CLINICAL TRIALS OF VARICELLA VACCINE IN HEALTHY ADOLESCENTS AND ADULTS

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MORBIDITY AND MORTALITY

Based on long-term experience by many clinicians as well as retrospective surveys of national health care statistics,8, 9 adults have a significantly higher per case morbidity with primary VZV infection than healthy children. The height and duration of the febrile period are greater and rash is frequently more severe, with a greater number of lesions, and requires more time for clearing. Constitutional symptoms including malaise, myalgias, anorexia, and dehydration are of a greater intensity.

SUSCEPTIBILITY IN ADOLESCENTS AND ADULTS

Although one report from Japan,15 using a neutralizing antibody assay, estimates that by age 9 virtually 98% of individuals are seropositive, experience in the United States differs. Published and unpublished serosurveys using the fluorescent antibody to membrane VZV antigen assay (FAMA) and ELISA indicate the seronegative rate in young adults to be between 7% and 11% (AM Arbeter and G Fleisher, unpublished results).2, 11, 20 Rates of seronegativity were higher in those raised in rural areas

IMMUNOGENICITY

Clinical trials with various strains and formulations of the live attenuated VZV vaccines in adolescents and adults have been conducted in Europe, Japan, and the United States. These clinical trials have varied in several parameters, including age definition, strain of virus, manufacturer of vaccine, plaque forming units (pfu) of virus per dose, viral antigen concentration, number and schedule of doses administered, and serologic assays used. The results have also varied. A brief overview of

CLINICAL REACTOGENICITY

In the Kuter trial12 98% and 94% of the vaccinees after the first and second dose, respectively, participated in follow-up. These large cohorts provided the authors with abundant information regarding the tolerability of the vaccine. There was no difference between the vaccine groups, based on the timing of the second injection, that affected clinical reactogenicity. The data are therefore combined for this discussion. There were no serious reactions after either injection of vaccine. The rates

PROTECTIVE EFFICACY AGAINST NATURAL INFECTION

In the trials reported by Gershon et al,4, 5, 8 where either Oka/RIT or Oka/Merck vaccine strains were used for adults, 37 vaccinees with household exposure to natural chickenpox were documented. Eleven of the vaccinees, all of whom had lost detectable antibody before exposure, developed MVLS. Most of these vaccinees had received only one dose of vaccine. This experience supports the notion that serologic testing has predictive value, at least against breakthroughs of full-blown clinical

VACCINE VIRUS REACTIVATION AS ZOSTER

Experience in healthy children and with children immunized with leukemia has revealed that zoster is at least no more likely after immunization with varicella vaccine than after natural infection. Experience for virus reactivation following adult vaccination has been limited by the size of the vaccinee pool. Hammerschlag et al7 reported a case of zoster in a vaccinee who had lost detectable antibodies, developed break-through natural varicella, and subsequently zoster with wild-type virus. This

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Address reprint requests to Allan M. Arbeter, MD, Department of Pediatric and Adolescent Medicine, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA 19141,

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From the Department of Pediatric and Adolescent Medicine, Albert Einstein Medical Center; and the Department of Pediatrics, Temple University School of Medicine, Philadelphia, Pennsylvania

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