Background

To optimize vaccine implementation visits for young children, it could be efficient to administer the first RTS,S/AS01 malaria vaccine dose during the Expanded Programme on Immunization (EPI) visit at 6 months of age together with Vitamin A supplementation and the third RTS,S/AS01 dose on the same day as yellow fever (YF), measles and rubella vaccines at 9 months of age. We evaluated the safety and immunogenicity of RTS,S/AS01 when co-administered with YF and combined measles-rubella (MR) vaccines.

Methods

In this phase 3b, open-label, controlled study (NCT02699099), 709 Ghanaian children were randomized (1:1:1) to receive RTS,S/AS01 at 6, 7.5 and 9 months of age, and YF and MR vaccines at 9 or 10.5 months of age (RTS,S coad and RTS,S alone groups, respectively). The third group received YF and MR vaccines at 9 months of age and will receive RTS,S/AS01 at 10.5, 11.5 and 12.5 months of age (Control group). All children received Vitamin A at 6 months of age. Non-inferiority of immune responses to the vaccine antigens was evaluated 1 month following co-administration versus RTS,S/AS01 or EPI vaccines (YF and MR vaccines) alone using pre-defined non-inferiority criteria. Safety was assessed until Study month 4.5.

Results

Non-inferiority of antibody responses to the anti-circumsporozoite and anti-hepatitis B virus surface antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus RTS,S/AS01 alone was demonstrated. Non-inferiority of antibody responses to the measles, rubella, and YF antigens when RTS,S/AS01 was co-administered with YF and MR vaccines versus YF and MR vaccines alone was demonstrated. The safety profile of all vaccines was clinically acceptable in all groups.

Conclusions

RTS,S/AS01 can be co-administered with Vitamin A at 6 months and with YF and MR vaccines at 9 months of age during EPI visits, without immune response impairment to any vaccine antigen or negative safety effect.

中文翻译：

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RTS，S / AS01疟疾疫苗与麻疹，风疹和黄热病疫苗一起在加纳儿童中的免疫原性和安全性：IIIb期，多中心，非劣效，随机，开放，对照试验

背景

为了优化针对年幼儿童的疫苗实施访问，在6个月大的扩展免疫计划（EPI）访问期间，连同维生素A补充剂和第三次RTS，在第一轮RTS，S / AS01疟疾疫苗的有效管理是有效的， S / AS01与9个月大的黄热病（YF），麻疹和风疹疫苗在同一天剂量。当与YF和联合麻疹风疹（MR）疫苗共同给药时，我们评估了RTS，S / AS01的安全性和免疫原性。

方法

在此3b期，开放标签，对照研究（NCT02699099）中，将709名加纳儿童随机（1：1：1）分别于6、7.5和9个月大时接受RTS，S / AS01，并于6、7.5和9个月接受YF和MR疫苗9个月或10.5个月大（分别为RTS，S coad和RTS，S组）。第三组在9个月大时接受YF和MR疫苗，并将在10.5、11.5和12.5个月大时接受RTS，S / AS01（对照组）。所有儿童均在6个月大时接受维生素A。的免疫应答的疫苗抗原非劣效性进行评价1个月以下共同施用与RTS，S / AS01或EPI疫苗（YF和MR疫苗）单独使用预先定义的非劣效性的标准。评估安全性，直到研究月4.5。

结果

与单独使用RTS，S / AS01相比，当将RTS，S / AS01与YF和MR疫苗共同给药时，证明了抗环子孢子和抗乙型肝炎病毒表面抗原的抗体反应非劣。当与YF和MR疫苗共同施用RTS，S / AS01与单独使用YF和MR疫苗时，证明了对麻疹，风疹和YF抗原的抗体反应非劣效性。所有组的所有疫苗的安全性在临床上都是可以接受的。

结论

RTS，S / AS01可以在EPI访问期间与6个月大的维生素A以及9个月大的YF和MR疫苗共同给药，而不会对任何疫苗抗原产生免疫应答损害或产生负面安全影响。