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Safety and Immunogenicity of sIPV in Healthy Infants Aged 2 Months Following Sequential Immunization Program
Yafei Liu1, Xiaodong Liu2, Li Zhang2
1Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China.
Insights
The Sabin inactivated poliovirus vaccine (sIPV) demonstrated good safety and immunogenicity in infants. This sequential immunization regimen showed non-inferiority to the control vaccine, indicating its effectiveness.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Poliovirus remains a global public health concern, necessitating effective vaccination strategies.
- Inactivated poliovirus vaccines (IPV) are crucial for polio eradication efforts.
- Sequential immunization schedules combining different vaccine types are being explored to optimize immune responses.
Purpose of the Study:
- To evaluate the safety and immunogenicity of the Sabin inactivated poliovirus vaccine (sIPV) in a sequential immunization regimen.
- To compare the sIPV-based schedule with a whole-cell inactivated poliovirus vaccine (wIPV) schedule in healthy infants.
- To assess antibody responses and adverse events following vaccination.
Main Methods:
- A phase 3 randomized controlled trial involving 300 healthy infants aged 2 months.
- Infants were assigned to either an sIPV-sIPV-bOPV (test) or wIPV-wIPV-bOPV (control) group.
- Safety assessments included monitoring adverse reactions, while immunogenicity was evaluated by measuring poliovirus antibody levels pre- and post-vaccination.
Main Results:
- Both vaccination schedules exhibited comparable safety profiles, with no significant differences in adverse reaction incidence or severity.
- No vaccine-related serious adverse events were reported in either group.
- The sIPV group demonstrated non-inferior seroconversion rates for all poliovirus types and significantly higher geometric mean titers (GMTs) for neutralizing antibodies against poliovirus types I, II, and III compared to the control group.
Conclusions:
- The Sabin inactivated poliovirus vaccine (sIPV) administered via a sequential immunization program is safe and immunogenic in infants.
- The sIPV-based regimen showed non-inferiority to the wIPV-based regimen, suggesting its potential as an effective strategy for polio prevention.
- This study supports the use of sIPV in sequential immunization schedules for achieving robust humoral immunity against poliovirus.
Abstract:
Objectives: This phase 3 clinical trial aimed to evaluate the safety and immunogenicity of the Sabin inactivated poliovirus vaccine (sIPV) manufactured by Biominhai in healthy infants following a sequential immunization regimen. Methods: A total of 300 healthy infants aged 2 months were randomly divided into the test group (sIPV-sIPV-bOPV) and the control group (wIPV-wIPV-bOPV) according to the ratio of 1:1. Both groups were inoculated under "2IPV + 1bOPV" schedule. Safety was assessed alongside poliovirus antibody levels before and after vaccination. Results: The overall incidence of adverse reactions (AEs) in the test and control groups was 44% and 39%, respectively. AEs in both groups primarily occurred following the first dose, with approximately 30% classified as grade 1 in severity. No significant differences were observed between groups regarding the incidence, severity, and symptoms of AEs. Additionally, no vaccine-related serious adverse events (SAEs) were reported. At 30 days after the last dose, the seroconversion rates of neutralizing antibodies against poliovirus types I and III reached 100% in both groups, while type II rates at 99% for the test group and 95% for the control. Notably, the seroconversion rates for all types in the test group were non-inferior to those in the control group. The geometric mean titers (GMTs) of neutralizing antibodies against poliovirus for type I (8622.64 vs. 2687.65), type II (207.73 vs. 54.06), and type III (2121.74 vs. 1699.12) were significantly higher in the test group (p < 0.0001 for type I and II; p = 0.04 for type III). Conclusions: The study concluded that the trial vaccine sIPV following sequential immunization program demonstrates good safety and immunogenicity, showing non-inferiority to the control vaccine.
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