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Safety and Immunogenicity of Typhax, a Typhoid Vaccine

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ClinicalTrials.gov Identifier: NCT03926455
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Matrivax Research and Development Corporation

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

Condition or disease Intervention/treatment Phase
Typhoid Fever Biological: Typhax (investigational typhoid fever candidate vaccine) Biological: Placebo Biological: Active Comparator Typhim Vi 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Randomized, Ascending Dose
Masking: Double (Participant, Investigator)
Masking Description: Study vaccine will be administered by an unblinded staff member at the clinic
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 28, 2016
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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 2.5 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)
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

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matrivax Research and Development Corporation
ClinicalTrials.gov Identifier: NCT03926455    
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections