Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-28

Study Completion Date

2017-02-15

Brief Summary

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

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Detailed Description

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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

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Typhoid Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, Ascending Dose

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study vaccine will be administered by an unblinded staff member at the clinic

Study Groups

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Typhax 0.5 mcg

Vaccine was administered IM on Days 0 and 28 (n=9).

Group Type EXPERIMENTAL

Typhax (investigational typhoid fever candidate vaccine)

Intervention Type BIOLOGICAL

Typhax 2.5 mcg

Vaccine was administered IM on Days 0 and 28 (n=9).

Group Type EXPERIMENTAL

Typhax (investigational typhoid fever candidate vaccine)

Intervention Type BIOLOGICAL

Typhax 10 mcg

Vaccine was administered IM on Days 0 and 28 (n=9).

Group Type EXPERIMENTAL

Typhax (investigational typhoid fever candidate vaccine)

Intervention Type BIOLOGICAL

Typhim Vi 25 mcg

Vaccine was administered IM Day 0 (n=9) followed by placebo control on Day 28

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo is administered to the control group on Day 0 and 28

Active Comparator Typhim Vi

Intervention Type BIOLOGICAL

A single dose of commercial typhoid fever vaccine Typhim Vi is administered on Day 0, followed by placebo control on Day 28

Placebo (saline)

Placebo control was administered IM Days 0 and 28 ( n=9)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo is administered to the control group on Day 0 and 28

Interventions

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Typhax (investigational typhoid fever candidate vaccine)

Intervention Type BIOLOGICAL

Placebo

Placebo is administered to the control group on Day 0 and 28

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adult men or women who are not pregnant or planning to become pregnant during study duration aged 18 to 55 years.
* Clinical laboratory parameters within normal laboratory limits or not found to be clinically significant by the PI

Exclusion Criteria

* Relevant history of physical or psychiatric illness or medical disorder that required treatment.
* Known or suspected hypersensitivity to investigational product
* Immunocompromised subjects
* Previous Typhoid vaccination or elevated anti-Vi antibodies at screening
* Known history of Typhoid infection in the previous 6 months
* Positive HIV, HBsAg, or HCV screen
* Any other condition or abnormality that, in the opinion of the Investigator, may compromise the safety of the patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes