1. A Randomized, Blinded, Controlled, Dose-Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age.
- Author
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Glenn, Gregory M., Fries, Louis F., Thomas, D. Nigel, Smith, Gale, Kpamegan, Eloi, Hanxin Lu, Flyer, David, Jani, Dewal, Hickman, Somia P., Piedra, Pedro A., and Lu, Hanxin
- Subjects
RESPIRATORY syncytial virus ,RECOMBINANT fusion proteins ,NANOPARTICLES ,WOMEN'S health ,RANDOMIZED controlled trials ,BLIND experiment ,PALIVIZUMAB ,RESPIRATORY syncytial virus infections ,IMMUNOMODULATORS ,COMPARATIVE studies ,IMMUNITY ,IMMUNOGLOBULINS ,RESEARCH methodology ,MEDICAL cooperation ,RECOMBINANT proteins ,RESEARCH ,VIRAL antibodies ,EVALUATION research ,VIRAL vaccines ,STANDARDS ,PREVENTION - Abstract
Background: 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.Methods: 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.Results: 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).Conclusions: The vaccine appeared safe, immunogenic, and reduced RSV infections. Further development as a vaccine for use in maternal immunization is warranted.Clinical Trials Registration: NCT01704365. [ABSTRACT FROM AUTHOR]- Published
- 2016
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