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

Robert B. Belshe, Frances K. Newman, Theodore F. Tsai, Ruth A. Karron, Keith Reisinger, Don Roberton, Helen Marshall, Richard Schwartz, James King, Frederick W. Henderson, William Rodriguez, Joseph M. Severs, Peter F. Wright, Harry Keyserling, Geoffrey A. Weinberg, Kenneth Bromberg, Richard Loh, Peter Sly, Peter McIntyre, John B. ZieglerJill Hackell, Anne Deatly, Alice Georgiu, Maribel Paschalis, Shin Lu Wu, Joanne M. Tatem, Brian Murphy, Edwin Anderson

Research output: Contribution to journalArticle

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 ≥38°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 ≥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.

Original languageEnglish (US)
Pages (from-to)462-470
Number of pages9
JournalJournal of Infectious Diseases
Volume189
Issue number3
DOIs
StatePublished - Feb 1 2004

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ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Belshe, R. B., Newman, F. K., Tsai, T. F., Karron, R. A., Reisinger, K., Roberton, D., Marshall, H., Schwartz, R., King, J., Henderson, F. W., Rodriguez, W., Severs, J. M., Wright, P. F., Keyserling, H., Weinberg, G. A., Bromberg, K., Loh, R., Sly, P., McIntyre, P., ... Anderson, E. (2004). Phase 2 Evaluation of Parainfluenza Type 3 Cold Passage Mutant 45 Live Attenuated Vaccine in Healthy Children 6-18 Months Old. Journal of Infectious Diseases, 189(3), 462-470. https://doi.org/10.1086/381184