School of Child and Adolescent Health and Institute of Infectious Disease and Molecular Medicine, Medicine, University of Cape Town, Cape Town, South Africa.
J Infect Dis. 2012 Jan 15;205(2):228-36. doi: 10.1093/infdis/jir721. Epub 2011 Dec 8.
The Global Polio Eradication Initiative aims to eradicate wild poliovirus by the end of 2012. Therefore, more-immunogenic polio vaccines, including monovalent oral poliovirus vaccines (mOPVs), are needed for supplemental immunization activities. This trial assessed the immunogenicity of monovalent types 1 and 3, compared with that of trivalent oral poliovirus vaccine (tOPV), in South Africa.
We conducted a blinded, randomized, 4-arm controlled trial comparing the immunogenicity of a single dose of mOPV1 (from 2 manufacturers) and mOPV3 (from 1 manufacturer), given at birth, with the immunogenicity of tOPV.
Eight hundred newborns were enrolled; 762 (95%) were included in the analysis. At 30 days after vaccine administration, seroconversion to poliovirus type 1 was 73.4% and 76.4% in the 2 mOPV1 arms, compared with 39.1% in the tOPV arm (P < .0000001), and seroconversion to poliovirus type 3 was 58.0% in the mOPV3 arm, compared with 21.2% in the tOPV arm (P < .0000001). The vaccines were well tolerated, and no adverse events were attributed to trial interventions.
A dose of mOPV1 or mOPV3 at birth was superior to that of tOPV in inducing type-specific seroconversion in this sub-Saharan African population. Our results support continued use of mOPVs in supplemental immunization activities in countries where poliovirus types 1 or 3 circulate. Clinical Trials Registration. ISRCTN18107202.
全球消灭脊灰行动旨在 2012 年底消灭野生脊灰病毒。因此，需要更具免疫原性的脊灰疫苗，包括单价口服脊灰疫苗（mOPV），用于补充免疫活动。本试验评估了单价 1 型和 3 型疫苗（来自 2 家制造商）与三价口服脊灰疫苗（tOPV）在南非的免疫原性。
我们进行了一项盲法、随机、4 臂对照试验，比较了单剂 mOPV1（来自 2 家制造商）和 mOPV3（来自 1 家制造商）与 tOPV 的免疫原性。
共纳入 800 名新生儿；762 名（95%）纳入分析。疫苗接种后 30 天，血清型 1 脊灰病毒的血清转化率在 2 个 mOPV1 组分别为 73.4%和 76.4%，tOPV 组为 39.1%（P <.0000001），血清型 3 脊灰病毒的血清转化率在 mOPV3 组为 58.0%，tOPV 组为 21.2%（P <.0000001）。疫苗耐受性良好，没有与试验干预相关的不良事件。
在撒哈拉以南非洲人群中，mOPV1 或 mOPV3 的一剂剂量在诱导针对特定类型的血清转化率方面优于 tOPV。我们的结果支持在脊灰病毒 1 型或 3 型流行的国家继续使用 mOPV 进行补充免疫活动。临床试验注册。ISRCTN842202。
