Pneumococcal conjugate vaccination schedules in infants-acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study.
Pneumococcal conjugate vaccination schedules in infants-acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study.
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肺炎球菌偶联疫苗接种时间表在婴儿辅助，免疫原性和肺炎球菌缀合物和黄热病疫苗共同给药研究中。
DOI：
10.1186/s13063-021-05949-4
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发表时间：
2022-01-15
期刊：
影响因子：
2.5
通讯作者：
Mulholland K
中科院分区：
文献类型：
--
作者：
Mackenzie GA;Osei I;Salaudeen R;Secka O;D'Alessandro U;Clarke E;Schmidt-Chanasit J;Licciardi PV;Nguyen C;Greenwood B;Mulholland K
肺炎球菌结合疫苗（PCVs）有效预防肺炎球菌疾病，但肺炎球菌疫苗接种的全球影响受到其成本的阻碍。PCV减剂量方案的评估包括与标准方案相比对免疫原性和载体获得的影响的测量。在冈比亚等中低收入国家，减少剂量计划试验的相关性和可行性最大，在这些国家，PCV的引入带来了良好的疾病控制，但疫苗型肺炎球菌的传播仍然存在。我们设计了一项大型集群随机现场试验，与标准方案（PVS试验）相比，采用另一种减少PCV剂量的方案。我们还将开展一项子研究，以评估这两个时间表对携带获得、免疫原性和PCV与黄热病疫苗联合给药的个体水平影响，即PVS-AcqImm试验。PVS-AcqImm是一项前瞻性、集群随机试验，在6周龄时接种一剂PCV，在9个月时接种加强剂（即替代的“1+1”方案），而在6、10和14周龄时接种三剂主剂量（即标准的“3+0”方案）。替代时间表组内的小组将在9个月大时单独或与PCV联合接种黄热病疫苗。主要终点是(a) 9至14月龄的鼻咽疫苗型肺炎球菌获得率，(b) 18月龄时疫苗型肺炎球菌IgG的几何平均浓度，以及(c)接种黄热病疫苗4周后黄热病中和抗体滴度≥8的比例。参与者和现场工作人员将不会被掩盖分组分配，而实验室终点的测量将被掩盖。28个地理分组（备选和标准日程分组中有14个分组）的常驻人数将大致相等；784人参加采集测量，336人参加免疫原性测量。分析将考虑到群集测量的潜在非独立性，因此对影响的解释将在个体水平（即个体群体）。PVS-AcqImm将评估与标准计划相比，替代计划是否减少了疫苗型肺炎球菌的获得，如果替代计划有效，这是必需的。同样，18个月龄时的优越免疫反应以及PCV与黄热病疫苗联合接种的安全性的证据，将支持有关使用替代性1+1方案的决策。获取和免疫原性结果对于解释比较两个时间表的大型现场试验结果至关重要。国际标准随机对照试验编号72821613。在线版本包含补充材料，可在10.1186/s13063-021-05949-4获得。
Pneumococcal conjugate vaccines (PCVs) effectively prevent pneumococcal disease, but the global impact of pneumococcal vaccination is hampered by its cost. The evaluation of reduced dose schedules of PCV includes measurement of effects on immunogenicity and carriage acquisition compared to standard schedules. The relevance and feasibility of trials of reduced dose schedules is greatest in middle- and low-income countries, such as The Gambia, where the introduction of PCV resulted in good disease control but where transmission of vaccine-type pneumococci persists. We designed a large cluster-randomised field trial of an alternative reduced dose schedule of PCV compared to the standard schedule, the PVS trial. We will also conduct a sub-study to evaluate the individual-level effect of the two schedules on carriage acquisition, immunogenicity, and co-administration of PCV with yellow fever vaccine, the PVS-AcqImm trial. PVS-AcqImm is a prospective, cluster-randomised trial of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. alternative ‘1+1’ schedule) compared to three primary doses scheduled at 6, 10, and 14 weeks of age (i.e. standard ‘3+0’ schedule). Sub-groups within the alternative schedule group will receive yellow fever vaccine separately or co-administered with PCV at 9 months of age. The primary endpoints are (a) rate of nasopharyngeal vaccine-type pneumococcal acquisition from 9 to 14 months of age, (b) geometric mean concentration of vaccine-type pneumococcal IgG at 18 months of age, and (c) proportions with yellow fever neutralising antibody titre ≥8 four weeks after administration of yellow fever vaccine. Participants and field staff will not be masked to group allocation while the measurement of laboratory endpoints will be masked. Approximately equal numbers of participants will be resident in each of 28 geographic clusters (14 clusters in alternative and standard schedule groups); 784 enrolled for acquisition measurements and 336 for immunogenicity measurements. Analysis will account for potential non-independence of measurements by cluster and so interpretation of effects will be at the individual level (i.e. a population of individuals). PVS-AcqImm will evaluate whether acquisition of vaccine-type pneumococci is reduced by the alternative compared to the standard schedule, which is required if the alternative schedule is to be effective. Likewise, evidence of superior immune response at 18 months of age and safety of PCV co-administration with yellow fever vaccine will support decision-making regarding the use of the alternative 1+1 schedule. Acquisition and immunogenicity outcomes will be essential for the interpretation of the results of the large field trial comparing the two schedules. International Standard Randomised Controlled Trial Number 72821613. The online version contains supplementary material available at 10.1186/s13063-021-05949-4.
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影响因子：
168.9
作者：
Cutts, FT;Zaman, SMA;Adegbola, RA
通讯作者：
Adegbola, RA
影响因子：
5.5
作者：
Ota, Martin O.;Akinsola, Adebayo;Adegbola, Richard A.
通讯作者：
Adegbola, Richard A.
影响因子：
56.3
作者：
Mackenzie, Grant A.;Hill, Philip C.;Corrah, Tumani
通讯作者：
Corrah, Tumani
影响因子：
5.5
作者：
Satzke, Catherine;Turner, Paul;O'Brien, Katherine L.
通讯作者：
O'Brien, Katherine L.
影响因子：
56.3
作者：
Mackenzie, Grant A.;Hill, Philip C.;Corrah, Tumani
通讯作者：
Corrah, Tumani