Clinical Trial: A Safety and Immunogenicity Study of IVACFLU-A/H5N1

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2/3 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 I

Brief Summary: The purpose of this study is to determine a safe and effective dose of IVAC A/H5N1 vaccine for licensure in Vietnam. The first phase (Phase 2) will compare two doses of the vaccine. Based on the outcome of the Phase 2, the Vietnam MOH will determine if Phase 3 can be conducted.

Detailed Summary:

This is a Phase 2/3, double-blind, randomized, placebo-controlled trial to test the safety and immunogenicity of two doses given 21 days apart of the IVAC A/H5N1 vaccine. In the Phase 2 study, 300 healthy adult subjects will be randomized to receive 15 mcg of vaccine (n=100), 30 mcg of vaccine (n=100), or saline placebo (n=100). Safety and immunogenicity will be assessed in all 300 subjects. Although full evaluation of the safety will continue through Day 91, there will be an early evaluation of the safety and immunogenicity data collected through Day 43 of Phase 2 to determine whether to proceed to Phase 3 and what dose to select.

A vaccine dose will be selected based on safety and immunogenicity using pre-specified criteria. The conduct of Phase 3 will be dependent on showing an Hemagglutination Inhibition (HAI) response titer of ≥1:40 in 60% or more vaccine recipients in at least one of the two vaccine groups in Phase 2.

The dose selected from Phase 2 will be used in the Phase 3 trial. Phase 3 is a confirmatory study that will expand the safety and immunogenicity in a larger number of subjects to meet product registration in Vietnam. In Phase 3, subjects will be randomized to receive the vaccine dose selected in Phase 2 (n=1,000) or saline placebo (n=500) under double blind. Safety will be assessed in all subjects and immunogenicity will be measured in a subset of approximately 300 subjects receiving the IVACFLU-A/H5N1 (vaccinees) from 500 subjects enrolled at one of 3 study sites (Hai Phong) in Phase 3.

All subjects in Phase 2 and Phase 3 will receive two injections of A/H5N1 vaccine or placebo, 21 days apart. Subjects will be male and female healthy adults from 18 through 60 years of age.


Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam

Current Primary Outcome:

  • The Number and percentage of subjects solicited and unsolicited adverse events (AEs), stratified by age [ Time Frame: 30 minutes post injection ]
    Number and proportion of AEs stratified by 18-40 years of age and 41-60 years age presented as a composite per arm
  • The Number and percentage of subjects solicited and unsolicited adverse events (AEs), stratified by age [ Time Frame: 7 days post injection ]
    Number and proportion of AEs stratified by 18-40 years of age and 41-60 years age
  • The Number and percentage of subjects solicited and unsolicited adverse events (AEs), stratified by age [ Time Frame: 21 days post injection ]
    Number and proportion of AEs stratified by 18-40 years of age and 41-60 years age presented as a composite per arm
  • The Number and percentage of subjects solicited and unsolicited adverse events (AEs), stratified by age [ Time Frame: Day 1 to Day 91 (entire study) ]
    Number and proportion of AEs stratified by 18-40 years of age and 41-60 years age presented as a composite per arm
  • The percentage of subjects achieving at least a four-fold increase in post-vaccination titer, stratified by age [ Time Frame: Day 22 (phase 2) and Day 43 (Phase 2 and 3) as compared to Day 1 pre-injection ]
    This is the same measurement (antibodies to HA) done on blood samples taken pre-injection at Day 1 compared to those taken on Day 22 (for phase 2) and Day 43 (for Phase 2 and 3) of the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institute of Vaccines and Medical Biologicals, Vietnam

Dates:
Date Received: October 15, 2015
Date Started: February 2016
Date Completion: April 2017
Last Updated: November 20, 2015
Last Verified: October 2015