Scientific Publications by FDA Staff

Vaccine 2007 Dec 21;26(1):59-66

Plaque reduction neutralization test for measles antibodies: Description of a standardised laboratory method for use in immunogenicity studies of aerosol vaccination.

Cohen BJ, Audet S, Andrews N, Beeler J, WHO working group on measles plaque reduction neutralization test

Cohen, BJ (reprint author), Hlth Protect Agcy, Ctr Infect, London NW9 5EQ, England Hlth Protect Agcy, Ctr Infect, London NW9 5EQ, England US FDA, Ctr Biol Evaluat & Res, Bethesda, MD 20892 USA

BACKGROUND: Clinical trials of measles vaccination administered as aerosol are planned with the aim of obtaining licensure. Measles antibody levels will be measured using the plaque reduction neutralization test (PRNT) to assess antibody responses as a surrogate marker of efficacy. METHODS: A working group examined laboratory protocols for measles PRNT in use at three reference centres and agreed to a standardised procedure, which was subsequently validated. RESULTS: Assay validation showed quantitative results varied approximately threefold both within and between assays. The lower limit of detection was approximately 20milliInternational Units/mL. CONCLUSIONS: A standardised laboratory protocol for measles PRNT was established and validated for use in clinical trials of aerosolized measles vaccines.