Zydus Cadila (Cadila Healthcare Limited) published the results from their Phase I clinical study evaluating the safety and immunogenicity of their COVID-19 DNA vaccine, delivered using the PharmaJet Tropis Needle-free Injection System. The ZyCoV-D vaccine is comprised of plasmid DNA carrying the spike gene from SARS-CoV-2 and was initially evaluated in mouse, guinea pig, and rabbit models and shown to be immunogenic and promising for clinical studies.
43 healthy volunteers completed the single-center Phase I study. The results showed that three 2mg doses of ZyCoV-D delivered intradermally with Tropis elicited good humoral and cellular immune responses to the vaccine. The data also demonstrates that ZyCoV-D has a good safety profile and was well tolerated after the second and third doses, indicating that the vaccine could be a safe booster as there was no increase in side effects after multiple doses.
The publication also highlights the benefits of needle-free injection, including ease of administration, reliability, and precision. While the subsequent Phase II and III data is awaiting publication, ZyCoV-D has recently been awarded Emergency Use Authorization by the Drug Controller General of India (DCGI).
To learn more, please refer to the full study, which was published in eClinicalMedicine on July 17, 2021.