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A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated

Rong Tang1, Guifan Li2, Chengfu Zhang3

  • 1Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province) , Jiangsu, China.

Human Vaccines & Immunotherapeutics
|April 30, 2020
PubMed

Insights

This study found that experimental Sabin inactivated poliovirus vaccines (IPV) with varying D antigen content demonstrated good safety and immunogenicity in infants. While more reactogenic than controls, they showed promising results for polio prevention.

Area of Science:

  • Vaccinology
  • Immunology
  • Pediatric Infectious Diseases

Background:

  • Poliovirus vaccines are crucial for global polio eradication efforts.
  • Sabin-strain inactivated poliovirus vaccines (IPV) offer an alternative to Salk-strain IPV.
  • Evaluating the safety and immunogenicity of novel IPV formulations is essential.

Purpose of the Study:

  • To assess the safety and immunogenicity of experimental Sabin IPV preparations with varying D antigen content.
  • To compare these experimental vaccines against control Sabin IPV and Salk IPV in infants.

Main Methods:

  • A phase II, randomized, controlled trial involving 600 infants aged 60-90 days.
  • Infants received one of five IPV preparations (three experimental Sabin IPVs, one control Sabin IPV, one control Salk IPV) on a 0-1-2 month schedule.
  • Safety was monitored via observation and follow-up; immunogenicity was assessed by serum antibody titers before and after vaccination.

Main Results:

  • All experimental Sabin IPV groups showed high seroconversion rates for poliovirus types 1, 2, and 3, comparable to control groups.
  • Injection site reactions (redness, swelling, pain) were significantly higher in experimental vaccine groups compared to controls.
  • No serious adverse events related to vaccination were detected; most reactions were mild to moderate.

Conclusions:

  • Experimental Sabin IPVs with low, medium, and high D antigen content exhibit favorable safety and immunogenicity profiles.
  • These novel IPV formulations are potential candidates for future polio immunization strategies.
  • Further studies may be warranted to optimize reactogenicity while maintaining efficacy.

Keywords:
Inactivated poliovirus vaccineSabin strainimmunogenicityphase Ⅱ trialsafety

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