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Institute of Vaccine and Medical Biologicals
Positive Phase 1 results announced for seasonal influenza vaccine candidate made locally in Vietnam
Contact: Dr. Le Van Be, Director, Institute of Vaccines and Medical Biologicals. Tel: +84 58 3 822 408, +84 58 3 818 898, +84 903501529.
Nha Trang, Vietnam, September 27, 2016 – 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 seasonal influenza vaccine candidate (IVACFLU-S) which targets three strains of influenza: A/H1N1, A/H3N2, and B. The study evaluated the vaccine candidate’s safety and ability to induce an immune response in healthy adults. Overall results showed the vaccine candidate to be well tolerated and immunogenic.
The study was sponsored by IVAC, conducted in the Hung Ha district of Vietnam’s Thai Binh province by the National Institute of Hygiene and Epidemiology (NIHE), 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 60 healthy men and women 18 through 45 years of age participated in this Phase 1 double-blind, randomized, placebo-controlled trial and received one dose of IVACFLU-S, or a phosphate buffered saline placebo. 30 volunteers received IVACFLU-S at 15 mcg/0.5 ml and 30 volunteers received placebo. No serious local or systemic adverse events were reported and IVACFLU-S was shown to be immunogenic according to standard testing methods. 
“We’re thrilled to announce that Phase 1 clinical trial results confirm the safety and potential of IVACFLU-S to protect Vietnam against deadly influenza,” said Dr. Le Van Be, Director, Institute of Vaccines and Medical Biologicals.  “We look forward to working with our colleagues at BARDA, WHO, and PATH to progress the vaccine candidate into Phase 2/3 clinical trials and eventual licensure and commercial-scale manufacture.”
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 year-round seasonal influenza circulation and has also experienced isolated human cases of avian influenza A/H5N1, which has a particularly high case-fatality rate. 
Vietnam currently has no domestically-produced supply of influenza vaccine, which forces the country to look beyond its borders to obtain these lifesaving tools for its people. The best way to ensure Vietnam’s access to influenza vaccines is to develop domestic capacity to produce high-quality, affordable seasonal vaccines, which would maintain manufacturing capacity on an ongoing basis and enable Vietnam to sustainably equip itself against both seasonal and pandemic influenza outbreaks. IVAC’s efforts to develop a seasonal influenza vaccine that can be locally produced in Vietnam will not only benefit the people of Vietnam, they will also make progress toward increasing regional and global influenza vaccine supplies. 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. 
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
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Photos courtesy by PATH/Nguyen Phu Cuong