JID：脊髓灰质炎新疫苗DTaP-sIPV安全有效

虽然口服脊髓灰质炎疫苗大大降低了全球感染野生型脊髓灰质炎病毒的人数，但是它可能引起疫苗相关性瘫痪型脊髓灰质炎（VAPP, vaccine-associated paralytic poliomyelitis）和疫苗衍生脊髓灰质炎病毒（VDPVs, vaccine-derived polioviruse）所致的脊髓灰质炎的蔓延。而新的灭活脊髓灰质炎病毒，如减毒的Sabin病毒株（sIPV, inactivated polio vaccine using attenuated Sabin strains），克服了原有口服脊髓灰质炎疫苗的不足之处。在1985年，美国开展了sIPV的Ⅰ期临床试验，评估了sIPV的安全性与有效性。而来自于日本福冈国立医院的Kenji Okada对Kakaetsuken的DTaP-sIPV（diphtheria-tetanus-acellular pertussis vaccine containing inactivated polio vaccine derived from Sabin strains）进行了Ⅱ、Ⅲ期临床研究，评估了其有效性和安全性。研究结果在线发表于2013年4月18日的Journal of Infectious Diseases杂志上，研究显示，DTaP-sIPV是一种安全有效的疫苗。
在研究中，共有104名健康婴儿参与了Ⅱ期临床试验，接受了三种方案的疫苗，方案H是含高剂量sIPV（1、2、3型的剂量分别是3、100、100DU）的DTaP-sIPV，而方案M和L中，sIPV剂量分别是方案H的1/2和1/4。每种方案包括三次基础免疫和一次加强免疫。在Ⅲ期临床试验中，有342名健康婴儿接种了方案H+口服脊髓灰质炎疫苗（OPV）安慰剂或DTaP+OPV。在基础免疫和加强免疫之间口服OPV或OPV安慰剂两次。
结果显示，方案M的剂量最理想。在Ⅲ期研究中，基础免疫后DTaP-sIPV组Sabin病毒血清阳性率达到了100%，并且其加强免疫后的中和抗体滴度比对照组（DTaP+OPV）高。所有的不良反应是临床上可接受的。总之，DTaP-sIPV是一种安全有效的疫苗。

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Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains (DTaP-sIPV)
Background
Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP).
Methods
A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high dose sIPV (3, 100, and 100 D-antigen units (DU) for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered three times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M+oral polio vaccine (OPV) placebo or DTaP+OPV. OPV or OPV placebo was orally administered twice between primary and booster immunizations.
Results
Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP+OPV). All adverse reactions were clinically acceptable.
Conclusions
DTaP-sIPV was shown to be a safe and immunogenic vaccine.