Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Matrivax Research and Development Corporation45 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Typhoid Fever

Interventions

Typhax (investigational typhoid fever candidate vaccine)BIOLOGICAL

PlaceboBIOLOGICAL

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

Active Comparator Typhim ViBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Typhax

Solicited Injection Site reactions: Pain, Tenderness, Erythema, Induration; Solicited Systemic Reactions Fever, Headache, Joint Pain, Joint Swelling, Fatigue, Myalgia, Nausea, Vomiting, Diarrhea

Time frame: Days 0 up to Day 56 (= 28 Days post second vaccination)

Number of participants reporting adverse events following vaccination with Typhax

Adverse events are assessed at study visits by PI for seriousness, relationship to investigational product , severity and other possible etiologies

Time frame: Days 0 up to Day 210

Anti-Vi IgG antibody seroconversion and geometric mean antibody titers

The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 14 after vaccination.

Time frame: Day 0 - Day 14

Anti-Vi IgG antibody seroconversion and geometric mean antibody titers

The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 28 after vaccination.

Time frame: Day 0 - Day 28

Anti-Vi IgG antibody seroconversion and geometric mean antibody titers

The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 42.

Time frame: Day 0 - Day 42

Anti-Vi IgG antibody seroconversion and geometric mean antibody titers

The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 180.

Time frame: Day 0 - Day 180.

Secondary Outcomes

Data from ClinicalTrials.gov

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