A third generation, purified fusion protein (PFP-3) vaccine was developed to prevent severe respiratory syncytial virus (RSV) disease in high-risk groups. A phase II, multi-center, adjuvant-controlled trial was performed in RSV seropositive children with cystic fibrosis (CF); 151 received the adjuvant-control and 143 received the vaccine. Details of the vaccine-induced immune response are presented. At enrollment, RSV-specific, serum antibodies were comparable between both groups. A highly sensitive and specific serum antibody vaccine profile was established for the PFP-3 vaccine. At post-vaccination and end-of-study, RSV-specific, neutralizing antibody (Nt Ab) and binding antibody (Bd Ab) to the fusion (F) protein were significantly higher in PFP-3 vaccinees. After 28 days post-vaccination, Nt Ab and Bd Ab to F protein titers declined slowly at rates of 0.23 and 0.37log2 per month, respectively. The PFP-3 vaccine-induced a robust immune response that lasted throughout the RSV season.
Bibliographical noteFunding Information:
Presented in part at Fourteenth Annual North American Cystic Fibrosis Conference, November 11, 2000, Baltimore, Maryland, Support: Collaborative Research Agreement between the Cystic Fibrosis Foundation and Wyeth-Lederle Vaccines; Cystic Fibrosis Foundation grant number: Piedra-99AO.
- Children with cystic fibrosis
- RSV vaccine
- Respiratory syncytial virus