Drug maker Zydus Cadila will start phase 2 clinical trials to establish the efficacy of its anti-coronavirus disease (Covid-19) vaccine candidate from Thursday, the company said on Wednesday.
“…its plasmid DNA vaccine to prevent Covid-19, ZyCoV-D, was found to be safe and well tolerated in the Phase I clinical trial. The company will now commence Phase II clinical trials from the 6th of August, 2020…the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on 15th July 2020, has been well tolerated,” Zydus Cadila said in a statement.
The vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies conducted on animals. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies.
The company received the central drugs controller’s approval for human trials on July 2
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said Pankaj R Patel, chairman, Zydus Cadila.
“All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” he added.
The company has not made the trial results public yet.
The Phase II study of ZyCoV-D will be conducted in over 1,000 healthy adult volunteers.
“The 7 day safety of the vaccine in all the subjects enrolled in the Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial,” the company said.
According to the company, the vaccine candidate is safer because of its DNA vaccine platform, which requires injecting genetically engineered plasmid (small DNA molecule) containing the DNA sequence encoding the antigen(s) against which an immune response is sought.
“…the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much improved vaccine stability and lower cold chain requirements, making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection,” the company said.
The plasmid DNA, when introduced into the host cells. would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.
The vaccine candidate was developed indigenously at the company’s Vaccine Technology Centre in Ahmedabad, Gujarat.
Experts in the government have maintained that India will take the lead in manufacturing the Covid-19 vaccine when it is developed. “There we will take the lead as we have the requisite manufacturing capacity,” says Dr VK Paul, member, Niti Ayog, and also chairman of one of the national task forces on Covid-19.