Hilleman Begins Clinical Trials for Rotavirus, Cholera Vaccines in B’desh
New Delhi: Delhi-based vaccine research organisation Hilleman Laboratories has initiated clinical trials for its heat-stable rotavirus vaccine and cholera vaccine in Bangladesh, according to the company’s chief executive officer, Davinder Gill. If proven safe and immunogenic (able to provoke an immune response in the body), the vaccines could be brought to India as early as 2020 and help bridge some of the gap in vaccination delivery, he said. Hilleman Labs received approvals to conduct Phase I and II clinical trials for the two vaccines in recent weeks from the Directorate General of Drug Administration (DGDA), the drug regulator in Bangladesh, Gill told ET. The trials, in collaboration with Bangladeshbased International Centre for Diarrhoeal Disease Research (ICDDR), will establish the safety and immunogenicity of the vaccines in adults and infants and would take around three years to complete, he said.
The organisation could seek licensure based on the non-inferiority date for its rotavirus vaccine within the four-year timeline as it is a heat-stable formulation of an existing vaccine. “Once we have established the early safety and immunogenicity, we can advance our phase II & III trials quickly,” said Gill.
While it is too early to say whether this approach would be possible with its cholera vaccine, it is an option Hilleman Labs would explore with its cholera vaccine, he added. “If we are able to demonstrate clear non-inferiority (with the cholera vaccine, which is a new design altogether) that gives us a possibility to seek licensure based on this clinical trial,” he said.
These vaccines, especially the heat-stable rotavirus vaccine that can withstand extreme climates, would help India bridge the vaccine delivery gap caused by a high dependence on cold chain systems for preservation. According to Gill, around 50% of vaccines in the country are wasted for reasons, including their dependence on a fully functioning cold chain supply infrastructure.
Hilleman got nods for Phase I and II clinical trials for the two vaccines in recent weeks from the drug regulator in Bangladesh