HIV or Human Immunodeficiency Virus is a retrovirus that results in a condition known as AIDS or Acquired Immunodeficiency Syndrome. Individuals with HIV/AIDS have a weakened immune system that makes them susceptible to variety of infections and cancers to which a normal individual would be resistant. HIV infection spreads through contact with bodily fluids such as blood, semen, vaginal fluid or breast milk. Therefore activities such as sexual intercourse, sharing of syringes or breast feeding by infected mother and transfusion of infected blood can cause the spread of HIV. However simple activities such as shaking of hands, sharing of toilet seat do not cause the transmission of HIV.
Currently there is no vaccine for HIV/AIDS however researchers are fervently working towards one and it appears that researcher Chil-Yong Kang and his team are close to achieving this goal.
These group of researchers at Canada’s western university‘s Schulich School of Medicine & Dentistry have successfully completed PHASE I clinical trials on 33 retro positive volunteers, (HIV infected individuals) with a HIV vaccine code named “SAV001”. This vaccine is manufactured for the clinical trial by the pharmaceutical division of Sumagen Co. Ltd in Canada; the company is of South Korean origin and also holds the patent for the vaccine.
The vaccine consists of HIV 1 species which has a higher virulence and infectivity along with a global prevalence as compared to HIV 2 species which has high prevalence only in Africa. The HIV in this vaccine is inactivated and consists of the whole virus. The HIV was genetically modified using Honey bee DNA to render it harmless. The vaccine was then administered to the test subjects in whom as a result an immune response was seen in the PHASE I trial. This showed that the test subjects could tolerate the vaccine with no serious adverse effects which otherwise would have sent the researchers back to the drawing board.
It is now to be seen in the PHASE II clinical trial if this immune response that was produced can prevent HIV infection. Since the vaccine consists of the whole virus it should make it effective against all strains of the virus. We will know its effectivity in the later stages of the clinical trial.
The US FDA was satisfied with the finding to grant an approval for the PHASE II trial making this the world’s first such vaccine for HIV/AIDS to be granted such an approval. In this phase of the clinical trial there will be a total of 600 test subjects which as per the test protocol will be divided into groups of 2 with 300 subjects in each. One group will consists of low risk individuals and the other with high risk individuals who are more likely to acquire HIV infection such as homosexuals, drug users and people with HIV positive partners, etc.
If this trial is successful then the PHASE III trial would be conducted at a world wide scale with around 6000 or more subjects to account for multiple population variables. This will take several years; usually it takes 11 years or more for the whole process of drug discovery to market entry to be completed. However, the progress and results so far make me hopeful for a positive outcome that will save millions of lives around the world.
----Raghuvir Keni
REFERENCES:
1. Choi E, Michalski C, Choo S, Kim G, Banasikowska E, Lee S et al. First Phase I human clinical trial of a killed whole-HIV-1 vaccine: demonstration of its safety and enhancement of anti-HIV antibody responses. Retrovirology. 2016;13(1).
2. WESTERN UNIVERSITY, CANADA. Western virologist hopes to test vaccine on 600 HIV-negative subjects next fall [Internet]. 2016. Available from: http://mediarelations.uwo.ca/2016/12/01/western-virologist-hopes-test-vaccine-600-hiv-negative-subjects-next-fall/
3. Data and statistics [Internet]. World Health Organization. 2017 [cited 21 January 2017]. Available from: http://www.who.int/hiv/data/en/
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