From the Sanofi, Lyon, France.
Mysore Medical College and Research Institute, Cheluvamba Hospital, Mysore, India.
Pediatr Infect Dis J. 2023 Dec 1;42(12):1128-1135. doi: 10.1097/INF.0000000000004118. Epub 2023 Oct 13.
Antibody persistence of a whole-cell pertussis-containing hexavalent vaccine (DTwP-IPV-HB-PRP~T) and its co- or sequential administration with measles, mumps, rubella (MMR) vaccine were evaluated.
Phase III, open-label, randomized, multicenter study in India. Healthy toddlers 12-24 months of age who had received DTwP-IPV-HB-PRPT or separate DTwP-HB-PRPT+IPV primary vaccination at 6-8, 10-12 and 14-16 weeks of age received a DTwP-IPV-HB-PRP~T booster concomitantly with MMR (N = 336) or 28 days before MMR (N = 340). Participants had received a first dose of measles vaccine. Immunogenicity assessment used validated assays and safety was by parental reports. All analyses were descriptive.
All participants had prebooster anti-T ≥0.01 IU/mL and anti-polio 1 and 3 ≥8 1/dil, and ≥96.5% had anti-D ≥0.01 IU/mL, anti-HBs ≥10 mIU/mL, anti-polio 2 ≥8 1/dil and anti-PRP ≥0.15 µg/mL; for pertussis, antibody persistence was similar in each group. Postbooster immunogenicity for DTwP-IPV-HB-PRPT was similar for each antigen in each group: ≥99.5% of participants had anti-D ≥0.01 IU/mL, anti-T ≥0.01 IU/mL, anti-polio 1, 2 and 3 >8 1/dil, anti-HBs ≥10 mIU/mL and anti-PRP ≥1 µg/mL; for pertussis, vaccine response was similar in each group [72.0%-75.9% (anti-PT), 80.8%-81.4% (anti-FIM), 77.6%-79.5% (anti-PRN), 78.2%-80.8% (anti-FHA)]. There was no difference in MMR immunogenicity between groups, and no difference in DTwP-IPV-HB-PRPT booster immunogenicity based on the primary series. There were no safety concerns.
DTwP-IPV-HB-PRPT antibody persistence was similar to licensed comparators. Booster immunogenicity was robust after DTwP-IPV-HB-PRPT with or without MMR, and MMR immunogenicity was not affected by coadministration with DTwP-IPV-HB-PRP~T.
CTRI/2020/04/024843.
评估全细胞百日咳含ipv 六价疫苗（DTwP-IPV-HB-PRP~T）的抗体持久性及其与麻疹、腮腺炎、风疹（MMR）疫苗的共同或序贯给药。
在印度进行的 III 期、开放标签、随机、多中心研究。12-24 月龄的健康幼儿，在 6-8、10-12 和 14-16 周龄时已接受 DTwP-IPV-HB-PRPT 或单独的 DTwP-HB-PRPT+IPV 基础免疫，随后与 MMR（N=336）同时或在 MMR 前 28 天（N=340）接受 DTwP-IPV-HB-PRP~T 加强免疫。参与者已接受了第一剂麻疹疫苗。使用经过验证的检测方法评估免疫原性，安全性由家长报告。所有分析均为描述性。
所有参与者均有预加强抗-T≥0.01 IU/mL 和抗脊灰 1 和 3≥8 1/dil，且≥96.5%有抗-D≥0.01 IU/mL、抗-HBs≥10 mIU/mL、抗脊灰 2≥8 1/dil 和抗-PRP≥0.15 µg/mL；对于百日咳，各组的抗体持久性相似。各组 DTwP-IPV-HB-PRPT 加强免疫后的免疫原性对于每个抗原均相似：≥99.5%的参与者有抗-D≥0.01 IU/mL、抗-T≥0.01 IU/mL、抗脊灰 1、2 和 3>8 1/dil、抗-HBs≥10 mIU/mL 和抗-PRP≥1 µg/mL；对于百日咳，各组的疫苗反应相似[抗-PT72.0%-75.9%（抗-PT）、抗-FIM80.8%-81.4%、抗-PRN77.6%-79.5%、抗-FHA78.2%-80.8%]。各组之间 MMR 免疫原性无差异，并且根据基础系列，DTwP-IPV-HB-PRPT 加强免疫的 DTwP-IPV-HB-PRP~T 免疫原性无差异。无安全性问题。
DTwP-IPV-HB-PRPT 的抗体持久性与许可的对照相似。在 DTwP-IPV-HB-PRPT 后进行加强免疫时，无论是与 MMR 同时给药还是序贯给药，其免疫原性均很强，并且 MMR 免疫原性不受与 DTwP-IPV-HB-PRP~T 共同给药的影响。
CTRI/2020/04/024843。
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