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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Clinicaltrials.gov identifier NCT03926455

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Typhoid Fever
  • Intervention/Treatment: Biological: Typhax (investigational typhoid fever candidate vaccine)
    Biological: Placebo
    Biological: Active Comparator Typhim Vi
  • Phase: Phase 1
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 45 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: Randomized, Ascending Dose
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention
  • Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Trial to Determine the Safety and Immunogenicity of Typhax Delivered IM
  • Actual Study Start Date: March 2016
  • Actual Primary Completion Date: February 2017
  • Actual Study Completion Date: February 2017
Arms and interventions
Arm Intervention/treatment
Experimental: Typhax 0.5 mcg
Vaccine was administered IM on Days 0 and 28 (n=9).
Biological: Typhax (investigational typhoid fever candidate vaccine)
Experimental: Typhax 10 mcg
Vaccine was administered IM on Days 0 and 28 (n=9).
Biological: Typhax (investigational typhoid fever candidate vaccine)
Experimental: Typhax 2.5 mcg
Vaccine was administered IM on Days 0 and 28 (n=9).
Biological: Typhax (investigational typhoid fever candidate vaccine)
Placebo Comparator: Placebo (saline)
Placebo control was administered IM Days 0 and 28 ( n=9)
Biological: Placebo
Placebo is administered to the control group on Day 0 and 28
Active Comparator: Typhim Vi 25 mcg
Vaccine was administered IM Day 0 (n=9) followed by placebo control on Day 28
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
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Typhax [ Time Frame: Days 0 up to Day 56 (= 28 Days post second vaccination) ]
    Solicited Injection Site reactions: Pain, Tenderness, Erythema, Induration; Solicited Systemic Reactions Fever, Headache, Joint Pain, Joint Swelling, Fatigue, Myalgia, Nausea, Vomiting, Diarrhea
  • 2. Number of participants reporting adverse events following vaccination with Typhax [ Time Frame: Days 0 up to Day 210 ]
    Adverse events are assessed at study visits by PI for seriousness, relationship to investigational product , severity and other possible etiologies
  • 3. Anti-Vi IgG antibody seroconversion and geometric mean antibody titers [ Time Frame: Day 0 - Day 14 ]
    The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 14 after vaccination.
  • 4. Anti-Vi IgG antibody seroconversion and geometric mean antibody titers [ Time Frame: Day 0 - Day 28 ]
    The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 28 after vaccination.
  • 5. Anti-Vi IgG antibody seroconversion and geometric mean antibody titers [ Time Frame: Day 0 - Day 42 ]
    The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 42.
  • 6. Anti-Vi IgG antibody seroconversion and geometric mean antibody titers [ Time Frame: Day 0 - Day 180. ]
    The immunogenicity will be measured by ELISA for anti-Vi percent seroconversion and GMTs before and at day 180.
  • Secondary Outcome Measures: 1. Vi-specific B-cell ELISPOT responses [ Time Frame: Days 0 through 38 ]
    Immunogenicity was evaluated by comparing the number of Vi-specific B-cells by ELISPOT in PBMC samples
Eligibility Criteria
  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Matrivax Research and Development Corporation

More Information
  • Responsible Party: Matrivax Research and Development Corporation
  • ClinicalTrials.gov Identifier: NCT03926455 History of Changes
  • Other Study ID Numbers: Typhax-101
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Typhoid Fever