Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on finding the best ways to improve the effectiveness of a new oral polio vaccine called nOPV2. Researchers want to test two different strategies: one is giving another type of vaccine (IPV) after the nOPV2 and another oral vaccine (bOPV) to boost immunity, and the other is spacing out the two vaccines by four weeks to see if that helps. The study will involve healthy infants who are 6 weeks old, with a total of 880 participants. Blood samples will be taken from the babies to check their immunity against polio.

To participate, infants must be healthy and 6 weeks old, and their parents need to agree to take part in the study and understand what it involves. Some infants may not be eligible if they have certain medical conditions or if they have received any polio vaccines before. The trial is not yet recruiting participants, but once it starts, it aims to gather important information on how effective these vaccination strategies are in protecting against polio.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy infants 6 weeks of age
• • 2. Parents that consent for participation in the full length of the study.
• • 3. Parents that can understand and comply with planned study procedures.
• Exclusion Criteria:
• • 1. Parents and infants are unable to participate in the full length of the study
• • 2. A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• • 3. A diagnosis or suspicion of bleeding disorder
• • 4. Acute diarrhoea, infection, or illness at the time of enrolment
• • 5. Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
• • 6. Evidence of a chronic medical condition
• • 7. Receipt of any polio vaccine (OPV or IPV) before enrolment
• • 8. Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• • 9. Infants from multiple births.
• • 10. Infants from premature births (\<37 weeks of gestation).