Nha Trang Institute of Vaccines & Medical Biologicals (IVAC) has successfully produced influenza vaccine A/H5N1 for human use
Nha Trang Institute of Vaccines & Medical Biologicals (IVAC) has successfully produced influenza vaccine A/H5N1 for human use after 12 years of research. The vaccine is currently under a final clinical trial on humans. The vaccine is expected to be approved and licensed for use in 2018.
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| Purifying by sucrose gradient on ultracentrifuge. |
A/H5N1 flu is a fatal disease with the mortality rate of about 50% among humans. However, no treatment or drugs for the avian influenza virus infection has been found so far. Since 2003, A/H5N1 epidemic has stricken many countries. 127 human cases of A/ H5N1 with 63 deaths have been reported in Vietnam. Influenza viruses constantly undergo genetic changes and thus it may cause an epidemic, according to Associate professor, PhD Tran Nhu Duong, Deputy Director of the National Institute of Hygiene & Epidemiology.
Under the request by the Ministry of Health together with the financial and technological assistance by World Health Organization (WHO) and PATH (U.S.A), from 2005 to 2010, IVAC successfully developed small-scale influenza vaccine A/H5N1 production in labs for human use. Then, under the support of WHO, IVAC constructed an international standard large-scale vaccine factory with a capacity of 3 million doses of influenza vaccine A/H5N1 a year. In 2011-2013, IVAC continued receiving support from WHO and PATH to develop clinical test technology on humans and animals,
The pre-clinical test results on animals (rabbits and ferrets) in labs proved the product safety and immunogenicity. In 2014, the Ministry of Health allowed a clinical test on humans. Ho Chi Minh Pasteur Institute (first phase) and the National Institute of Hygiene & Epidemiology (second and third phases) conducted a research under the supervision by FHI 360 organization together with the technical support provided by WHO and PATH.
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| Influenza vaccine A/H5N1 produced by IVAC. |
From April till August 2014, the clinical trial of an inactivated influenza A/H5N1, involving 75 participants aged between 18 and 45 in Ben Luc District, Long An Province proved efficacious and safe. The 2nd phrase trial with 300 volunteers participating in the test in Ninh Quang, Ninh Da and Ninh Binh, Ninh Hoa Town. No serious local or systemic adverse events were reported and the vaccine dose was shown to be immunogenic according to standard testing methods.
Therefore, the Ministry of Health has approved a large-scale third phase clinical trial on humans to assess the safety of the 15 mcg dose. 630 people in Tien Lang District (Hai Phong City) and Ninh Hoa Town (Khanh Hoa Province) are expected to participate in the final clinical trial. If the trial is successful, the vaccine will be licensed for use in 2018, says PhD Duong Huu Thai, Deputy Director of IVAC. On April 12, the final trail vaccine dose was given to 269/270 volunteers. The trial proved the safety of the vaccine. In Khanh Hoa Province, the trail vaccination is scheduled to take place in May and June with the participation of 360 volunteers divided into 2 groups aged 18-40 and 41-60, according to the National Institute of Hygiene & Epidemiology.
Vietnam will be among few countries which is able to successfully produce A/H5N1 influenza vaccine. A/H5N1 influenza vaccine is produced from eggs, purified by sucrose gradient on ultracentrifuge, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL. In 2013, IVAC researched and produced A/H7N9 and H1N1 flu vaccines against 3 types of seasonal influenza.
The successful production of A/H5N1 vaccines has contributed to the vaccine achievement in Vietnam and in the world.
T.L
Translated by N.T
