A Randomized, Blinded, Controlled, Dose Ranging Study of a Respiratory Syncytial Virus Recombinant Fusion (F) Nanoparticle Vaccine in Healthy Women of Childbearing Age.
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 ug) 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 ug/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.
The Journal of infectious diseases