What if a potential vaccine for malaria was to be first tested in humans before mice and animals? This November, experts at the Indian Council of Medical Research (ICMR) and labs affiliated to the Department of Biotechnology (DBT), will have a first-of-its kind “ethics meeting” here to discuss the feasibility of conducting these so-called ‘human challenge’ trials in India. The meeting will also discuss testing two vaccine-candidates — one that causes falciparum malaria and the milder-but-more-prevalent vivax — developed at the New Delhi-based International Centre for Genetic Engineering and Biotechnology.
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Waste of money
Because vaccines involve injecting the body with a mild strain of a parasite, the traditional approach — for drugs and vaccines — has been to test it in animals and only then, if safe and effective, check them in humans. This approach however has meant that several promising candidates, after tons of investment, fail to live up to expectations and consequently wasted money. Moreover, there are situations where the dosage requirements in people or, the manner in which disease manifests is different from that in animal models. However, not all strains are amenable to a human-first, or Controlled Human Infection Model (CHIM) approach. The strain of parasite, for instance, must only induce as much infection as can be treated by available medicines and only healthy, human volunteers — completely aware of the risks and have given informed consent — ought to be recruited for trials.
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“It has to be a strain that induces an immune response that you are capable of controlling infection… if somebody starts getting sick you should be able to abort the infection,” Gagandeep Kang, Executive Director, Translational Health Science and Technology Institute (a DBT-funded body), told The Hindu . Ms. Kang played a key role in developing India’s first rotavirus vaccine. Challenge trials were being conducted for testing typhoid vaccines at Oxford University, in the United Kingdom as well in other studies in the Netherlands and Africa. “I’m hoping to bring researchers, with experience in this [to the November meeting] and developing CHIMS as a strategy for future vaccine development in India, at my institute,” she added.
Though plans to employ such an approach were discussed three years ago, it didn’t materialise. However Ms. Kang said she’d had several discussions with the ICMR officials, who “were on board in principle” but trials were still a long way off.