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Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Typhoid Fever Clinical Trial

Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Trial to Determine the Safety and Immunogenicity of Typhax Delivered IM

Clinical Trial Summary

This was a randomized, double-blind, ascending dose study conducted at a single clinical research center.

Clinical Trial Description

Healthy adult subjects aged 18 to 55 years were assigned to 3 ascending dose cohorts of Typhax (0.5, 2.5 or 10 mcg Vi antigen). Groups of 15 subjects in each dose cohort were randomized to receive Typhax, Typhim Vi (25 mcg Vi antigen) or placebo (saline) in a ratio of 3:1:1, respectively. Typhax and placebo (saline) was administered as two dose regimen (Days 0 and 28), and Typhim Vi was given as a single dose (Day 0) with matching placebo on Day 28. All doses were administered by a unblinded third-party as 0.5 mL by intramuscular (IM) injection. Safety and reactogenicity endpoints was assessed at 14 and 28 days after the first Typhax vaccination and 14 days after the second vaccination. Immunogenicity was assessed using an enzyme-linked immunosorbent assay (ELISA) to measure anti-Vi antibody serum titers on days 0, 14, 28, 42 and 180. A positive immune response (seroconversion) by ELISA is defined as at least a 4-fold increase over baseline in the Vi-specific ELISA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03926455
Study type Interventional
Source Matrivax Research and Development Corporation
Contact
Status Completed
Phase Phase 1
Start date March 28, 2016
Completion date February 15, 2017
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