A Comparison of Safety and Immunogenicity of Rabies Pre Exposure Prophylaxis Regimen Between Gvt of India Approved and WHO Approved.

Launched by KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is examining two different schedules for rabies vaccination to see which one is safer and more effective at helping the body build protection against the virus. One schedule follows the recommendations of the World Health Organization (WHO), which involves two doses of the vaccine given at different sites on days 0 and 7. The other schedule is the one currently used by the Government of India, which includes three smaller doses on days 0, 7, and 28. The trial is open to healthy volunteers aged 18 and older who can commit to follow-up visits after vaccination.

Participants will receive a rabies vaccine that has been approved by the WHO and will be monitored for any side effects, as well as for how well their bodies respond to the vaccine over the following months. To join the study, individuals must not have received a rabies vaccine or related treatment in the past, should be in good health, and not be pregnant or breastfeeding. This research aims to ensure that the best vaccination approach is used to protect against rabies effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy subjects willing to volunteer and sign written informed consent for the study.
• • Subjects should be available for the follow-up period.
• Exclusion Criteria:
• • Received Anti rabies vaccine or RIG or RMAb anytime in the past.
• • Participation in any other clinical trial in the past three months.
• • Severely immunocompromised subjects, pregnant and lactating women.
• • Subjects with known history of allergy.