A Phase 1/2a, Observer-blind, Randomized, Controlled, Two-stage, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Response of the Trivalent Vaccine Against Invasive Nontyphoidal Salmonella (iNTS) and Typhoid Fever in Healthy European and African Adults

Status: Completed
Location: See all (2) locations...
Intervention Type: Biological, Combination product, Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.

• Written or witnessed/thumb printed 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.

• Participant satisfying screening requirements.

• 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 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 post-menopause.

• Female participants of childbearing potential may be enrolled in the trial 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.

• Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range.

• Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study\*.

⁃ Only for Stage 1.

• For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration.

Locations
Other Locations
Belgium
GSK Investigational Site
Edegem
Malawi
GSK Investigational Site
Blantyre
Time Frame
Start Date: 2022-09-13
Completion Date: 2025-01-07
Participants
Target number of participants: 155
Treatments
Experimental: Stage 1: Invasive nontyphoidal Salmonella (iNTS)-Typhoid conjugate vaccine (TCV) low dose group
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Active_comparator: Stage 1: iNTS-Generalized modules for membrane antigens (GMMA) + TCV low dose group
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Experimental: Stage 1: iNTS-TCV full dose group
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Active_comparator: Stage 1: iNTS-GMMA + TCV full dose group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Placebo_comparator: Stage 1: Placebo group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Experimental: Stage 2: iNTS-TCV full dose group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Active_comparator: Stage 2: iNTS-GMMA + TCV full dose group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
Active_comparator: Stage 2: Control group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
Sponsors
Collaborators: Bill and Melinda Gates Foundation, Wellcome Trust, Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Biomedical Advanced Research and Development Authority
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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