Immunogenicity and Safety of Respiratory Syncytial Virus Subunit Vaccine in Seropositive Children 18-36 Months Old

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Abstract
Twenty-six children (aged 18–36 months) previously hospitalized for respiratory syncytial virus (RSV) infection were randomized to receive 50 αg of an RSV subunit vaccine composed primarily of F glycoprotein or saline placebo by intramuscular injection, Serum was obtained at entry and at 1 and 6 months after vaccination for detection of antibody to F glycoprotein and G glycoprotein of subtypes A (Ga) or B (Gb) and of neutralizing antibody (nAb). At 1 month, by comparing the baseline values, vaccinees had statistically significant increases in geometric mean antibody titer (GMT) of more than fourfold to F(P = .0001), Ga(P = .0001), Gb(P = .003), and nAb(P = .009). No differences in GMT were observed between F protein vaccine and placebo recipients at entry, nor between placebo recipients at entry and 1 month. RSV infections were identified in 7 placebo recipients (4 by both viral identification and seroconversion, 3 by seroconversion alone). No vaccine recipient had RSV infection documented in the 6 months after vaccination (P = .003). There were no significant vaccine-related side effects, and no evidence of enhanced respiratory illnesses was observed. The subunit F protein vaccine appears safe and immunogenic and may prevent infection in healthy children primed by prior RSV infection.

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