NCT02171819

Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1

A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

Detailed description

This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample size was selected to enable at least 30 evaluable subjects in each of the groups receiving active vaccine. The study will utilize a "block randomization" to assure a balance of 8:8:3 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. Since this is a first-in-human study, all injections of study product will be sequential and staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and the remaining 57 study subjects for both the 1st and 2nd doses in the study. A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of the study group by approximately 2-3 weeks. Product administration for both injections of vaccine or placebo will be sequential and staggered.

Conditions

• Influenza A Subtype H5N1 Infection

Interventions

Type	Name	Description
BIOLOGICAL	IVACFLU-A/H5N1, 7.5 mcg	Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
BIOLOGICAL	IVACFLU-A/H5N1, 15 mcg	Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
OTHER	Placebo Comparator	PBS, pH 7.2 in 0.5 mL single-dose vials.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-06-24
• Last updated: 2019-03-14
• Results posted: 2019-03-14

Locations

1 site across 1 country: Vietnam