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

ABSTRACT:

Background

Pertussis, diphtheria, tetanus, poliomyelitis, and Haemophilus influenzae type b (Hib) infections pose severe threats to children's health globally. This study evaluated the safety and immunogenicity of a novel Sabin strain-based adsorbed pentavalent vaccine (DTacP-sIPV/Hib), which offers potential advantages in biosafety and cost-effectiveness compared to wild-type poliovirus-based vaccines.

Methods

A repeated-dose toxicity study was conducted in 190 Sprague-Dawley rats, randomly divided into negative control, adjuvant control, low-dose, and high-dose groups. Animals received five intramuscular injections at 21-day intervals, followed by a 56-day recovery period. Parameters assessed included local reactions, body temperature, hematology, serum biochemistry

SUBMITTER: Zhao T 

PROVIDER: S-EPMC12846469 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature