Immunogenicity and safety of a dose-sparing inactivated poliovirus vaccine in infants in India: a phase 2/3, double-blind, randomised controlled trial.
Prasad S Kulkarni, Sajjad A Desai, Suman Kanungo et al.
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In 30 seconds
This phase 2/3 randomized controlled trial evaluated the immunogenicity and safety of a dose-sparing inactivated poliovirus vaccine (ds-IPV) in 643 healthy infants in India. The study found that ds-IPV demonstrated non-inferior seroconversion rates compared to the full-dose IPV, with type 1 seroconversion rates of 94.7% for ds-IPV versus 92.8% for IPV, indicating its potential as an alternative vaccination option.
Key findings
- Type 1 poliovirus seroconversion rates were 94.7% for ds-IPV and 92.8% for IPV, with a difference of 1.9.
- Type 2 poliovirus seroconversion rates were 96.3% for ds-IPV and 97.9% for IPV, with a difference of -1.6.
- Type 3 poliovirus seroconversion rates were 97.3% for ds-IPV and 99.0% for IPV, with a difference of -1.6.
- Solicited adverse events were common in both groups, but no serious adverse events were causally related.
Why it matters
The findings suggest that ds-IPV could provide a cost-effective and efficient alternative to the full-dose IPV, potentially improving vaccination coverage in resource-limited settings while maintaining safety and immunogenicity.