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Preclinical Study on Sabin Strain-Based DTaP-sIPV/Hib Pentavalent Vaccine: Evaluation of Repeated-Dose Toxicity and

Ting Zhao1,2,3, Han Chu1, Yan Ma1,2,3

  • 1Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming 650118, China.

Vaccines
|January 28, 2026
PubMed

Insights

This study shows a new pentavalent vaccine (DTacP-sIPV/Hib) is safe and effective in rats. It protects against diphtheria, tetanus, pertussis, polio, and Hib infections, offering a promising option for global immunization.

Area of Science:

  • Vaccinology
  • Immunology
  • Toxicology

Background:

  • Global threats from childhood infectious diseases like pertussis, diphtheria, tetanus, poliomyelitis, and Hib infections.
  • Evaluation of a novel Sabin strain-based pentavalent vaccine (DTacP-sIPV/Hib) for improved biosafety and cost-effectiveness.

Purpose of the Study:

  • To assess the safety and immunogenicity of the DTacP-sIPV/Hib vaccine in a rat model.
  • To compare the novel Sabin strain-based vaccine with traditional wild-type poliovirus vaccines.

Main Methods:

  • A repeated-dose toxicity study in 190 Sprague-Dawley rats across different dose groups.
  • Assessment of local reactions, body temperature, hematology, biochemistry, histopathology, immune cell subsets, cytokine levels, and immunogenicity over 56 days post-injection.

Main Results:

  • Dose-dependent, reversible local muscle swelling was the primary adverse reaction.
  • Transient, resolving body temperature fluctuations and adjuvant-related hematological/biochemical changes were observed.
  • 100% seroconversion for bacterial components and poliovirus serotypes was achieved, demonstrating robust immunogenicity.

Conclusions:

  • The DTacP-sIPV/Hib vaccine demonstrated a favorable safety profile and strong immunogenicity in rats.
  • Sabin strain utilization reduces biosafety risks and manufacturing costs, positioning the vaccine for clinical development.
  • This pentavalent vaccine is a promising candidate for global immunization programs, particularly in resource-limited settings.
Abstract

Keywords:
DTacP-sIPV/Hib pentavalent vaccineSabin inactivated poliovirus vaccine (Sabin IPV)repeated-dose toxicity

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