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Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial
Yuemei Hu1, Jianfeng Wang2, Gang Zeng3
1Department of Vaccine Evaluation, Nanjing.
Insights
The Sabin strain-based inactivated polio vaccine (sIPV) is as effective as the traditional IPV in infants. This study confirms sIPV
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Public Health
Background:
- Poliomyelitis eradication efforts are ongoing globally.
- The Sabin strain-based inactivated polio vaccine (sIPV) is crucial for polio elimination in developing nations.
Purpose of the Study:
- To evaluate the immunogenicity and safety of the sIPV compared to the conventional inactivated polio vaccine (IPV).
Main Methods:
- A randomized, controlled, double-blinded, noninferiority trial involving 1200 infants aged 60-90 days.
- Infants received three doses of either sIPV or IPV at 0, 30, and 60 days.
- Immunogenicity (seroconversion rates) and safety (adverse events) were assessed.
Main Results:
- sIPV demonstrated noninferior seroconversion rates for poliovirus types 1 (98.0% vs 94.1%) and 2 (94.8% vs 84.0%) compared to IPV (P < .01).
- Seroconversion for type 3 was high in both groups (98.9% vs 97.7%).
- Fever was more common in the sIPV group (61.6% vs 49.8%, P < .01), but overall safety was good.
Conclusions:
- The sIPV exhibits an immunogenicity profile that is noninferior to the conventional IPV.
- sIPV demonstrates a favorable safety profile, supporting its use in infant immunization programs.
Background:
The Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries.
Methods:
The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60-90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively.
Results:
A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P < .01); 94.8% and 84.0%, respectively, for type 2 (P < .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P < .01).
Conclusions:
The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile.
Clinical Trials Registration:
NCT03526978.
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