Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States.

Background: The potential for vaccines to induce autoimmunity has been the subject of considerable investigation and autoimmune induction remains a common focus for vaccine safety research. This study assessed the risk of new onset autoimmune conditions among males receiving the 4-valent human papillomavirus (HPV) vaccine (4vHPV).

Methods: Within a US health insurance claims database, we formed a cohort of male 4vHPV vaccine recipients between 2009 and 2016, along with a propensity score matched cohort of males who did not receive the 4vHPV vaccine.

Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study.

The 4-valent human papillomavirus (HPV) vaccine (4vHPV vaccine), Gardasil®, is indicated for the prevention of several HPV-related diseases. The objective was to assess the safety of 4vHPV vaccine administered to males as part of routine care. The study used a US health insurance claims database, and included males, age 9 to 26 years, who initiated 4vHPV between October 2009 and December 2016.

Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention.

Background: Postherpetic neuralgia (PHN) occurs in 5-30% of individuals with herpes zoster (HZ) and is characterized by long-lasting pain. Zoster vaccine live (ZVL) is licensed for people 50 years and older to prevent HZ and PHN. This study evaluated vaccine effectiveness (VE) of ZVL against PHN.

Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study.

A live attenuated zoster vaccine was licensed in the United States in 2006 for prevention of shingles in persons aged 60 years or older; the indication was extended in 2011 to cover those aged 50-59 years. We assessed vaccine effectiveness (VE) against shingles for 8 years after immunization at Kaiser Permanente Northern California. VE was estimated by Cox regression with a calendar timeline that was stratified by birth year.

Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

Background: Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed.

Pneumococcal serotype distribution: A snapshot of recent data in pediatric and adult populations around the world.

S. pneumoniae infection remains a serious public health concern despite the availability of vaccines covering up to 23 of more than 94 known serotypes. The purpose of the present study was to monitor recent serotype distribution data.

Impact of vaccination on the epidemiology of varicella: 1995-2009.

Background: When varicella vaccine was licensed in the United States in 1995, there were concerns that childhood vaccination might increase the number of adolescents susceptible to varicella and shift disease toward older age groups where it can be more severe.

Methods: We conducted a series of 5 cross-sectional studies in 1994 to 1995 (prevaccine), 2000, 2003, 2006, and 2009 in Kaiser Permanente of Northern California to assess changes in varicella epidemiology in children and adolescents, as well as changes in varicella hospitalization in people of all ages. For each study, information on varicella history and varicella occurrence during the past year was obtained by telephone survey from a sample of ∼8000 members 5 to 19 years old; varicella hospitalization rates were calculated for the entire membership.

Complications of herpes zoster in cancer patients.

Cancer patients tend to have a higher incidence of herpes zoster (HZ), but little is known about their risk of HZ complications. We conducted a retrospective study of 424 newly diagnosed hematologic (HM, n = 140) and solid tumor malignancy (STM, n = 284) patients who developed HZ between January 2001 and December 2006 to measure the frequency and identify risk factors of HZ complications. Patients were adult members of Kaiser Permanente Northern California.

Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study.

Background: Varicella vaccine was licensed in the United States in 1995 for individuals ≥12 months of age. A second dose was recommended in the United States in June 2006. Varicella incidence and vaccine effectiveness were assessed in a 14-year prospective study conducted at Kaiser Permanente Northern California.

Safety of Zostavax™--a cohort study in a managed care organization.

Background: Zostavax™ is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure (Phase IV) study was conducted at Kaiser Permanente Northern California (KPNC), a US managed care organization, to assess the safety of zoster vaccine in people 60 years of age or older, vaccinated in routine medical care.

Methods: We performed a cohort study, comparing rates of clinical events resulting in hospitalizations or emergency department visits in a 42-day risk time period immediately following vaccination with rates in the same cohort in a subsequent comparison time period.

Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance.

The Adult/Adolescent Vaccination Report Card (VRC) was developed and validated by Merck in 1998 for use in vaccine clinical trials to collect information from trial subjects on complaints for both local and systemic events after vaccination. This short report describes the revision to the original validated VRC in order to align with the guidelines outlined in the 2007 FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Since the VRC elicits trial subjects' self-reports of any adverse experiences (AE) occurring post vaccination, it was important that subsequent modifications of the VRC retained the original user-friendly characteristics while gathering the appropriate information to align with the FDA Guidance.

Work and productivity loss related to herpes zoster.

Objective: To estimate absenteeism and presenteeism-related work loss due to herpes zoster (HZ) among working individuals of 50-64 years of age.

Methods: This telephone survey included individuals with ≥1 insurance claim for HZ in the past year in administrative claims data from five US commercial health plans. Demographic information, characteristics of the HZ episode; impact of HZ on activities of daily living (ADL), and work days loss and productivity were surveyed.

Herpes zoster recurrences more frequent than previously reported.

Objective: To present population-based estimates of herpes zoster (HZ) recurrence rates among adults.

Patients And Methods: To identify recurrent cases of HZ, we reviewed the medical records (through December 31, 2007) of all Olmsted County, Minnesota, residents aged 22 years or older who had an incident case of HZ between January 1, 1996, and December 31, 2001. Kaplan-Meier curves and Cox regression models were used to describe recurrences by age, immune status, and presence of prolonged pain at the time of the incident HZ episode.

Efficacy of caspofungin as salvage therapy for invasive aspergillosis compared to standard therapy in a historical cohort.

In a non-comparative study, caspofungin was effective salvage therapy for approximately half of the patients refractory to or intolerant of standard antifungal agents for invasive aspergillosis. To establish a frame of reference for these results, we compared the response to caspofungin with responses to other antifungal agents in a historical cohort of similar patients. The efficacy could be evaluated in 83 patients who received caspofungin 50 mg daily after a 70-mg loading dose.

Health care utilization and cost burden of herpes zoster in a community population.

Objective: To conduct a population-based study to assess health care utilization (HCU) and costs associated with herpes zoster (HZ) and its complications, including postherpetic neuralgia (PHN) and nonpain complications, in adults aged 22 years and older.

Patients And Methods: Medical record data on HCU were abstracted for all confirmed new cases of HZ from January 1, 1996, through December 31, 2001, among residents of Olmsted County, Minnesota. Herpes zoster-related costs were estimated by applying the Medicare Payment Fee Schedule to health care encounters and mean wholesale prices to medications.

Observational safety study of febrile convulsion following first dose MMRV vaccination in a managed care setting.

Background: A combined measles, mumps, rubella, varicella live vaccine (MMRV, Merck and Co., Inc., US) was recently licensed in the US.

Herpes zoster and postherpetic neuralgia: optimizing management in the elderly patient.

Herpes zoster (HZ) results from reactivation of varicella-zoster virus (VZV) that has been persistent and clinically dormant in spinal ganglia or cranial sensory nerves since primary infection with VZV. The most common reason for reactivation is a decline in zoster-specific cell mediated immunity as a result of aging (immunosenescence). More than two-thirds of HZ cases occur in people >or=60 years of age.

Lack of association between age at varicella vaccination and risk of breakthrough varicella, within the Northern California Kaiser Permanente Medical Care Program.

Background: Varicella vaccine currently is recommended for children between 12 and 18 months of age. However, rates of breakthrough varicella have been reported to be higher among children vaccinated before 14 or 15 months of age and to increase with time since vaccination.

Methods: An ongoing study at the Northern California Kaiser Permanente Medical Care Program is evaluating vaccine efficacy in 7585 children vaccinated with Varivax in 1995, when they were between 12 and 23 months of age.

Postherpetic neuralgia: epidemiology, pathophysiology and management.

Postherpetic neuralgia (PHN) is a neuropathic pain syndrome and is the most common complication of herpes zoster (HZ; shingles). PHN occurs mainly in HZ patients 60 years of age and older, in particular in those suffering from more severe acute pain and rash. Administration of antiviral drugs reduces the duration of pain associated with HZ.

A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction.

Objective: To establish accurate, up-to-date, baseline epidemiological data for herpes zoster (HZ) before the introduction of the recently licensed HZ vaccine.

Methods: Using data from January 1, 1996, to October 15, 2005, we conducted a population-based study of adult residents (Greater than or equal to 22 years) of Olmsted County, MN, to determine (by medical record review) the incidence of HZ and the rate of HZ-related complications. Incidence rates were determined by age and sex and adjusted to the US population.

The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults.

Objectives: To describe the interference of herpes zoster (HZ) pain and discomfort with activities of daily living (ADLs) and health-related quality of life (HRQL) during the acute rash phase, and to quantify the relationship between acute HZ pain and discomfort and impaired ADLs and HRQL in older persons.

Methods: Prospective, observational study of 160 HZ outpatients age > or =60 at 4 US study sites who completed the Zoster Brief Pain Inventory (ZBPI), Zoster Impact Questionnaire (ZIQ), McGill Pain Questionnaire, EuroQol, and SF-12 questionnaires on a predetermined schedule. Patients rated interference on a 0 to 10 scale for ADL items in the ZBPI and the ZIQ.