The Indian Council of Medical Research has started work on a vaccine against the Zika virus, in collaboration with vaccine manufacturer Indian Immunologicals Limited (IIL), people familiar with the matter said.
IIL has signed a memorandum of association (MoA) with ICMR for the clinical development of the vaccine — the country’s first codon de-optimised live attenuated vaccine against Zika — and Phase I clinical trial is likely to start soon, the people said.
Zika is mostly a mosquito-borne viral infection transmitted by Aedes mosquitoes. It can also be transmitted to foetus during pregnancy, through sexual contact, blood transfusion and organ transplantation.
The disease is usually mild and requires no specific treatment. However, it is more serious when infection occurs during pregnancy which may cause microcephaly and other congenital malformations in the infant, preterm birth and even miscarriage.
In India, Zika cases have been reported from several states. According to the Union ministry of health and family welfare data, as on July 22, there are 537 Zika cases reported from across the country.
Currently, there is no vaccine for its prevention. IIL partnered with Griffith University, Australia, to develop the codon de-optimized live attenuated Zika vaccine that has completed extensive pre-clinical evaluations and received permission from Indian regulatory authority to produce GMP (good manufacturing) grade materials for clinical developmental work.
{{/usCountry}}Currently, there is no vaccine for its prevention. IIL partnered with Griffith University, Australia, to develop the codon de-optimized live attenuated Zika vaccine that has completed extensive pre-clinical evaluations and received permission from Indian regulatory authority to produce GMP (good manufacturing) grade materials for clinical developmental work.
{{/usCountry}}The codon is the fundamental unit of significant correlation between nucleic acids and proteins that transfer information between them. Genetic code is a set of codons, and codon deoptimisation is an efficient way of weakening the virus as the method can modify the expression of a gene or attenuate a virus by changing codons in a genome.
According to the MoA, ICMR will fund the Phase I clinical trial costs including the costs relating to the conduct, investigations and monitoring of clinical trial. The trial will be conducted at the ICMR network sites in India.
“ICMR’s Phase I trial network, launched last year, facilitates first-in-human safety studies for innovative and affordable Frontier MedTech, including small molecules, biologics, and vaccines. With four Phase-I sites—ACTREC Mumbai, KEM Hospital Mumbai, SRM Chennai, and PGIMER Chandigarh—fully operational, Indian innovators no longer need to go abroad for Phase-I trials. This is a significant step towards achieving Atmanirbhar Bharat and Viksit Bharat,” said Rajiv Bahl, director-general-ICMR.
K Anand Kumar, managing director, Indian Immunologicals Limited, said, “It is a great moment for IIL to collaborate with ICMR to develop Zika vaccine. IIL has been the single largest contributor to India achieving self-sufficiency in the field of vaccines. Our foresight on the development of novel vaccine platforms including codon de-optimized viral vaccines is beginning to bear fruit. It is essential to safeguard our people from emerging diseases by developing safe and effective vaccines that are affordable.”