According to a 48-person phase I study published ahead of print in the Lancet’s EClinicalMedicine journal, the DNA vaccine produced by Indian pharmaceutical company Zydus Cadila was shown to be safe and immunogenic. The three-dose vaccination was shown to induce excellent antibody and cellular protection, according to the research, and no vaccine-related serious side events were recorded.
The phase I trial, however, had no women participants.
The 48 participants were divided into four study arms study two different doses and two different methods of vaccine administration; arm 1 received 1mg dose of the vaccine using needle, arm 2 received 1 mg vaccine intradermally, arm 3 received 2 mg vaccine with needle, and arm 4 received 2 mg vaccine intradermally.
None of the 48 participants experienced any serious adverse events. However, at least 12 participants reported an adverse event. The “solicited” adverse events that were seen in seven of the participants were mild fever, itching, joint pain, tenderness of injection site, and moderate diarrhoea. Most of the events were reported after the administration of the first dose of the vaccine
