Safety and Immunogenicity of Typhax, a Typhoid Vaccine

NCT03926455 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Typhax-101
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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.

  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.

  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.

  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.

  Day 0 - Day 180.

Secondary Outcomes (1)

• Vi-specific B-cell ELISPOT responses

  Days 0 through 38

Study Arms (5)

Typhax 0.5 mcg

EXPERIMENTAL

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

Biological: Typhax (investigational typhoid fever candidate vaccine)

Typhax 2.5 mcg

EXPERIMENTAL

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

Biological: Typhax (investigational typhoid fever candidate vaccine)

Typhax 10 mcg

EXPERIMENTAL

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

Biological: Typhax (investigational typhoid fever candidate vaccine)

Typhim Vi 25 mcg

ACTIVE COMPARATOR

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

Biological: Placebo; Biological: Active Comparator Typhim Vi

Placebo (saline)

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Typhax (investigational typhoid fever candidate vaccine) BIOLOGICAL

Typhax 0.5 mcg; Typhax 10 mcg; Typhax 2.5 mcg

Placebo BIOLOGICAL

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

Placebo (saline); Typhim Vi 25 mcg

Active Comparator Typhim Vi BIOLOGICAL

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

Typhim Vi 25 mcg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matrivax Research and Development Corporation: lead

Related Publications (1)

• Cartee RT, Thanawastien A, Griffin Iv TJ, Mekalanos JJ, Bart S, Killeen KP. A phase 1 randomized safety, reactogenicity, and immunogenicity study of Typhax: A novel protein capsular matrix vaccine candidate for the prevention of typhoid fever. PLoS Negl Trop Dis. 2020 Jan 6;14(1):e0007912. doi: 10.1371/journal.pntd.0007912. eCollection 2020 Jan.

  PMID: 31905228 DERIVED

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study vaccine will be administered by an unblinded staff member at the clinic
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Ascending Dose

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: March 28, 2016
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share