NCT03926455

Safety and Immunogenicity of Typhax, a Typhoid Vaccine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Matrivax Research and Development Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	Typhax (investigational typhoid fever candidate vaccine)
BIOLOGICAL	Placebo	Placebo is administered to the control group on Day 0 and 28
BIOLOGICAL	Active Comparator Typhim Vi	A single dose of commercial typhoid fever vaccine Typhim Vi is administered on Day 0, followed by placebo control on Day 28

Timeline

• Start date: 2016-03-28
• Primary completion: 2017-02-15
• Completion: 2017-02-15
• First posted: 2019-04-24
• Last updated: 2019-04-24

Regulatory

• FDA-regulated drug study