Nha Trang, Vietnam, April 22, 2015 – State-owned vaccine developer, The Institute of Vaccines and Medical Biologicals (IVAC) of Vietnam, today announced results from a Phase 1 clinical trial of its inactivated influenza A/H5N1 pandemic vaccine candidate (IVACFLU-H5N1). The study evaluated the vaccine candidate’s safety and ability to induce an immune response at different dosage levels in healthy adults. Overall results showed the vaccine candidate to be well tolerated and immunogenic.
The study was sponsored by IVAC, conducted in the Ben Luc district of Vietnam’s Long An province by Pasteur Institute Ho Chi Minh City, and authorized by Vietnam’s Ministry of Health. Funds for the study were provided by the World Health Organization (WHO) through a grant from the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services. PATH, an international nonprofit organization, provided technical support under a cooperative agreement with BARDA.
A total of 75 healthy men and women 18 through 30 years of age participated in this Phase 1 double-blind, randomized, placebo-controlled trial and received two doses of IVACFLU-H5N1 at either a high or low dose, or a phosphate buffered saline placebo. Thirty-two volunteers received the high dose of IVACFLU-H5N1 at 15 mcg/0.5 ml and 31 volunteers received the low dose at 7.5 mcg/0.5 ml. Twelve volunteers received placebo. No serious local or systemic adverse events were reported and the high-dose of IVACFLU-H5N1 was shown to be immunogenic according to standard testing methods.
“We are pleased to announce the results of this Phase 1 clinical trial, which confirm the readiness of IVACFLU-H5N1 to progress into Phase 2/3 clinical trials” stated Dr. Le Van Be, director of IVAC. “We look forward to working with our longstanding colleagues at BARDA, WHO, and PATH as we advance this vaccine candidate toward eventual licensure and commercial-scale manufacture for domestic, regional, and global use in the event of a pandemic.”
Influenza is an important cause of morbidity and mortality worldwide. Seasonal influenza causes 250,000 to 500,000 deaths and up to 5 million cases of severe illness each year. If a highly virulent pandemic strain were to emerge, influenza could cause millions of deaths around the world. Vietnam records more than a million cases of influenza-like illness each year and has also experienced isolated human cases of avian influenza A/H5N1, which has a particularly high case-fatality rate. The strain is being monitored to see if it will evolve and adapt into a form that spreads efficiently among people, increasing the likelihood for a possible pandemic.
IVAC’s efforts to develop an influenza A/H5N1 vaccine that can be locally produced in Vietnam will not only benefit the people of Vietnam (who do not yet have a steady domestically manufactured supply of influenza vaccine), they will also make progress toward increasing regional and global influenza vaccine supplies for addressing pandemic influenza. With the world’s influenza vaccine development and production resources mostly concentrated among a limited number of manufacturers, current global vaccine production falls significantly short of need and leaves many middle- and low-income countries without access to these lifesaving tools. The participation of more influenza vaccine suppliers, like IVAC, is vital for sustainably addressing this gap, particularly in a pandemic.
About IVAC
IVAC, established in 1978 by Vietnam’s Ministry of Health, plans and carries out the production of vaccines and serum for the Expanded Program on Immunization in Vietnam and the overall prevention and treatment of diseases. IVAC conducts research and applies technological advances in vaccine development and production in cooperation with organizations in country and abroad. IVAC’s main facility is located in Nha Trang, Vietnam, with other facilities in Suoi Dau.
www.ivac.com.vn
