一种脑膜炎球菌结合疫苗与常规扩大免疫接种在非洲婴幼儿中的免疫原性和安全性

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-09-17 DOI:10.1016/j.vaccine.2025.127698

Abraham Hodgson , Fadima Cheick Haidara , Samba O. Sow , Patrick Odum Ansah , Nana Akosua Ansah , Milagritos D. Tapia , Oscar Bangre , Godwin C. Enwere , Simonetta Viviani , Elisa Marchetti , Emanuele Montomoli , Valerio Stanzani , Yuxiao Tang , Brian Plikaytis , Varsha Parulekar , Lionel Martellet , Julie Chaumont , Marie-Françoise Makadi , Prasad S. Kulkarni , George Carlone , Marie-Pierre Preziosi

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引用次数: 0

摘要

2010年，世卫组织对a群脑膜炎球菌结合疫苗进行了资格预审，并在非洲脑膜炎带1-29岁人群的预防运动中推广使用。扩大免疫规划（EPI）的适应症扩大到婴幼儿，以保护新生儿群体。2008年至2012年期间，在加纳进行了一项2期随机对照试验，以评估不同PsA-TT配方（MenA多糖10 μg、5 μg或2.5 μg）在14-18周、9-12个月和12-18个月时与EPI疫苗一起作为一剂或两剂给予的安全性和免疫原性（研究a）。2012年至2013年期间，随后在马里进行了一项3期随机对照试验，以评估在9-12月龄和15-18月龄时，将10 μg和5 μg制剂作为一剂或两剂与扩大免疫疫苗一起接种（研究B）。采用兔补体（rSBA）血清杀菌抗体试验评估免疫原性。研究A表明，5 μg和2.5 μg PsA-TT制剂与10 μg制剂相比无劣效性，每次给药后28天MenA rSBA血清转化率≥93%。在研究B中，在9-12月和15-18月分两次给药以及9-12月单次给药时，在28天MenA rSBA血清转化方面，5 μg与10 μg的非劣效性（≥97%）得到证实。在两项研究的两两比较中证明了大多数EPI抗原的非劣效性。两项研究中接种疫苗后报告的不良事件和严重不良事件在疫苗组之间相似。两项试验的结果都表明，该疫苗与扩大免疫接种联合使用时是安全的和具有免疫原性的，这为世卫组织建议将5 μg PsA-TT作为9-18个月大时的单剂纳入扩大免疫接种铺平了道路。PsA-TT-004，注册国际标准随机对照试验号：ISRCTN82484612；PsA-TT-007，国际注册号：PACTR201110000328305。

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Immunogenicity and safety of a meningococcal a conjugate vaccine administered with routine EPI vaccines in African infants and toddlers

In 2010, a Meningococcal group A (MenA) conjugate vaccine (PsA-TT) was WHO prequalified and introduced in preventive campaigns in 1–29 year-olds across the African Meningitis Belt. An extension of the indication to infants and toddlers in the Expanded Programme on Immunization (EPI) was pursued for the protection of new birth cohorts.

Between 2008 and 2012, a Phase 2 randomized controlled trial was conducted in Ghana to assess the safety and immunogenicity of different PsA-TT formulations (10 μg, 5 μg or 2.5 μg of MenA polysaccharide) given as one or two doses with EPI vaccines at 14–18 weeks, 9–12 months, and 12–18 months of age (Study A). Between 2012 and 2013, a subsequent Phase 3 randomized controlled trial was conducted in Mali to assess the 10 μg and 5 μg formulations given as one or two doses with EPI vaccines at 9–12 and 15–18 months of age (Study B). Immunogenicity was assessed using a serum bactericidal antibody assay using rabbit complement (rSBA).

Non-inferiority of the 5 μg and 2.5 μg PsA-TT formulations to the 10 μg formulation was demonstrated in Study A with ≥93 % seroconversion in MenA rSBA 28 days after each dose. Non-inferiority of the 5 μg to the 10 μg was demonstrated in Study B in terms of seroconversion in MenA rSBA at 28 days (≥97 %) when given as two doses at 9–12 and 15–18 months and as a single dose at 9–12 months. Non-inferiority with respect to most EPI antigens was demonstrated in pairwise comparisons across both studies. Adverse events and serious adverse events reported in either study following vaccinations were similar across vaccine groups.

Results of both trials showed that the vaccine was safe and immunogenic when co-administered with the EPI, paving the way for a WHO recommendation for the 5 μg PsA-TT to be included in the EPI as a single dose at 9–18 months of age.

PsA-TT-004, registered International Standard Randomized Controlled Trial Number: ISRCTN82484612; PsA-TT-007, International registration number: PACTR201110000328305.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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