Evaluation of a live, cold-passaged, temperature-sensitive, respiratory syncytial virus vaccine candidate in infancy.

Division of Infectious Disease, Dept. of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN 37232, USA. peter.wright@mcmail.vanderbilt.edu

The Journal of infectious diseases 2000 Nov

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A live-attenuated, intranasal respiratory syncytial virus (RSV) candidate vaccine, cpts-248/404, was tested in phase 1 trials in 114 children, including 37 1-2-month-old infants-a target age for RSV vaccines. The cpts-248/404 vaccine was infectious at 104 and 105 plaque-forming units in RSV-naive children and was broadly immunogenic in children >6 months old. Serum and nasal antibody responses in 1-2 month olds were restricted to IgA, had a dominant response to RSV G protein, and had no increase in neutralizing activity. Nevertheless, there was restricted virus shedding on challenge with a second vaccine dose and preliminary evidence for protection from symptomatic disease on natural reexposure. The cpts-248/404 vaccine candidate did not cause fever or lower respiratory tract illness. In the youngest infants, however, cpts-248/404 was unacceptable because of upper respiratory tract congestion associated with peak virus recovery. A live attenuated RSV vaccine for the youngest infant will use cpts-248/404 modified by additional attenuating mutations.

Citation

P F Wright, R A Karron, R B Belshe, J Thompson, J E Crowe, T G Boyce, L L Halburnt, G W Reed, S S Whitehead, E L Anderson, A E Wittek, R Casey, M Eichelberger, B Thumar, V B Randolph, S A Udem, R M Chanock, B R Murphy. Evaluation of a live, cold-passaged, temperature-sensitive, respiratory syncytial virus vaccine candidate in infancy. The Journal of infectious diseases. 2000 Nov;182(5):1331-42