Oxford Vaccine Group, University of Oxford, Oxford, UK.
NIHR Oxford Biomedical Research Centre, Oxford, UK.
Trials. 2023 Jul 21;24(1):465. doi: 10.1186/s13063-023-07477-9.
Universal immunisation is the cornerstone of preventive medicine for children, The World Health Organisation (WHO) recommends diphtheria-tetanus-pertussis (DTP) vaccine administered at 6, 10 and 14 weeks of age as part of routine immunisation. However, globally, more than 17 unique DTP-containing vaccine schedules are in use. New vaccines for other diseases continue to be introduced into the infant immunisation schedule, resulting in an increasingly crowded schedule. The OptImms trial will assess whether antibody titres against pertussis and other antigens in childhood can be maintained whilst adjusting the current Expanded Programme on Immunisation (EPI) schedule to provide space for the introduction of new vaccines.
The OptImms studies are two randomised, five-arm, non-inferiority clinical trials in Nepal and Uganda. Infants aged 6 weeks will be randomised to one of five primary vaccination schedules based on age at first DTwP-vaccination (6 versus 8 weeks of age), number of doses in the DTwP priming series (two versus three), and spacing of priming series vaccinations (4 versus 8 weeks). Additionally, participants will be randomised to receive their DTwP booster at 9 or 12 months of age. A further sub-study will compare the co-administration of typhoid vaccine with other routine vaccines at one year of age. The primary outcome is anti-pertussis toxin IgG antibodies measured at the time of the booster dose. Secondary outcomes include antibodies against other vaccine antigens in the primary schedule and their safety.
These data will provide key data to inform policy decisions on streamlining vaccination schedules in childhood.
ISRCTN12240140 (Nepa1, 7 January 2021) and ISRCTN6036654 (Uganda, 17 February 2021).
儿童预防医学的基石是全民免疫。世界卫生组织（WHO）建议在 6、10 和 14 周龄时使用白喉-破伤风-百日咳（DTP）疫苗作为常规免疫的一部分。然而，在全球范围内，有超过 17 种独特的含 DTP 疫苗接种时间表正在使用。针对其他疾病的新疫苗不断被引入婴儿免疫接种计划，导致日程安排越来越拥挤。OptImm 试验将评估在调整当前扩大免疫规划（EPI）时间表以留出空间引入新疫苗的同时，能否维持儿童体内针对百日咳和其他抗原的抗体滴度。
OptImm 研究是在尼泊尔和乌干达进行的两项随机、五组、非劣效性临床试验。6 周龄的婴儿将根据首次 DTwP 疫苗接种的年龄（6 周或 8 周）、DTwP 初免系列的剂量数（2 剂或 3 剂）以及初免系列疫苗接种的间隔（4 周或 8 周）随机分配至五种主要接种时间表之一。此外，参与者还将随机接受 DTwP 加强针在 9 或 12 个月龄时接种。一项子研究将比较在 1 岁时同时接种伤寒疫苗和其他常规疫苗的效果。主要结局是在加强针接种时测量抗百日咳毒素 IgG 抗体。次要结局包括初级计划中针对其他疫苗抗原的抗体及其安全性。
这些数据将为优化儿童疫苗接种计划的决策提供关键数据。
ISRCTN81371746（Nepa1，2021 年 1 月 7 日）和 ISRCTN6036654（乌干达，2021 年 2 月 17 日）。
