India-based Zydus Cadila has launched Phase II clinical trials of its Covid-19 vaccine
ndia-based Zydus Cadila has launched Phase II clinical trials of its Covid-19 vaccine candidate, ZyCoV-D, which showed promise in a Phase I study.
The company completed dosing in the Phase I trial, where the vaccine was found to be safe and well tolerated in healthy participants.
In pre-clinical toxicity studies, the vaccine demonstrated favourable safety, immunogenicity and tolerability. The candidate was observed to induce high level of neutralising antibodies in animals.
Zydus Cadila chairman Pankaj Patel said: “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 seven 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.”
An independent Data Safety Monitoring Board (DSMB) endorsed the seven day safety of the vaccine in all the Phase I participants, noted the company.
The Phase II trial will be performed in more than 1,000 healthy adults. It is part of an adaptive, multi-centric, randomised, double-blind placebo controlled Phase I/II dose escalation study.
ZyCoV-D is a plasmid DNA vaccine candidate. When delivered into the host cells, the plasmid DNA is known to translate into the viral protein and trigger a strong cellular and humoral immune response.
The development of the Covid-19 vaccine candidate was supported by National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India.
Zydus started dosing participants in the Phase I/II clinical trial of ZyCoV-D last month.
The company has already manufactured clinical batches of the vaccine for the human trials. It developed the candidate at its Vaccine Technology Centre in Ahmedabad, Based on the safety profile seen so far, which Zydus said was endorsed by the Data Safety Monitoring Board, the study is set to progress into its larger, 1,000-subject, placebo-controlled phase 2 portion on Thursday.
The milestone continues the speedy advance of the vaccine through the clinic. Zydus wrapped up its preclinical assessments of the vaccine and secured clearance to start clinical trials in early July. Less than two weeks later, Zydus began dosing the first subjects in an adaptive phase 1/2 study. Zydus is set to start the phase 2 portion of the trial three weeks after getting the phase 1 underway.
Zydus’ progress into and through the clinic has benefited from the willingness of the Indian regulator to fast track processes. India is currently averaging more than 50,000 new cases of COVID-19 a day.
The Serum Institute of India has secured a license to AstraZeneca’s COVID-19 vaccine, setting it up to make 400 million doses for low- and middle-income countries by the end of 2020, but with Western governments buying up supplies of other candidates, India may need more local players to step up if it is to embark on a mass-immunization program capable of ending the crisis.
Aspects of Zydus’ vaccine mean that, if it is safe and effective, it may be well suited to use in India. Vaccines that use mRNA to induce an immune response, such as those in development at CureVac, Moderna and BioNTech and Pfizer, typically need to be transported along cold chains. That can make it hard to ship the vaccines in industrialized countries. In rural India, the requirement could severely limit access.