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

Phase 1 Completed 75 enrolled Institute of Vaccines and Medical Biologicals, Vietnam Department of Health and Human Services · collab Institut Pasteur · collab PATH · collab World Health Organization · collab

RandomizedSingle-groupTriple-blindPrevention

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.

Timeline

Start: 2014-06
Primary completion: 2014-08
Completion: 2014-08

Outcome

Met primary endpoint

release “liều cao của IVACFLU-A/H5N1 đã được chứng minh là có miễn dịch” com.vn ↗

Publications

Results Phan TL, Ho VT, Vu MH, Nguyen TN, Duong HT, Holt R, Wahid R, Donnelly J, Flores J. Clinical testing of an inactivated influenza A/H5N1 vaccine candidate in a double-blinded, placebo-controlled, randomized trial in healthy adults in Vietnam. Vaccine. 2016 Oct 26;34(45):5449-5456. doi: 10.1016/j.vaccine.2016.08.055. Epub 2016 Aug 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IVACFLU-A/H5N1	Vaccine	7.5 ug	—
Subject	IVACFLU-A/H5N1	Vaccine	15 ug	—