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primary studies published RCT

Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: a multi-center trial in children with cystic fibrosis.

  • Year: 2003
  • Date: 2003
  • Author: Piedra PA
Source

Vaccine. 2003 Jun 2;21(19-20):2448-60.

Study design (if review, criteria of inclusion for studies)

phase II, multi-center, adjuvant-controlled trial

Participants

respiratory syncytial virus (RSV) seropositive children with cystic fibrosis (CF)

Interventions

vaccine or adjuvant-control

Outcome measures

RSV-specific, serum antibodies

Main results

At enrollment, RSV-specific, serum antibodies were comparable between both groups. 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 0.37 log2 per month, respectively

Authors' conclusions

The PFP-3 vaccine-induced a robust immune response that lasted throughout the RSV season.

Keywords: Child; fusion; Immunization; Infant; Infection; pharmacological_intervention; Proteins; Recombinant Proteins; Respiratory Syncytial Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Virus; Bronchiolitis;