CLINICAL TRIALS OF VARICELLA VACCINE IN HEALTHY ADOLESCENTS AND ADULTS
Section snippets
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 Published and unpublished serosurveys using the fluorescent antibody to membrane VZV antigen assay (FAMA) and ELISA indicate the seronegative rate in young adults to be between 7% and 11% (AM Arbeter and G Fleisher, unpublished results).2, 11, 20 Rates of seronegativity were higher in those raised in rural areas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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Cited by (33)
Canadian Association of Gastroenterology Clinical Practice Guideline for Immunizations in Patients With Inflammatory Bowel Disease (IBD)—Part 1: Live Vaccines
2021, GastroenterologyCitation Excerpt :Key evidence: In temperate countries, there is near-universal varicella zoster virus (VZV) seroconversion by late childhood.41,42 Primary VZV infection is often more severe in adults than in children.43 In contrast to primary VZV infection, reactivation of the VZV (HZ or shingles) tends to occur more frequently in older adults (ie, older than 50 years) and in those who are immunosuppressed (see recommendations 10A and 10B in part 2).11,44–49
A systematic review and meta-analysis of seroprevalence of varicella zoster virus: A nationwide population-based study
2017, Journal of Clinical VirologyCitation Excerpt :There are some potential consequences of VZV infection; serious complications such as skin lesions, pneumonia, encephalitis, and hepatitis that threaten adolescents [8]. This may lead to mortality in some cases [7]. Moreover, pregnant women are another group infected by varicella with high risk of transmission to fetus and newborns [40].
Vaccines against varicella-zoster virus (VZV)
2015, Enfermedades Infecciosas y Microbiologia ClinicaSafety and immunogenicity of the live attenuated varicella vaccine following T replete or T cell-depleted related and unrelated allogeneic hematopoietic cell transplantation (alloHCT)
2011, Biology of Blood and Marrow TransplantationCitation Excerpt :Although varicella in childhood is generally a mild disease, immunocompetent individuals who develop chickenpox later in life develop a more serious infection, associated with an increased risk of visceral disease and need for hospitalization [1,2].
Vaccines against varicella-zoster virus
2008, Enfermedades Infecciosas y Microbiologia Clinica
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