NCT06213506

A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 516 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The study will be conducted in two stages: Stage 1: Age De-escalation from Adults to Children and Infants * Adult participants will receive either iNTS-GMMA Dose C (high) or a control vaccine intramuscularly on Day 1 and Day 57. * Child participants will receive either Dose B (medium) or Dose C (high) of the candidate vaccine or the control on Day 1 and Day 57. * Infant participants (9 months of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85, and Day 169. * Infant participants (6 weeks of age) will receive either Dose A (low), Dose B (medium), or Dose C (high) of the candidate vaccine or the control on Day 1, Day 85 (Priming phase), and Day 232 (Booster phase). Stage 2: Dose-finding in Infants of 6 weeks of age -Infants (6 weeks of age) will receive one of the three dose levels (Dose A \[low\], Dose B \[medium\], or Dose C \[high\]) of the candidate vaccine or the control on Day 1, Day 85 (Priming phase), and Day 232 (Booster phase).

Conditions

• Salmonella Infections

Interventions

Type	Name	Description
BIOLOGICAL	Measles and Rubella vaccine	Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants\_9M\_Dose A, Infants\_9M\_Control A, Infants\_9M\_Dose B, Infants\_9M\_Control B, Infants\_9M\_Dose C and Infants\_9M\_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants\_6W\_Dose A, Infants\_6W\_Control A, Infants\_6W\_Dose B, Infants\_6W\_Control B, Infants\_6W\_Dose C and Infants\_6W\_Control C groups. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
BIOLOGICAL	Yellow Fever vaccine	Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants\_9M\_Dose A, Infants\_9M\_Control A, Infants\_9M\_Dose B, Infants\_9M\_Control B, Infants\_9M\_Dose C and Infants\_9M\_Control C groups. - at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants\_6W\_Dose A, Infants\_6W\_Control A, Infants\_6W\_Dose B, Infants\_6W\_Control B, Infants\_6W\_Dose C and Infants\_6W\_Control C groups. - at Day 232, concomitantly during the last study intervention administration to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
BIOLOGICAL	Pentavalent vaccine	Pentavalent vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
BIOLOGICAL	Pneumococcal vaccine	Pneumococcal vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
BIOLOGICAL	Inactivated polio vaccine	Inactivated polio vaccine is administered, as part of an Expanded Program on Immunization (EPI) vaccination, at the local EPI vaccination centers, and not part of the current clinical trial, at 6, 10 and 14 weeks of age to infants in Infants\_6W\_Dose A\_2, Infants\_6W\_Dose B\_2, Infants\_6W\_Dose C\_2 and Infants\_6W\_Control\_2 groups.
BIOLOGICAL	iNTS-GMMA Dose C	-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults\_Dose C and Children\_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose C group, and at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Dose C and Infants\_6W\_Dose C\_2 groups.
BIOLOGICAL	iNTS-GMMA Dose B	-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children\_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose B group, and at Day 1, Day 57 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose B and Infants\_6W\_Dose B\_2 groups.
BIOLOGICAL	iNTS-GMMA Dose A	3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants\_9M\_Dose A group, and at Day 1, Day 57 (during the Priming phase) and Day at 232 (during the Booster phase) to infants in the Infants\_6W\_Dose A and Infants\_6W\_Dose A\_2 groups.
BIOLOGICAL	MenACWY	-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults\_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children\_Control B and Children\_Control C groups, and at Day 1 and Day 85 to infants in the Infants\_9M\_Control A, Infants\_9M\_Control B and Infants\_9M\_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 (during the Priming phase) and at Day 232 (during the Booster phase) to infants in the Infants\_6W\_Control A, Infants\_6W\_Control B, Infants\_6W\_Control C and Infants\_6W\_Control\_2 groups. A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
COMBINATION_PRODUCT	DTPa-HBV-IPV+Hib	1 dose of DTPa-HBV-IPV+Hib vaccine administered intramuscularly at Day 169 to infants in the Infants\_9M\_Control A, Infants\_9M\_Control B and Infants\_9M\_Control C groups.
DRUG	Placebo	1 dose of Placebo administered intramuscularly at Day 57 to adults in the Adults\_Control group.

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-04-27
• Completion: 2026-04-27
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: Ghana