Zydus Cadila Announces Completion of Dosing in Phase I Clinical Trial of ZyCoV-D
Ahmedabad, August 05, 2020
? Safety in Phase I clinical trial of ZyCoV-D in healthy subjects established as endorsed by
the independent Data Safety Monitoring Board (DSMB).
? Zydus to commence Phase II trial on the 6
th of August, 2020
Zydus Cadila, an innovation driven global pharmaceutical company focused on discovering
and developing NCEs, Novel Biologicals, Biosimilars and Vaccines, today announced that 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
6
th of August, 2020.
The Company reports that 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. Previously, the
vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity
studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.
?The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,? said
Mr. 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.?
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 Phase II study of ZyCoV-D
will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose
escalation, multicentric, randomized, double-blind placebo controlled study.
With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the
country using non-replicating and non-integrating plasmid carrying the gene of interest making
it very safe. Further, no vector response and with absence of any infectious agent, 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 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. Zydus acknowledges the support of National Biopharma Mission, BIRAC,
Department of Biotechnology, Govt of India in the development of ZyCoV-D.
Zydus? Vaccine research programme
Vaccine Technology Centre of Zydus Cadila has wide range of capabilities in developing and
manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet
needs. In fact, Zydus was the first company in India to develop and indigenously manufacture
the vaccine to combat Swine Flu during the pandemic in 2010. In past, it has also indigenously
developed numerous vaccines successfully including tetravalent seasonal influenza vaccine
(first company in India to indigenously develop and commercialize), Inactivated Rabies
vaccine (WHO Prequalified), Varicella vaccine (first Indian company to indigenously develop
and receive market authorization), Measles containing vaccines (MR, MMR, Measles),
Typhoid conjugate vaccine, pentavalent vaccine (DPT-HepB-Hib) etc to name a few. The
company also has a strong pipeline of vaccines like Measles-Mumps-Rubella-Varicella
(MMRV), Human papillomavirus vaccine, Hepatitis A, Hepatitis E vaccines which are at
various stages of development.
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