Kawade Anand, Dayma Girish, Apte Aditi, Telang Nilima, Satpute Meenakshi, Pearce Emma, Roalfe Lucy, Patil Rakesh, Wang Yanyun, Noori Navideh, Gondhali Arun, Juvekar Sanjay, Oron Assaf P, Sanghavi Sonali, Goldblatt David, Dagan Ron, Bavdekar Ashish
Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Vadu Rural Health Program, KEM Hospital Research Centre, Pune, India.
Vaccine. 2023 May 5;41(19):3066-3079. doi: 10.1016/j.vaccine.2023.04.008. Epub 2023 Apr 10.
This study aimed to assess the effect of a reduced dose regime (1 + 1) of PCV10 and PCV13 along with 3-dose regimes on pneumococcal vaccine-type (VT) carriage and immunogenicity in the first two years of life in PCV-naïve Indian children.
A total of 805 healthy infants aged 6-8 weeks were randomised to 7 groups (n = 115). Six groups received Synflorix(PCV10) or Prevenar13(PCV13) in the following schedules: 3 + 0 (three primary at 6, 10, and 14 weeks); 2 + 1 (two primary 6 and 14 weeks with booster at 9 months; 1 + 1 (one primary at 14 weeks with booster at 9 months). The 7th group was a PCV-naïve control group. Nasopharyngeal swabs were collected at 6, 18 weeks, 9, 10, 15, and 18 months of age. Venous blood samples were collected at 18 weeks, 9, 10, and 18 months of age for assessment of sero-specific IgG antibodies. Additionally, functional activity using a serotype specific opsonophagocytic assay (OPA) was assessed at 10 and 18 months of age in a subset (20%) of participants.
All schedules of PCV13 showed significant 13VT carriage reduction in the second year of life as compared to control. At 15 months of age, PCV13 (1 + 1) showed 45 % reduction in 13VT-carriage compared to the control [OR = 0.55 (95% CI; 0.31-0.97), p= 0.038]. None of the PCV10 schedules showed significant reduction in 10VT carriage in the second year. Although not powered for these outcomes, at 18 months of age, 1 + 1 and 2 + 1 schedules of both vaccines demonstrated higher sero-responders for all serotypes, higher geometric mean concentrations (GMC) for all serotypes except 23F [with both vaccines], higher percent OPA responders and OPA geometric mean titres (GMT) compared to the 3 + 0 schedules for all serotypes.
The reduced dose schedule (1 + 1) of PCV13 results in significant VT-carriage reduction in the second year of life. Immune protection provided by 1 + 1 schedules of PCV10 and PCV13 in the second year of life is comparable to WHO-recommended 3-dose schedules.
本研究旨在评估在未接种过肺炎球菌疫苗的印度儿童出生后的头两年中，1+1的PCV10和PCV13减量接种方案以及3剂接种方案对肺炎球菌疫苗血清型（VT）携带率和免疫原性的影响。
总共805名6-8周龄的健康婴儿被随机分为7组（每组n = 115）。6组婴儿按照以下接种程序接种Synflorix（PCV10）或Prevenar13（PCV13）：3+0（在6、10和14周时接种3剂基础疫苗）；2+1（在6周和14周时接种2剂基础疫苗，在9个月时接种加强针）；1+1（在14周时接种1剂基础疫苗，在9个月时接种加强针）。第7组为未接种肺炎球菌疫苗的对照组。在婴儿6、18周龄以及9、10、15和18月龄时采集鼻咽拭子。在18周龄以及9、10和18月龄时采集静脉血样，以评估血清特异性IgG抗体。此外，在10和18月龄时，对部分（20%）参与者进行血清型特异性吞噬调理活性测定（OPA）以评估功能活性。
与对照组相比，所有PCV13接种程序在儿童出生后第二年均显著降低了13VT携带率。在15月龄时，PCV13（1+1）接种程序的13VT携带率相比对照组降低了45%[比值比（OR）=0.55（95%置信区间；0.31-0.97），p = 0.038]。没有一种PCV10接种程序在第二年显著降低10VT携带率。尽管未针对这些结果进行功效分析，但在18月龄时，两种疫苗的1+1和2+1接种程序与所有血清型的3+0接种程序相比，均显示出所有血清型的血清反应者比例更高、除23F外（两种疫苗均如此）所有血清型的几何平均浓度（GMC）更高、OPA反应者百分比更高以及OPA几何平均滴度（GMT）更高。
PCV13的减量接种程序（1+1）在儿童出生后第二年可显著降低VT携带率。PCV10和PCV13的1+1接种程序在儿童出生后第二年提供的免疫保护与世界卫生组织推荐的3剂接种程序相当。
