Investigator(s)
| WHO Technical Officer |
Mohammad Ahmad WCO India- Research Mohammad Ahmad 
|
| Principal Investigator |
Dr Shailesh Pawar Indian Council of Medical Research- National Institute of Virology (ICMR-NIV, Pune) Dr Shailesh Pawar
|
Title(s) and abstract
| Scientific title | “Comparative evaluation of immunogenicity of variable dose schedules of Inactivated Poliovirus Vaccine in routine immunization: A multi-centric open label randomized controlled trial” |
| Public title | India f-IPV study-2024 |
| Background | As per the SAGE recommendations, India introduced two fractional doses of IPV (fIPV) 0.1 ml intradermal. However, two early fIPV dose schedule provide only about 79% seroconversion. To close this immunity gap, possibly a full or fractional dose of IPV at 9-12 months added to the currently practiced two fIPV schedule. With this background and based on the recommendations of India Expert Advisory Group (IEAG) on Polio eradication and approval (technical and funding) from the Polio Research Committee (PRC, Geneva), we propose to conduct a randomized controlled trial on Indian infants to assess the gains in immunity provided by the third dose (fractional/full) over and above the existing two fIPV schedule. This trial was proposed before the Covid-19 p[pandemic and was submitted to WHO ERC (before SEAR EC was constituted) and approved by it. Due to the delay from Pandemic and later Biennium Closure issues, the implementation is delayed, and we hope to initiate the trial in 2025 after obtaining National Regulatory |
| Objectives | Primary objective: 1.Compare the gains in seroconversion and antibody titres after third IPV dose, fractional or full. Secondary objective: 1. Assess persistence of serotype 2antibodies after two fIPV dose schedule 2. Assess persistence of priming following two fIPV doses |
| Study Methods | The study is two arm, multicentric, open label, RCT. Study will be implemented at four research sites proposed in different parts of India. India is a large country with different cultures and shall be implemented as per the attached protocol among infants 9-12 months old infants coming to study sites for first the MR vaccine in the routine immunization schedule. |
| Expected outcomes and use of results | The data generated will help India to take an informed decision on future immunization schedule as well as be very useful for other countries using fIPV or potentially adopting best fIPV schedule in future as a cost saving and antigen sparing option. It will be beneficial for countries and GPEI to achieve higher and durable protection in the populations in the short/medium/long term at a much lower cost. |
| Keywords | India fIPV Trial Schedule |
Research Details
| Student research | No |
| Start Date | 01-Dec-2024 |
| End Date | 31-Dec-2025 |
| Key Implementing Institution | Indian Council of Medical Research- National Institute of Virology (ICMR-NIV, Pune) |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Immunization/Vaccine Preventable Disease |
| Involves human subjects | Yes |
| Clinical Trial with Human Subjects | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |