Two years after researchers at the All India Institute of Medical Sciences (AIIMS) developed an oral vaccine for hepatitis B, the project has moved an inch closer to completion, with the team generating data to get approval for human trials. The vaccine has already been tested successfully on mice and guinea pigs. Approval for human trials has to be given by the Director Controller General of India (DCGI).
The research, funded by the Department of Biotechnology, was published in the journal, Vaccine, in 2016 and is expected to see the light of day by 2021. In India, as per latest estimates, 40 million people are chronically infected by hepatitis B.
“The process is already on. We are now generating data to apply to the DCGI. We will then be able to conduct human trials… After getting approval, it may take two-three years to be fully completed. If we receive positive results through human trials, the vaccine will replace injections,” Dr Amit Dinda, professor, department of pathology, AIIMS, told The Indian Express.
Currently, immunisation against hepatitis B requires injectable vaccines, with the first booster shot after one month, and the second after six months. Once the vaccine is prepared, it will be completely safe, cost-effective and help in mass immunisation.
After validating and assessing the project for around two years, academicians at the medical institute are hoping to look for a commercial firm to support the research project. “The process is on and hopefully we will enter into a partnership with a commercial firm by 2019,” added Dr Dinda.
During the research, the team developed nano-particles loaded with antigen protein segments. Experts feel that the use of nanocarrier for oral delivery of antigen may help it escape the acid environment of the stomach.“If everything falls into place, this is going to be a major discovery in the field of medicine. This vaccine is easily injectable and reduces the need for cold storage of medicines. It is like a dry powder and will also do away with the risk of blood-borne infections such as HIV,” said Dr Dinda.
As per the World Health Organisation, hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic diseases. The virus is transmitted through contact with blood or other body fluids of an infected person. A vaccine against hepatitis B has been available since 1982.The vaccine is 95% effective in preventing infection and development of chronic disease and liver cancer.