Human-rhesus reassortant rotavirus vaccines: Safety and immunogenicity in adults, infants, and children

Neal A. Halsey, Edwin L. Anderson, Stephen D. Sears, Mark Steinhoff, Modena Wilson, Robert B. Belshe, Karen Midthun, Albert Z. Kapiklan, Robert M. Chanock, Roberta Samorodin, Barbara Burns, Mary Lou Clements

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Abstract

Human-rhesus reassortant rotavirus vaccines derived from rhesus rotavirus and human rotavirus serotypes 1, 2, or 4 were administered to adults, children, and infants after they had been given sodium bicarbonate buffer. Over 70% of infants and children developed antibody responses to or shed the candidate vaccine viruses. Individuals with prevaccination serum neutralization antibody titers ≤1:160 had significantly (P<.0001) higher response rates than did individuals with prevaccination titers ≥1:320. Similarly, shedding of vaccine viruses occurred significantly (P =.03) more often in children than adults and was inversely correlated with prevaccination antibody titers. No illnesses were observed in adults, and the vaccines were well tolerated in children. An increased rate of low-grade, transient fever (38.0-38.8 C) was noted only in children given serotype 2 vaccine, compared with controls (P =.006). No significant differences in the average number of unformed stools passed during the seven days after vaccination were noted in vaccinees versus controls. These vaccine strains are currently undergoing further evaluation in expanded clinical trials.

Original languageEnglish (US)
Pages (from-to)1261-1267
Number of pages7
JournalJournal of Infectious Diseases
Volume158
Issue number6
DOIs
StatePublished - Dec 1988

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ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Halsey, N. A., Anderson, E. L., Sears, S. D., Steinhoff, M., Wilson, M., Belshe, R. B., Midthun, K., Kapiklan, A. Z., Chanock, R. M., Samorodin, R., Burns, B., & Lou Clements, M. (1988). Human-rhesus reassortant rotavirus vaccines: Safety and immunogenicity in adults, infants, and children. Journal of Infectious Diseases, 158(6), 1261-1267. https://doi.org/10.1093/infdis/158.6.1261