Phase 2 Evaluation of Parainfluenza Type 3 Cold Passage Mutant 45 Live Attenuated Vaccine in Healthy Children 6–18 Months Old

University of Adelaide, Tarndarnya, South Australia, Australia
The Journal of Infectious Diseases (Impact Factor: 5.78). 03/2004; 189(3):462-70. DOI: 10.1086/381184
Source: PubMed

ABSTRACT A phase 2 evaluation of live attenuated parainfluenza type 3 (PIV3)-cold passage mutant 45 (cp45) vaccine was conducted in 380 children 6-18 months old; 226 children (59%) were seronegative for PIV3. Of the 226 seronegative children, 114 received PIV3-cp45 vaccine, and 112 received placebo. No significant difference in the occurrence of adverse events (i.e., runny nose, cough, or temperature > or =38 degrees C) was noted during the 14 days after vaccination. There was no difference between groups in the occurrence of acute otitis media or serous otitis media. Paired serum samples were available for 109 of the seronegative vaccine recipients and for 110 of the seronegative placebo recipients; 84% of seronegative vaccine recipients developed a > or =4-fold increase in antibody titers. The geometric mean antibody titer after vaccination was 1 : 25 in the vaccine group and <1 : 4 in the placebo group. PIV3-cp45 vaccine was safe and immunogenic in seronegative children and should be evaluated for efficacy in a phase 3 field trial.

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    • "Currently, there are no vaccines or antivirals approved for the prevention and treatment of HPIV3 infection. Although the HPIV3 candidate vaccine cp45 (Belshe et al., 2004) was shown to be safe and immunogenic in young children in phase I and II trials, it still needs to be evaluated in phase III efficacy studies. Clinical evaluation of bovine/human PIV3 chimeras, another attractive HPIV3 candidate vaccine, is at the early stage of development (Durbin et al., 2003). "
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