Three dose levels of a maternal respiratory syncytial virus vaccine candidate are well tolerated and immunogenic in a randomized trial in non-pregnant women.

Abstract

BACKGROUND\nRespiratory syncytial virus (RSV) causes respiratory tract infections, which may require hospitalization especially in early infancy. Transplacental transfer of RSV antibodies could confer protection to infants in their first months of life.\n\n\nMETHODS\nIn this first-in-human, placebo-controlled study, 502 healthy non-pregnant women were randomized 1:1:1:1 to receive a single dose of unadjuvanted vaccine containing 30/60/120 µg of RSV fusion (F) protein stabilized in the prefusion conformation (RSVPreF3), or placebo.\n\n\nRESULTS\nSolicited local adverse events (AEs) were more frequently reported in the RSVPreF3 groups (4-53.2%) vs placebo (0-15.9%); most were mild/moderate. Unsolicited AEs were comparably reported among groups. Three serious AEs were reported; none was vaccination-related. Compared with pre-vaccination values, anti-RSV A neutralizing antibody geometric mean titers and anti-RSVPreF3 immunoglobulin G geometric mean concentrations increased 8-14-fold and 12-21-fold at day (D)8 and persisted 5-6-fold and 6-8-fold higher until D91 in the RSVPreF3 groups vs 1-fold in placebo. Comparisons at D8 and D31 showed that the higher dose levels were significantly more immunogenic than the lowest one.\n\n\nCONCLUSIONS\nThe RSVPreF3 vaccine was well tolerated and immunogenic. The 60 and 120 µg dose levels were selected for further investigation in pregnant women.