Safety and Immunogenicity of Typhax, a Typhoid Vaccine

Typhoid Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926455
• Other study ID #: Typhax-101
• Status: Completed
• Phase: Phase 1
• Start date: March 28, 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2019
• Source: Matrivax Research and Development Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

Biological:
• Typhax (investigational typhoid fever candidate vaccine)

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Matrivax Research and Development Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Vi-specific B-cell ELISPOT responses	Immunogenicity was evaluated by comparing the number of Vi-specific B-cells by ELISPOT in PBMC samples	Days 0 through 38