Abstract

Objective To evaluate the immunogenicity and sustainability of different doses Sabin strain inactivated poliovirus vaccine (sIPV) in different preparations of DTaP-sIPV. Methods DTaP-sIPV with high or low dose sIPV was produced using 2 fomulations. Seventy rats were simply randomized into 7 groups (10 per group), which were F1H (DTaP-sIPV high dose, formulation 1), F2H (DTaP-sIPV high dose, formulation 2), sIPV-H (sIPV high dose), F1L (DTaP-sIPV low dose, formulation 1), F2L (DTaP-sIPV low dose, formulation 2), sIPV-L (sIPV low dose), and Sanofi Pasteur pentavalent vaccine PENTAXIM control group. Animals were immunized intramuscularly with 0.5 ml vaccine on hind limbs at 0, 3, and 6 week. Blood was drawn from eyes at 0, 3, 6, 9, 13, 17, 21, and 25 week. The titers of neutralizing antibodies against 3 types of poliovirus (PV) were determined by microcytopathic effect inhibition assay. Results The neutralizing antibodies against PV1, PV2, and PV3 continuously increased after each immunization to reach peak at 9 week, then decreased significantly from 13 week but retained relatively high levels up to 25 week. Comparing the geometric mean titers (GMT) of neutralizing antibodies in 7 groups, 3 weeks after 3 injections, anti-PV1 in F2H group was significantly higher than in PENTAXIM group (F=0.988, P=0.027); anti-PV2 in F2H group was higher than in F1H group, in sIPV-H group was higher than in F1H and PENTAXIM groups (F=2.391, all P<0.05); anti-PV3 showed no significant difference among all groups. The neutralizing antibodies against all 3 PV in F2H group after 3 immunizations were the highest at every point, but only anti-PV2 at 6 week reached statistical significance over F1H group. Conclusions DTaP-sIPV immunization can induce neutralizing antibodies against all 3 PV in rats. The immunogenicity and sustaining time are no less than PENTAXIM. The GMT in DTaP-sIPV is no less than sIPV at same dose. The 2 preparations have no statistically significant effect on the immunogenicity of sIPV in DTaP-sIPV, though formulation 2 may be more preferred. Key words: Poliovirus vaccine, inactivated; Diphtheria-tetanus-acellular pertussis vaccines; Antibodies, neutralizing; Immunogenicity

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