The DNA vaccine, developed by Indian pharmaceutical company Zydus Cadila, has been found to be safe and immunogenic, according to the 48-participant phase I trial published ahead of print on EClinicalMedicine journal by Lancet. There were no vaccine-related severe adverse events reported and the three-dose vaccine was found to generate good antibody and cellular immunity, the study said.
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