Novavax, Inc, Gaithersburg, Maryland.
Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine, Houston, Texas.
J Infect Dis. 2016 Feb 1;213(3):411-22. doi: 10.1093/infdis/jiv406. Epub 2015 Aug 10.
Respiratory syncytial virus (RSV) is a leading cause of infant morbidity and mortality. A recombinant RSV fusion protein nanoparticle vaccine (RSV F vaccine) candidate for maternal immunization was tested for safety and immunogenicity in women of childbearing age.
Three hundred thirty women (18-35 years) were randomized to receive 1 or 2 doses of RSV F vaccine (60 or 90 µg) with or without aluminum phosphate adjuvant, or placebo at days 0 and 28. Safety was evaluated over 180 days; immunogenicity and RSV infection rates were evaluated over 112 days.
All vaccine formulations were well tolerated, without vaccine-related serious adverse events. Anti-F immunoglobulin G antibodies rose 6.5-15.6-fold, with significantly higher levels in 2-dose, adjuvanted regimens at day 56. Palivizumab-competitive antibody levels were undetectable at day 0 but increased up to 325 µg/mL at day 56. A 2.7- and 3.5-fold rise in RSV/A and RSV/B microneutralization antibodies were noted at day 56. Between days 56 and 112, 21% (12/56) of placebo recipients and 11% of vaccinees (26/244) showed evidence of a recent RSV infection (P = .04).
The vaccine appeared safe, immunogenic, and reduced RSV infections. Further development as a vaccine for use in maternal immunization is warranted.
NCT01704365.
呼吸道合胞病毒（RSV）是导致婴儿发病率和死亡率的主要原因。一种用于母体免疫的重组 RSV 融合蛋白纳米颗粒疫苗（RSV F 疫苗）候选药物已在育龄妇女中进行了安全性和免疫原性测试。
330 名女性（18-35 岁）随机分为 1 或 2 剂 RSV F 疫苗（60 或 90 µg）加或不加磷酸铝佐剂，或在 0 天和 28 天接受安慰剂。在 180 天内评估安全性；在 112 天内评估免疫原性和 RSV 感染率。
所有疫苗制剂均耐受良好，无疫苗相关严重不良事件。抗-F 免疫球蛋白 G 抗体升高 6.5-15.6 倍，在 2 剂、佐剂方案中于第 56 天的水平显著升高。帕利珠单抗竞争抗体水平在第 0 天无法检测到，但在第 56 天增加到 325 µg/mL。第 56 天 RSV/A 和 RSV/B 微量中和抗体升高 2.7-3.5 倍。在第 56 天至 112 天期间，21%（12/56）的安慰剂组和 11%的疫苗组（26/244）出现 RSV 近期感染证据（P=0.04）。
该疫苗表现出安全性、免疫原性和降低 RSV 感染的效果。进一步开发用于母体免疫的疫苗是合理的。
NCT01704365。
