghana card will be used as source document to verify the ages for the adults.
⁃ Child participants must satisfy ALL the following criteria at study entry:
• A male or female between and including 24 and 59 months of age at the time of the first study intervention administration.
• Previously completed routine childhood vaccinations to the best knowledge of the participant's parent(s)/LAR's.
• Born after a gestation period of ≥37 weeks.
⁃ Infant participants must satisfy ALL the following criteria at study entry:
• A male or female 6 weeks or 9 months of age at the time of the first study intervention administration.
• Born after a gestation period of ≥37 weeks.
• Born to a mother seronegative for HIV, hepatitis B virus and hepatitis C virus.
⁃ The Road to Health Chart will be used as source document to confirm the ages for the children and infants.