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Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

Background. Herpes zoster (HZ) and postherpetic neuralgia (PHN) cause significant morbidity in older adults. The incidence and severity of HZ and PHN increase with age in association with an age-related decline in varicella-zoster virus (VZV)-specific cell-mediated immunity (VZV-CMI). VZV vaccines can boost VZV-CMI. Therefore, we tested the hypothesis that VZV vaccination would protect older adults against HZ and PHN. Methods. We enrolled 38,546 adults ⩾60 years of age in a randomized, double-blind, placebo-controlled trial of an investigational HZ vaccine and actively followed subjects for the development of HZ. The primary end point was the burden of illness due to HZ (HZ BOI), a composite measure of the incidence, severity, and duration of pain and discomfort caused by HZ. The secondary end point was the incidence of PHN. Results. Subject retention was >95%. HZ vaccine reduced the HZ BOI by 61.1% (95% confidence interval [CI], 51.1%–69.1%; P < .001) and reduced the incidence of PHN by 66.5% (95% CI, 47.5%–79.2%; P < .001). The incidence of HZ was also reduced by 51.3% (95% CI, 44.2%–57.6%; P < .001). HZ vaccine was well tolerated; injection site reactions were generally mild. HZ vaccine neither caused nor induced HZ. Conclusion. The Shingles Prevention Study demonstrated that HZ vaccine significantly reduced the morbidity due to HZ and PHN in older adults.

Herpes zoster and postherpetic neuralgia occur more often with increasing age. In this controlled trial among 38,546 adults 60 years of age or older, vaccination with a live attenuated varicella–zoster vaccine reduced the incidence of postherpetic neuralgia by 66.5 percent (as compared with placebo) and the incidence of herpes zoster by 51.3 percent. In adults 60 years of age or older, vaccination with a live attenuated varicella–zoster vaccine reduced the incidence of postherpetic neuralgia by 66.5 percent (as compared with placebo) and the incidence of herpes zoster by 51.3 percent. Herpes zoster, or shingles, is characterized by unilateral radicular pain and a vesicular rash that is generally limited to a single dermatome. 1 , 2 Herpes zoster results from reactivation of latent varicella–zoster virus (VZV) within the sensory ganglia. 3 , 4 The incidence and severity of herpes zoster increase with advancing age; more than half of all persons in whom herpes zoster develops are older than 60 years. Complications occur in almost 50 percent of older persons with herpes zoster. 3 – 5 The most frequent debilitating complication is postherpetic neuralgia, a neuropathic pain syndrome that persists or develops after the dermatomal rash has healed. . . .

BackgroundA double-blind, placebo-controlled trial that involved 38,546 subjects ⩾60 years old demonstrated efficacy of a high-potency live-attenuated Oka/Merck varicella-zoster virus (VZV) vaccine. The trial included an immunology substudy to determine the relationship of VZV-specific immune responses to vaccination and clinical outcome MethodsThe immunology substudy enrolled 1395 subjects at 2 sites where blood samples obtained prior to vaccination, at 6 weeks after vaccination, and at 1, 2, and 3 years thereafter were tested for VZV-specific cell-mediated immunity (VZV-CMI) by γ-interferon ELISPOT and responder cell frequency assays and for VZV antibody by glycoprotein ELISA ResultsVZV-CMI and VZV antibodies were significantly increased in vaccine recipients at 6 weeks after vaccination. The vaccine-induced increases in VZV-CMI persisted during the 3 years of follow-up, although their magnitude decreased over time. The magnitude of these VZV-specific immune responses was greater in subjects 60–69 years old than in subjects ⩾70 years old ConclusionsThe zoster vaccine induced a significant increase in VZV-CMI and VZV antibody. The magnitude and duration of the boost in VZV-CMI in vaccine recipients and the relationship of this boost to age paralleled the clinical effects of the vaccine observed during the efficacy trial. These findings support the hypothesis that boosting VZV-CMI protects older adults against herpes zoster and postherpetic neuralgia

As many as 9000 pregnancies annually may be complicated by varicella, which creates management problems for the woman and her fetus or newborn. Estimates on risk to the fetus and to neonates vary widely, making counseling difficult. Likewise, the efficacy of passive immunization of pregnant women or their exposed newborns is not precisely known. In addition to these problems in clinical management, questions remain about the developmental immunology of varicella-zoster virus infection. For example, why do infants exposed in utero to the virus get zoster at an early age and why does passive immunization of newborns appear to be less effective than immunization of older individuals?

CHICKENPOX (varicella) is a much less serious illness than poliomyelitis, diphtheria, or pertussis. Thus, one would not expect a chickenpox vaccine to reduce morbidity and mortality to the same extent as immunization against these other diseases. Uncomplicated chickenpox is far less debilitating than the usual case of measles. A sophisticated study design is therefore required to demonstrate that treatment affects the course of this self-limiting illness. Expectations of prevention or therapy must be clearly defined. Statistical differences between treatment and placebo groups will not necessarily imply results that are clinically important. Less than 5 percent of the economic burden of . . .

Although a number of studies have documented that casual household contact does not result in the transmission of HIV, isolated cases of person-to-person transmission have been reported. We report a study of household transmission in which the families were unaware the children were infected with HIV and thus took no precautions to prevent transmission. Twenty-two family members of nine transfusion-associated HIV-infected children were studied for transmission of HIV in households. There was a total of 174 person-year of household exposure; 76 of these exposure years were before the diagnosis of HIV infection in the index child. All family members tested negative for HIV by ELISA. Sharing household facilities, and interactions with the infected child including kissing, bathing, sleeping with, and helping to bathe, dress, and eat, did not result in transmission. Interactions that could theoretically result in person-to-person transmission occurred in these households such as caring for nose bleeds, biting, and home health care procedures. The findings of this and other studies support the participation of HIV-infected infants and children in out-of-home care programs. It remains prudent, however, to observe current recommendations for prevention of HIV-1 for all individuals regardless of whether HIV status is known.

Nonspecific reactions to the membrane antigen of varicella-zoster virus were found by fluorescent antibody assay in the sera of three children susceptible to the virus; one of these children subsequently developed varicella. None of the three sera, however, contained antibody to varicella-zoster virus that was detectable by enzyme-linked immunosorbent assay (ELISA). Moreover, the results of the ELISA clearly distinguished immune from susceptible individuals. The negative range was established with sera obtained from 15 individuals prior to the onset of varicella, and the positive range was established with sera obtained from 75 healthy donors with a history of varicella. The results of the ELISA correlated well with those of the fluorescent antibody assay (r = +0.84). Heterologous reactions to herpes simplex virus were found in one of seven sera tested, and such reactions to cytomegalovirus were found in two of five sera. Heterologous reactions to Epstein-Barr virus were found in none of eight sera tested. ELISA is easy, sensitive, and reproducible and can be used for routine screening for susceptibility to varicella.