An indigenous malaria vaccine the first and the only one to be transferred to the industry for clinical trial - has failed, prolonging the wait for a life-saving shot against the mosquito-borne disease.
Developed by researchers at Delhi-based International Centre for Genetic Engineering and Biotechnology, the vaccine was transferred to Hyderabad-based Bharat Biotech in May 2010 with much fanfare for the clinical trial.
But since the vaccine performed poorly in the phase-1 clinical trial on 45 healthy volunteers, it was decided not to proceed further with the malaria vaccine, named Jaivac-1.
Created by ICGEB scientist Chetan Chitnis and his colleague V S Chauhan with their team members after two decades of research, Jaivac-1 was developed against the killer malaria parasite Plasmodium falciparum. It was found safe in animal studies.
The vaccine comprises two proteins. The trial results showed one of the proteins didn't work whereas the other did. But since the clinical vaccine was a combination of both, it couldn't be taken to the next step because of its poor performance.
"The phase-I clinical trial showed while one protein (name: PfEBA175-PfF2) produced immune response and elicited growth inhibitory antibodies, the second protein (PfMSP1-19) was poorly immunogenic. It was, therefore, decided not to proceed further with clinical development of Jaivac-1," Chitnis, who now works at the Pasteur Institute in Paris told DH.
Asked to comment on the failure of the malaria vaccine after two decades of research and development, ICGEB director Dinakar Salunke said, "The open-ended conventional trial-and-error vaccine development efforts are always subject to this worry. Such efforts need to be accompanied by major efforts to gain mechanistic understanding so that they can become less trial-and-error."
Chitnis's team received nearly Rs 12 crore research funding for the malaria vaccine.
After the failure, ICGEB researchers tweaked Jaivac-1 by modifying the non-responsive protein with the addition of another protein (a peptide).
Named Jaivac-2, the tweaked vaccine was transferred to Zydus Cadila for producing the vaccine for toxicology studies and Phase I Clinical Trials.
"Toxicology study was completed and an investigational new drug application is currently being submitted to the Drugs Controller General of India for permission to conduct a Phase I trial," said Chitnis, a winner of the Rs 50 lakh Infosys Prize.
Outside the African continent, India is the only nation in the world where malaria continues to be a public health problem. Majority of the malaria cases in India are the deadly ones caused by the parasite Plasmodium falciparum.