An expert committee of India’s apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has recommended that government-affiliated drugmaker Indian Immunologicals Limited (IIL) be allowed to conduct Phase I clinical trials of the country’s first vaccine for the Zika virus.
The vaccine has been developed in partnership with Australia’s Griffith University. Zika is a mosquito-borne infection primarily transmitted by Aedes mosquitoes, with no vaccines currently available against the disease, according to UNICEF.
The recommendation to proceed with trials was given to Human Biologicals Institute (HBI), the human health division of IIL, by the CDSCO’s Subject Expert Committee (SEC) on vaccines, according to the panel’s minutes of the meeting dated November 12, reviewed by Business Standard.
The recommendation came nearly two months after HBI first submitted its Phase I clinical trial protocol to the panel in September this year.
The protocol proposed a randomised, double-blind, placebo-controlled study to evaluate the safety, reactogenicity and immunogenicity of a recombinant live attenuated Zika vaccine (freeze-dried) in healthy adult volunteers aged 18 to 50 years.
At its September meeting, the committee had noted that while the firm had completed acute-dose and repeat-dose toxicity studies, along with animal immunogenicity and challenge studies, it had not submitted the scientific rationale for selecting the dose for the Phase I study.
The panel had also sought statistical justification for the proposed sample size, the 3:1 randomisation ratio and the selection of cohorts based on non-clinical study findings.
It added that HBI had submitted only a summary of the non-clinical studies rather than the complete study reports.
“In view of the above and after detailed deliberation, the committee recommended that the firm should submit the above information for further deliberation,” the SEC had stated at its September 23 meeting.
At its November meeting, the SEC reconsidered the proposal after HBI submitted the scientific rationale for dose selection and complete non-clinical study reports covering single-dose and repeat-dose toxicity, including immunogenicity studies.
The recommendation comes two years after IIL signed a memorandum of agreement (MoA) with the Indian Council of Medical Research (ICMR) to develop India’s first recombinant live attenuated Zika vaccine.
Under the agreement, ICMR will bear the costs of Phase I clinical trials, including expenses related to trial conduct, investigations and monitoring. The trials will be conducted at ICMR network sites across India.
The SEC’s recommendation is a regulatory step towards initiating human trials. The commencement of the study will depend on subsequent regulatory permission and trial-related arrangements.
While Zika infection is typically mild and often does not require specific treatment, it can have severe consequences for pregnant women, potentially causing microcephaly and other congenital abnormalities in infants.
In some cases, Zika infection may also result in Guillain-Barré syndrome (GBS), a neurological disorder.
India has experienced sporadic, localised outbreaks of Zika virus since its first confirmed cases in 2016. No confirmed cases of Zika-associated microcephaly or GBS have been reported in the country to date.
