Pan-Salmonella vaccine
Conditions
Interventions
Saline
GVGH quadrivalent Pan Salmonella vaccine
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. 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). 2. Written informed consent obtained from the participant prior to performance of any study-specific procedure. 3. 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. NOTE: One repeat of laboratory assessments is allowed at the discretion of the Investigator. 4. 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 (Visit 4). 5. 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. 6. Participants of childbearing potential may be enrolled in the study if the participant: • Has practiced adequate contraception 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. 7. Negative HLA-B27 testing. 8. Body mass index of 18= to =30 kg/m2 at Screening. 9. Living in the study area and plan to remain in the study area for the study duration. Docusign Envelope ID: F445C84C-DCA6-435A-9B5D-231DB898523D
Exclusion criteria
Exclusion criteria: -Prior blood-culture–confirmed S. Typhi, S. Paratyphi A, or non-typhoidal Salmonella infection within 3 years before first intervention. -History of reactions/hypersensitivity to any study intervention components. -Immunosuppressive or immunodeficient condition. -Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal dysfunction. -Recurrent or uncontrolled neurological disorders or seizures. -Clinically significant hematological and/or biochemical laboratory abnormality. -Conditions contraindicating IM injections or blood draws. -Behavioral, cognitive, or psychiatric conditions that may impair study participation. -Any other clinical condition that is severe enough or could increase participant risk. -Prior receipt of any typhoid vaccine, or investigational iNTS, S. Paratyphi A, or GMMA vaccines in the participant’s life. -Use of other investigational/non-registered products within 30 days before first dose (herbal/traditional remedies excluded). -Receipt of any non-protocol vaccine from 14 days before first dose through 30 days after last dose (except seasonal influenza or COVID-19); timelines may be adjusted for emergency public-health vaccination. -Use of long-acting immune-modifying biologics (e.g., infliximab) during the study. -Receipt of immunoglobulins, blood products, or plasma derivatives within 3 months before first dose or planned during study. -Chronic immunosuppressant or immune-modifying drug use (>14 days total within 3 months before first dose) or systemic corticosteroids =20 mg/day prednisone-equivalent disqualify (inhaled/topical steroids allowed). -Concurrent participation in another study exposing the participant to an intervention (i.e. vaccine or drug). -Pregnant or lactating women, those planning pregnancy, or planning to stop contraception. -Prior or current alcohol/drug abuse. -Any study personnel or their immediate dependents, family, or household members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and reactogenicity profile of GVGH Pan-Salmonella vaccine in healthy African adults. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety profile of GVGH Pan-Salmonella vaccine in healthy African adults.;To evaluate the immunogenicity profile of GVGH Pan-Salmonella vaccine in healthy African adults. | — |
Countries
South Africa
Contacts
Public ContactMichelle Botha
Associate Director
Outcome results
None listed