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Safety and Immunogenicity of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase III, Randomized, Blinded,
Hao Zhang1, Yanjun Chen2, Bidan Xu1
1Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China.
Insights
The new Sabin strain-based inactivated polio vaccine (sIPV) is safe and effective in infants, showing lower adverse reactions and strong antibody responses compared to the standard inactivated polio vaccine (wIPV). This Biominhai sIPV offers comparable protection after primary and booster doses.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Clinical Trials
Background:
- The development of safe and immunogenic polio vaccines is crucial for global eradication efforts.
- Sabin strain-based inactivated polio vaccines (sIPV) offer a potential alternative to traditional whole poliovirus vaccines (wIPV).
- Evaluating the safety and immunogenicity of novel vaccine formulations in infant populations is essential.
Purpose of the Study:
- To assess the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine (sIPV) produced by Biominhai.
- To compare the sIPV with a control inactivated polio vaccine (wIPV) in healthy infants.
- To evaluate vaccine performance after both primary immunization and booster doses.
Main Methods:
- A randomized, blinded, positive-controlled phase III clinical trial involving 1200 healthy infants aged 2 months.
- Infants received either sIPV or wIPV at 2, 3, and 4 months of age, with a booster at 18 months.
- Safety (adverse reactions) and immunogenicity (seroconversion rates, antibody titers) were assessed.
Main Results:
- The sIPV group showed significantly lower incidence of adverse reactions like redness and diarrhea after primary immunization compared to wIPV.
- No significant differences in adverse reactions were observed after the booster dose; no serious adverse events were reported for sIPV.
- Seroconversion rates for all three poliovirus types exceeded 98% after primary immunization and remained above 90% after booster in the sIPV group, demonstrating non-inferiority to wIPV.
- Geometric mean titers of neutralizing antibodies were significantly higher in the sIPV group.
Conclusions:
- The Biominhai sIPV demonstrated a favorable safety profile with fewer adverse reactions compared to wIPV after primary immunization.
- The sIPV exhibited robust immunogenicity, achieving high seroconversion rates and antibody titers comparable to or exceeding those of wIPV.
- The sIPV produced by Biominhai is a safe and immunogenic option for infant polio immunization.
Abstract:
Objectives: This randomized, blinded, positive-controlled phase III clinical trial aims to evaluate the safety and immunogenicity of the Sabin strain-based inactivated polio vaccine (sIPV) produced by Biominhai in healthy infants after primary and booster immunization. Methods: A total of 1200 healthy infants, aged 2 months, were randomly assigned to two groups in a 1:1 ratio to receive either one dose of sIPV or the control wIPV at 2, 3, and 4 months of age, followed by a booster dose at 18 months. The safety and immunogenicity of both the primary and the booster immunization were assessed. Results: The incidence of adverse reactions (AEs) was significantly lower in the sIPV group compared to the wIPV group after the primary immunization. Specifically, redness was the most frequently reported AE, occurring in 9% of the sIPV group versus 14% in wIPV (p = 0.01). Diarrhea was also less common in the sIPV group (3%) compared to the wIPV group (8%, p = 0.0004). Moreover, there were no significant differences in incidence, severity, or symptoms of AEs between the groups after the booster immunization. Most AEs were classified as grade 1, and notably, no serious AEs (SAEs) were associated with the trial vaccine. Seroconversion rates for types 1, 2, and 3 poliovirus neutralizing antibodies, in the sIPV group, exceeded 98% at 30 days after primary immunization and remained above 90% at 30 days after booster immunization. Notably, seroconversion rates for all three serotypes following both primary and booster immunizations were non-inferior to those observed in the wIPV group. Additionally, the geometric mean titers (GMTs) of neutralizing antibodies against all types were significantly higher in the sIPV group. Conclusions: The sIPV produced by Biominhai demonstrated comparable safety and immunogenicity to the control vaccine after both primary and booster immunizations.
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