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Updated: Mar 14, 2026
Particle Agglutination Method for Poliovirus Identification
Published on: April 20, 2011
Phase 3 Trial of a Sabin Strain-Based Inactivated Poliovirus Vaccine
Guoyang Liao1, Rongcheng Li2, Changgui Li3
1Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming.
Insights
A new Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) demonstrated comparable immunogenicity and safety to the traditional Salk strain-based IPV. This finding supports Sabin-IPV as a viable option for polio prevention.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Developing countries require effective vaccines against vaccine-associated paralytic poliomyelitis.
- Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) development is crucial for global polio eradication efforts.
Purpose of the Study:
- To compare the immunogenicity and safety of Sabin-IPV against the established Salk strain-based IPV (Salk-IPV).
- To assess the noninferiority of Sabin-IPV in inducing an immune response.
Main Methods:
- A double-blinded, parallel-group, noninferiority trial involving infants aged 60-90 days.
- Random assignment to receive either Sabin-IPV or Salk-IPV (3 doses + booster).
- Assessment of immunogenicity via seroconversion rates and safety through adverse event monitoring.
Main Results:
- High seroconversion rates were observed for both Sabin-IPV (100%, 94.9%, 99.0% for types I, II, III) and Salk-IPV (94.7%, 91.3%, 97.9%).
- Both vaccine types elicited an anamnestic response after a booster dose.
- Adverse events were similar between the two groups, with fever being the only notable difference.
Conclusions:
- Sabin-IPV demonstrated noninferior immunogenicity compared to Salk-IPV.
- The safety profiles of both vaccines were comparable, supporting Sabin-IPV as a safe alternative.
Background:
The development of a Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) is imperative to protecting against vaccine-associated paralytic poliomyelitis in developing countries.
Methods:
In this double-blinded, parallel-group, noninferiority trial, eligible infants aged 60-90 days were randomly assigned in a ratio of 1:1 to receive either 3 doses of Sabin-IPV or Salk strain-based IPV (Salk-IPV) at 30-day intervals and a booster at the age of 18 months. Immunogenicity and safety were assessed on the basis of a protocol.
Results:
Of 1438 infants, 1200 eligible infants were recruited and received either Sabin-IPV or Salk-IPV. From the Sabin-IPV and Salk-IPV groups, 570 and 564 infants, respectively, completed the primary immunization and formed the per-protocol population. The seroconversion rates of the participants who received Sabin-IPV were 100%, 94.9%, and 99.0% (types I, II, and III, respectively), and those of the participants who received Salk-IPV were 94.7%, 91.3%, and 97.9% 1 month after the completion of primary immunization. An anamnestic response for poliovirus types I, II, and III was elicited by a booster in both groups. Except in the case of fever, other adverse events were similar between the 2 groups.
Conclusions:
The immune response induced by Sabin-IPV was not inferior to that established with Salk-IPV.
