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PubMed1993

Clinical survey of natural varicella compared with breakthrough varicella after immunization with live attenuated Oka/Merck varicella vaccine.

OBJECTIVE: To prospectively characterize varicella occurring in children previously immunized with a live attenuated varicella vaccine (breakthrough varicella) through daily observation by medical personnel and to compare it with natural varicella followed in the same manner. DESIGN: A blinded clinical survey. SETTING: Four pediatric practices (two private; two hospital-based). PARTICIPANTS: Healthy 12-month-old through 17-year-old children with chickenpox were studied; 92 had natural varicella and 58 had breakthrough varicella. SELECTION PROCEDURES AND INTERVENTIONS: Study personnel, unaware of vaccination status, documented the clinical characteristics of each patient in the office or at the patient's home each day from enrollment until the day after the total number of lesions increased less than 10%. A standard form documenting number and description of lesions, temperature, duration of illness, and associated clinical complaints was completed each day by the same study personnel. Acute and convalescent sera were obtained on breakthrough cases. MEASUREMENTS AND RESULTS: Antibody to varicella-zoster virus was measured by the glycoprotein-based enzyme-linked immunosorbent assay. Of those with sera available, 85% were serologically confirmed. Eighty-seven percent of enrollees had a known exposure to chickenpox, with at least two thirds of each group having a greater than 4-hour or a household exposure. The numbers of total and vesicular lesions were significantly higher in the natural varicella group, regardless of exposure status (P = .021 to < .001). The group with breakthrough varicella had a significantly lower incidence of fever (P < .001) and a significantly shorter duration of illness (P < .001). Other associated constitutional complaints and complications were not significantly different between groups. CONCLUSION: Varicella in vaccine recipients is clinically modified and significantly less severe than natural disease.

Adolescent↗
PubMed1999

Postmarketing evaluation of the safety and effectiveness of varicella vaccine.

BACKGROUND: The Oka strain of live attenuated varicella virus was licensed for use in healthy children in the United States in March, 1995. We report a postmarketing evaluation of the short term safety of this vaccine within Kaiser Permanente. METHODS: After licensure varicella vaccination was introduced into the preventive care program of the Northern California Kaiser Permanente Medical Care Program. Potential adverse events after vaccination with varicella vaccine were identified from automated clinical databases of hospitalizations, emergency room visits and clinic visits. Deaths were identified from automated clinical databases at Kaiser as well as from the State death records for California. To evaluate safety, rates of diagnosis-specific events in the risk periods were compared with the rates of such diagnosis-specific events in two self control and one historical control period. RESULTS: During the study period of April 1, 1995, to December 31, 1996, a total of 89753 adults and children received varicella vaccine. A total of 3200 relative risks were calculated, and of these 5 hospital diagnostic categories, 9 emergency visit diagnostic categories and 30 outpatient diagnostic categories demonstrated at least 1 relative risk with a P value of <0.05 in 1 or more age groups and in comparisons with 1 control period or more. The p value for these tests was not adjusted for multiple comparisons. Of these categories 14 demonstrated an increased risk either in more than 1 age group or against more than 1 comparison group. These categories included elective procedures, febrile seizure, febrile illness, well child, acute gastroenteritis, varicella, congenital anomaly, "rule out sepsis," trauma, viral syndrome, apnea, back pain, congenital valvular heart disease and vision evaluation for glasses. Of these the outcomes of elective procedure, congenital anomaly, congenital valvular heart disease, well child and vision evaluation for glasses were judged not to have a biologically plausible association with vaccination. A second diagnostic grouping included febrile illness, viral illness, febrile seizure and "rule out sepsis." In an analysis of these events which adjusted for the concomitant administration of M-M-R(II) vaccine, none of the associations was statistically associated with receipt of varicella vaccine. The diagnostic category of "rule out sepsis" still had a relative risk of 1.95 with P = 0.02. None of the children in the "rule out sepsis" category had positive bacteriologic cultures from any other normally sterile site. Because of the large number of gastroenteritis cases, we reviewed a random sample of 100 exposed and 100 unexposed cases. From this review no consistent time association or clustering of any of these events was seen in the exposed follow-up time interval. Only gastroenteritis and negative evaluations for sepsis were thought to be possibly associated with receipt of varicella vaccine. Although there was a statistically significant increased risk over the entire 30 day-period, there was no clustering of these events within the 30-day window. CONCLUSION: In this study population of 89753 children and adults, the varicella vaccine (Oka strain, Merck) appeared to have a favorable safety profile. In addition rates of varicella-like rash and of breakthrough cases were both low and consistent with the rates observed in prelicensure studies.

Adult↗
PubMed1996

Epidemiologic effects of varicella vaccination.

For a plausible range of values for the different efficacy characteristics of the live varicella (Oka) vaccine at different levels of coverage, modeling results suggest that routine immunization of preschool children would greatly reduce the number of primary varicella cases, whereas the shift in age distribution of cases would not result in increased overall morbidity as measured by number of hospitalizations. Although information about some of the vaccine assumptions is scanty, the combinations of assumptions leading to an increase in morbidity seem unlikely. A catch-up program in older children who have not yet had chickenpox will be important. The number and age distribution of the cases in vaccinees are sensitive to assumptions about the vaccine, especially the degree and distribution of partial protection against infection, relative residual infectiousness, and waning of immunity. Responsiveness to boosting by wild-type VZV infection was especially important in reducing the number of older cases. The advantage conferred by responsiveness to boosting depends on the level of transmission. The direct and indirect effects of vaccines and vaccination programs interact. Understanding how a vaccine works at the individual level is important for the vaccinated individual, but it also influences the overall public health benefits of an immunization programs. Lieu et al based a cost-effectiveness analysis of varicella vaccines on this model of varicella dynamics and assumptions about how the vaccines work. Models cannot replace biologic understanding. The purpose of such models is not to predict the number of cases of varicella, but to examine some possible consequences of introducing a vaccine into the routine immunization schedule of preschool children in the United States, effects of different vaccination strategies, and the benefits of a temporary catch-up program for older children. Modeling exercises of this sort force us to formalize our thinking, for instance about the vaccine mechanisms, and to admit our uncertainties, such as about the vaccine efficacy assumptions. Such models also show where more data need to be collected, for example, on boosting and waning of immunity and relative residual infectiousness. Improvements in the design of vaccine efficacy studies are necessary to provide the input to these models for looking at the long-term effects of vaccination programs. Frailty models can be used to analyze the data in the presence of heterogeneities in susceptibility. Waning can also be estimated using appropriate methods. Relative infectiousness of vaccinees with breakthrough cases can be measured by comparing the relative secondary attack rates when the index infected person is vaccinated and when the index infected person is unvaccinated. More studies are needed to understand how to evaluate responsiveness to boosting. Vaccine efficacy studies in the field should be designed to obtain better estimates of residual susceptibility, residual infectiousness, duration of protection, and the effects of boosting by reinfection with wild-type VZV.

Adolescent↗
PubMed2002

Aetiology, antifungal susceptibility, risk factors and outcome in 201 fungaemic children: data from a 12-year prospective national study from Slovakia.

A total of 201 cases of fungaemia in children in a 12-year national survey from seven University Paediatric Clinics in Slovakia in 1990-2001 was assessed to determine risk factors, therapy and outcome, and to compare those cases with fungaemia in 130 adult cancer patients studied in a similar survey. Four univariate analyses were performed to assess differences in aetiology, antifungal susceptibility and outcome between fungaemia in neonates and paediatric intensive care unit (ICU) patients as well as between paediatric and adult cancer patients with fungaemia. There was a significant difference in aetiology and antifungal susceptibility between the subgroups of children with fungaemia: 83.3% of neonates versus 40.2% in children with cancer were due to Candida albicans. None of the non-albicans Candida spp. (NAC) in neonates but 23.5% of NAC isolates from children with cancer were resistant to fluconazole. C. albicans caused 144 (71.1%) episodes and NAC 48 (23.7%) episodes. Trichosporon beigelii, Blastoschizomyces (Trichosporon) capitatus, Rhodotorula rubra and Cryptococcus laurentii were found less frequently in neonates than in children with cancer (18.8%). There were not many differences in risk factors between paediatric fungaemia and adult cancer fungaemia except C. albicans aetiology, corticosteroid use in therapy, breakthrough fungaemia after ketoconazole prophylaxis and meningitis as a complication, which were observed significantly more frequently among children than in adults, both with cancer and fungaemia. Thirty-three of the paediatric fungaemias were breakthrough cases and appeared frequently in children with cancer. Fifty-one (25.1%) children died with fungaemia (attributable mortality) and 25 (12.7%) due to underlying disease with fungaemia; overall mortality was 37.8% and there was no significant difference in death rates between the subgroups of paediatric patients (neonates, children in ICUs and children with cancer).

Adult↗
PubMed1984

Symposium on infectious complications of neoplastic disease (Part II). Immunoprophylaxis of varicella-zoster infections.

Because it is possible to identify groups of persons with a high risk of varicella development and also because it is possible to anticipate when an attack may occur, immunoprophylaxis for varicella has met with great success. In contrast, the nature of zoster--its unpredictability and low attack rate--makes immunoprophylaxis much more difficult to implement. Varicella may be modified by administration of varicella-zoster immune globulin within three days of a known exposure to the virus. Although interferon has not yet been used in an attempt to prevent or modify varicella in humans, it has been used successfully to abort an outbreak of simian varicella in a monkey colony. Thus it might be clinically useful, particularly for those who cannot be given varicella-zoster immune globulin within three days of exposure. Transfer factor has also been shown to induce at least partial immunity to varicella in children with leukemia. The duration of this protection is unknown, and further study of the efficacy of transfer factor against both varicella and possibly even against zoster seems warranted. Live attenuated varicella vaccine, although still experimental, seems now to be the most practical way to prevent severe varicella in high-risk persons. The vaccine is safe and immunogenic, even in children with underlying leukemia who are still receiving chemotherapy. Studies in Japan, Europe, and the United States have shown that most vaccinated leukemic children who are exposed are protected against severe disease, although mild breakthrough cases have been reported. Varicella vaccine's potential to cause zoster remains under study.

Animals↗
PubMed2006

The role of photochemical treatment with amotosalen and UV-A light in the prevention of transfusion-transmitted cytomegalovirus infections.

Primary cytomegalovirus (CMV) infection is usually asymptomatic in immunocompetent patients but can cause serious life-threatening complications in immunocompromised CMV-seronegative patients, including patients receiving a bone marrow or peripheral blood stem cell transplant, recipients of some solid-organ transplants, and low-birth-weight neonates. Current recommendations for preventing transfusion-transmitted CMV (TT-CMV) infection in these patients include exclusive use of CMV-seronegative and/or leukoreduced cellular blood components (red blood cells and platelets) for transfusion. However, breakthrough cases of TT-CMV still occur. Despite improving the safety of blood components, testing remains a reactive approach to blood safety. In contrast, pathogen inactivation technologies offer a proactive approach with the potential to further improve blood safety. To reduce the risks associated with platelet transfusions, a photochemical treatment (PCT) process using a combination of the psoralen amotosalen HCl and long-wavelength UV light has been developed and introduced into clinical practice in Europe. PCT has been shown to result in greater than 5.9-log reductions in infectivity of human CMV in platelet concentrates and to prevent the transfusion transmission of murine CMV in a mouse transfusion model. Thus, PCT pathogen inactivation may play a role in further reducing the incidence of TT-CMV infection in patients who are at risk for serious CMV disease. Because PCT is a technology that targets nucleic acids, it also offers a proactive process for the inactivation of a broad range of viral, bacterial, and protozoan pathogens in addition to CMV.

Animals↗
PubMed2000

Varicella vaccine.

Varicella vaccine is safe, effective, and cost-effective in healthy children, adolescents, and adults. Breakthrough cases of MVLS are significantly milder than wild-type varicella infection. No severe adverse events have been reported following vaccination, and the incidence of herpes zoster is less in vaccinees than in individuals who have had natural varicella infections. To date, there is no evidence waning immunity following vaccination. "New and improved" varicella vaccines that may be more effective than the current vaccine and can be stored at refrigerator temperatures may soon become available in the United States.

Adolescent↗
PubMed1984

Nursery-associated hepatitis A traced to a male nurse.

A small epidemic of nursery-associated hepatitis A (HA), in which silently infected children played a cryptic role in transmitting the illness to adult contacts, was investigated. It was found that a male nurse had transmitted HA to four children before he fell ill. He was not heard from for about two months as he was a part-time worker and was admitted to a local hospital in another prefecture. Two of the four silently infected children transmitted HA to their parents who then revealed the presence of nursery-associated HA. The epidemic was terminated by injection of human gamma globulin to nursery children and to antibody-negative parents, nursery staff and other contacts except for two breakthrough cases.

Adolescent↗
PubMed2003

CMV DNA is rarely detected in healthy blood donors using validated PCR assays.

BACKGROUND: Although serologic screening or WBC reduction of blood components can reduce the incidence of transfusion-transmitted CMV (TT-CMV) infection, 'breakthrough' cases of TT-CMV still occur and may produce serious sequelae. NAT of blood components for CMV DNA has been proposed to further reduce the risks of TT-CMV. However, large-scale studies to determine the utility of validated CMV NAT assays for donor screening have not been reported. STUDY DESIGN AND METHODS: Coded whole-blood samples (n=1000) were tested for the presence of CMV DNA using two CMV PCR assays previously validated in a multicenter trial (a nested PCR assay directed at the CMV UL93 open-reading frame and the Roche Monitor assay). Corresponding plasma samples were tested in parallel for the presence of anti-CMV using other assays (Abbott CMV EIA and Fujirebio/Olympus CMV particle agglutination assays). RESULTS: In total 416 and 514 of the samples tested as CMV-seropositive and -seronegative, respectively, by both antibody assays. The remaining 70 samples had discrepant serology results. Only 2 of the 1000 samples (both seropositive) had reproducibly detectable CMV DNA (positive in at least three of four replicates). CMV DNA was not reproducibly detected in seronegative samples or in samples with discrepant serology results. CONCLUSIONS: Although previous investigations showed frequent detection of CMV DNA in healthy CMV-seropositive (and some seronegative) blood donors, these studies were relatively small and the performance characteristics of their assays were difficult to evaluate. In contrast, the present large cross-sectional study of US donors utilized two previously validated PCR assays and demonstrated that CMV DNA is only rarely detectable in seropositive donors. Thus, the use of CMV PCR assays with optimal performance characteristics did not increase the detection of potentially infectious blood components beyond that provided by current serologic screening assays.

Antibodies, Viral↗
PubMedDate not supplied

Human immune responses to live attenuated varicella vaccine.

Experiences with the use of the live attenuated varicella vaccine for the immunization of varicella-susceptible adults and healthy and leukemic children are described. Healthy children, for whom a greater than 90% rate of seroconversion and protective efficacy was noted, showed the best response. Leukemic children experienced a 40%-50% rate of vaccine-associated rash; protective efficacy approached 90%. For adults, a 10% rate of vaccine-associated rash and a protective efficacy of 70% were noted. Breakthrough cases of vaccine were mild, indicating modification of the course of the illness by the vaccine.

Adult↗
PubMed1991

Lack of transmission of the live attenuated varicella vaccine virus to immunocompromised children after immunization of their siblings.

The safety of administering the live attenuated Oka/Merck varicella vaccine to the well siblings of children with malignancy was evaluated as a strategy for reducing the risk of household exposure to varicella among immunocompromised children. Susceptible well children were eligible for vaccination if the child with malignancy had leukemia, lymphoma, or solid tumor in remission for 3 months or longer. No evidence of vaccine virus transmission was found among 30 children with malignancy whose 37 healthy susceptible siblings were immunized with varicella vaccine. Varicella-zoster virus was not isolated from the oropharyngeal secretions taken from 17 vaccinees or their 14 immunocompromised siblings. None of the 30 immunocompromised children had vaccine-related rashes or showed immunologic evidence of subclinical varicella-zoster virus infection based on testing for varicella-zoster virus IgG antibodies and T-lymphocyte proliferation to varicella-zoster virus. Four healthy vaccinees eventually had mild breakthrough cases of varicella, with transmission to the high-risk sibling in 3 cases. However, even in these families, the immunocompromised children had been protected from household exposure varicella for at least 20 months early in the course of their immunosuppressive treatment.

Adolescent↗
PubMed1985

A multicentre trial of live attenuated varicella vaccine in children with leukaemia in remission.

Two hundred forty children with acute leukaemia in remission for at least 1 year were immunized with live attenuated varicella vaccine. All were susceptible to varicella before immunization. There was a seroconversion to varicella-zoster virus in approximately 85% after 1 dose, and in 97% after 2 doses. The major side effect was mild to moderate rash, seen mainly in children with maintenance chemotherapy suspended for 1 week before and 1 week after vaccination. Vaccinees with rash were at some risk (10%) to transmit vaccine virus to varicella susceptibles with whom they had close contact. Twenty-nine vaccinees were subsequently exposed to varicella in their households. The attack rate of clinical varicella in these vaccinees was 21%, which is significantly lower than the 80%-90% attack rate occurring in varicella susceptibles after household exposure. All these breakthrough cases of varicella were mild, even in leukaemics receiving chemotherapy. Varicella vaccine was approximately 80% effective in preventing clinical varicella in children with leukaemia and completely effective in preventing severe varicella in this high-risk group.

Acute Disease↗
PubMed2002

[Clinical outcome in cases of viral breakthrough during lamivudine therapy in chronic hepatitis B patients].

BACKGROUND/AIMS: Long-term lamivudine therapy can induce the emergence of lamivudine resistant hepatitis B virus (HBV) mutants. Clinically emergence of the mutant is expressed by the reappearance of disappeared HBV DNA in serum. Continued lamivudine treatment has been usually recommended in cases of viral breakthrough. However, the clinical outcome in patients with viral breakthrough is not clear. The aim of this study was to investigate the clinical course of chronic hepatitis B patients after viral breakthrough during lamivudine therapy. METHODS: A total of 74 patients with chronic hepatitis B who showed viral breakthrough after at least 6 months of lamivudine treatment were included in this study. They had positive HBeAg and HBV DNA before treatment. The median follow-up duration after breakthrough was 13 months. RESULTS: After viral breakthrough, only 8 patients (11%) maintained normal ALT levels and 66 patients (89%) showed elevation of ALT. 30 patients (41%) showed acute exacerbation of hepatitis (ALT increase over five-times upper normal limit). These acute exacerbations occurred within three months after breakthrough in 19 patients (63%). In the cases of acute exacerbation, 6 patients showed decompensated progression such as elevation of serum total bilirubin. One of them died of hepatic failure. A predictive factor for acute exacerbation was not found. HBeAg seroconversion occurred in 8 patients after viral breakthrough but their clinical course was highly variable. CONCLUSIONS: Chronic hepatitis B patients who had viral breakthrough during lamivudine therapy should be followed carefully and regularly in mind of potential clinical deterioration. New strategies are needed to manage the cases of acute exacerbation after viral breakthrough.

Adult↗
PubMed1987

Unilateral normal perfusion pressure breakthrough after carotid endarterectomy: case report.

The authors report a case of unilateral malignant cerebral edema that occurred after the removal of a high grade atheromatous lesion of the ipsilateral internal carotid artery. A form of unilateral normal perfusion pressure breakthrough caused by postischemic impairment of cerebrovascular autoregulation and exacerbated by systemic hypertension is thought to have contributed to this complication. Control of the hypertension and treatment of the cerebral edema with mannitol and dexamethasone led to a complete neurological recovery.

Aged↗
PubMed2004

An elementary school outbreak of varicella attributed to vaccine failure: policy implications.

BACKGROUND: Since licensure in the United States, studies have shown that varicella vaccine's overall effectiveness ranges from 44% to 100%, with substantial protection against moderate and severe varicella; however, breakthrough illness has been documented in up to 56% of vaccinated individuals. METHODS: A varicella outbreak occurred in a Minnesota school with 319 students. Phone surveys were conducted with students' parents. Information was collected on students who had recent varicella infections, including onset date, rash characteristics, duration, and underlying medical conditions. RESULTS: Fifty-four cases occurred after a primary breakthrough case. Twenty-nine (53%) students had been vaccinated. Unvaccinated students had an increased risk of moderate varicella, compared with vaccinated students (relative risk [RR], 4.4 [95% confidence interval [CI], 2.2-9.1]; P<.001). The vaccine was 56% effective at preventing any varicella and 90% effective against moderate illness. Students vaccinated >or=5 years before the outbreak had a greater risk of breakthrough varicella than did those vaccinated within <or=4 years (RR, 2.6 [95% CI, 1.3-5.4]; P<.01). CONCLUSIONS: Vaccinated students presented with milder varicella symptoms than did unvaccinated students. Individuals with breakthrough illness can be highly infectious. Time since varicella vaccination was associated with illness. Despite 29 breakthrough cases, the varicella vaccine conferred a high degree of protection against moderate illness.

Chickenpox↗