Safety and Immunogenicity of Typhax, a Typhoid Vaccine

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Brief Title

Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Official Title

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

Brief 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Vi-specific B-cell ELISPOT responses

Condition

Typhoid Fever

Intervention

Typhax (investigational typhoid fever candidate vaccine)

Study Arms / Comparison Groups

 Typhax 0.5 mcg
Description:  Vaccine was administered IM on Days 0 and 28 (n=9).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

45

Start Date

March 28, 2016

Completion Date

February 15, 2017

Primary Completion Date

February 15, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Administrative Informations


NCT ID

NCT03926455

Organization ID

Typhax-101


Responsible Party

Sponsor

Study Sponsor

Matrivax Research and Development Corporation


Study Sponsor

, , 


Verification Date

April 2019