在印度健康婴儿中，接种六价 DTwP-IPV-HB-PRP~T 疫苗与分别接种 DTwP-HB-PRP~T 和 IPV 疫苗相比，抗体持久性和安全性以及接种 MMR 疫苗加强剂量 DTwP-IPV-HB-PRP~T 的免疫原性。
Antibody Persistence Following Administration of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T and IPV Vaccines and Safety and Immunogenicity of a Booster Dose of DTwP-IPV-HB-PRP~T Administered With an MMR Vaccine in Healthy Infants in India.
机构信息
From the Sanofi, Lyon, France.
Mysore Medical College and Research Institute, Cheluvamba Hospital, Mysore, India.
出版信息
Pediatr Infect Dis J. 2023 Dec 1;42(12):1128-1135. doi: 10.1097/INF.0000000000004118. Epub 2023 Oct 13.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
CLINICAL TRIALS REGISTRY INDIA NUMBER
CTRI/2020/04/024843.
背景
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。
方法
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。
结果
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。
结论
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。
临床试验印度注册号
CTRI/2020/04/024843。
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