Efficacy results of a trial of a herpes simplex vaccine.

BACKGROUND: Two previous studies of a herpes simplex virus type 2 (HSV-2) subunit vaccine containing glycoprotein D in HSV-discordant couples revealed 73% and 74% efficacy against genital disease in women who were negative for both HSV type 1 (HSV-1) and HSV-2 antibodies. Efficacy was not observed in men or HSV-1 seropositive women. METHODS: We conducted a randomized, double-blind efficacy field trial involving 8323 women 18 to 30 years of age who were negative for antibodies to HSV-1 and HSV-2. At months 0, 1, and 6, some subjects received the investigational vaccine, consisting of 20 µg of glycoprotein D from HSV-2 with alum and 3-O-deacylated monophosphoryl lipid A as an adjuvant; control subjects received the hepatitis A vaccine, at a dose of 720 enzyme-linked immunosorbent assay (ELISA) units. The primary end point was occurrence of genital herpes disease due to either HSV-1 or HSV-2 from month 2 (1 month after dose 2) through month 20. RESULTS: The HSV vaccine was associated with an increased risk of local reactions as compared with the control vaccine, and it elicited ELISA and neutralizing antibodies to HSV-2. Overall, the vaccine was not efficacious; vaccine efficacy was 20% (95% confidence interval [CI], -29 to 50) against genital herpes disease. However, efficacy against HSV-1 genital disease was 58% (95% CI, 12 to 80). Vaccine efficacy against HSV-1 infection (with or without disease) was 35% (95% CI, 13 to 52), but efficacy against HSV-2 infection was not observed (-8%; 95% CI, -59 to 26). CONCLUSIONS: In a study population that was representative of the general population of HSV-1- and HSV-2-seronegative women, the investigational vaccine was effective in preventing HSV-1 genital disease and infection but not in preventing HSV-2 disease or infection. (Funded by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline; ClinicalTrials.gov number, NCT00057330.).

HSV-1 and HSV-2 seroprevalence in the united states among asymptomatic women unaware of any herpes simplex virus infection (Herpevac Trial for Women).

OBJECTIVES: Recent evidence suggests that the epidemiology of herpes simplex viruses (HSVs) is changing because fewer HSV-1 infections are acquired in childhood and increased sexual transmission of HSV-1 is reported. The objective of the study was to assess the seroprevalence of type-specific antibodies to HSV-1 and HSV-2 in the United States. METHODS: We used the Western blot antibody screening data from a large phase III vaccine efficacy trial (Herpevac Trial for Women) to assess the seroprevalence of type-specific antibodies to HSV-1 and HSV-2 in the United States. RESULTS: The antibody status of 29,022 women (>31,000 women interviewed and then had their blood drawn for the HSV testing [29,022 women]) between the ages of 18 and 30 years in the United States revealed that increasing age was associated with increasing seroprevalence to HSV. Overall, in asymptomatic women unaware of any HSV infection, HSV-1/-2 status was positive/negative in 45%, negative/positive in 5%, positive/positive in 7%, negative/negative in 38%, and indeterminate in 5%. HSV-1 infections were more common in Hispanic and non-Hispanic black women and in the US northeast and in individuals living in urban areas. HSV-2 was more common in non-Hispanic black women, the US south, and in urban areas. CONCLUSIONS: Seronegative status for both HSV-1 and HSV-2 was the second most common finding after positive antibody to HSV-1 but negative antibody to HSV-2. Despite recent changes in genital herpes epidemiology, most women acquired HSV-1 but not HSV-2 infections before 18 years of age. Among participants screened for study participation and who were unaware of any HSV infection, progressively higher prevalence of the HSV-1 or HSV-2 antibody was observed in older subjects. Many women who test positive for HSV-1 and/or HSV-2 are unaware of their status.

How we didn't clean up until we washed our hands: shigellosis in an elementary and middle school in North Texas.

BACKGROUND: Shigella outbreaks often continue for months and are linked frequently to poor hygiene and hand washing. Such outbreaks are found often in day care facilities, but rarely are reported in schools. We present the investigation of an outbreak in autumn 2007 at a building that housed an elementary school and a middle school in separate wings in a small Texas city north of Dallas-Fort Worth. METHODS: We canvassed local hospitals, school attendance records, and physician offices for cases. Ill individuals were interviewed using a standard questionnaire for symptoms, disease onset, and the presence of the illness in an ill person's household. RESULTS: A music teacher was the index case for this outbreak of gastrointestinal illness caused by S. sonnei. Ten percent of the students in the school building were ill, and 15 households had secondary cases. Installing liquid soap in dispensers in student restrooms was the initial control measure, followed by sustained instruction in hand washing, scheduled hand washing times, and monitored cleaning and disinfection procedures for surfaces and inanimate objects. Enhanced surveillance detected no new cases in the school district. CONCLUSIONS: Appropriate soap supplies and repeated instruction in hand washing and its monitoring were needed to control the outbreak.

COVID-19 and contamination: impact on exposures to alcohol-based hand sanitizers reported to Texas Poison Control Centers, 2020.

BACKGROUND: The COVID-19 pandemic has increased use of alcohol-based hand sanitizers (ABHS), creating shortages leading to additional production by new, non-traditional manufacturers. In June 2020, the Food and Drug Administration (FDA) issued warnings about methanol or 1-propanol contaminated brands of hand sanitizer. Exposure to methanol, including dermally, can cause kidney damage, blindness and death. Exposure to 1-propanol can cause severe acidosis and death. Chronic exposure may be more likely due to increased hand sanitizer use in 2020. METHODS: We used generic codes for ABHS to characterize exposures reported to the Texas Poison Control Network in 2019 and 2020. For 2020 cases, we also used case narratives to identify cases considered COVID-19 -related and cases where the caller reported exposure to unknown ABHS with safety concerns, specifically identified brands on the FDA warning list or before that warning was made in June 2020. RESULTS: Reported exposures to ABHS increased 72.5% between 2019 and 2020. In 2020, 10% of the cases were COVID-19 -related. COVID-19 -related cases in 2020 were likely to be older, to have a lower portion of young children exposed and to report chronic use of hand sanitizer. Similar trends were reported among cases who reported possible exposures to potentially unsafe ABHS products, including products on the FDA list. Most exposures were not referred for medical attention, and no deaths were reported among the Texas cases. DISCUSSION: Callers reporting exposures to ABHS related to use prompted by the novel severe acute respiratory syndrome coronavirus 2 (COVID-19) and specific exposure to unsafe products differ from the traditional callers in being older, reporting chronic use and in healthcare facility (HCF) referral. The 72.5% increase in 2020 calls compared to 2019 cases differ from typical exposures, which often involve young children. Changes in manufacturing processes by additional manufacturers have produced potential exposure to toxic alcohol-containing products and others in Texas.

Pertussis in Florida, 2000-2006: trends in a historically low-incidence state.

OBJECTIVE: Florida, the fourth most populous state in the nation, has had historically low incidence rates of pertussis, the only vaccine-preventable disease with increasing numbers of reported cases. We compared the epidemiology and incidence rates of pertussis in Florida with other states and the United States. METHODS: We used Florida and federal surveillance data from 2000 through 2006. RESULTS: Reported incidence of pertussis in Florida, numbers of cases, and proportions of adolescents and adults all increased during the seven-year study period. Florida incidence rates increased from 0.44 to 1.28, but the state's incidence was always ranked 45th or lower among the states. Reported pertussis cases and those among adolescents and adults in Florida increased during the study period. Ten counties, containing 60% of Florida's population, reported two-thirds of the state's cases. CONCLUSIONS: Pertussis reported from Florida mirrored national trends with increasing incidence, numbers of cases, and proportions of adolescent and adult cases. Despite the increases, Florida maintained its historic pattern of pertussis incidence rates that are consistently lower than national figures. Limited laboratory diagnostics and a focus on the pediatric population likely contributed to the lower rates of pertussis in Florida. More emphasis on surveillance of adolescent and adult cases is needed.

Carbon monoxide poisoning in Florida during the 2004 hurricane season.

BACKGROUND: During August-September 2004, four major hurricanes hit Florida, resulting in widespread power outages affecting several million households. Carbon monoxide (CO) poisonings during this period were investigated to identify ways to prevent future poisoning. METHODS: Medical records from ten hospitals (two with hyperbaric oxygen chambers) were reviewed to identify individuals diagnosed with unintentional CO poisoning between August 13 and October 15, 2004. Multiple attempts were made to interview one person from each nonfatal incident. Medical examiner records and reports of investigations conducted by the U.S. Consumer Product Safety Commission of six fatal poisonings from five additional incidents were also reviewed. RESULTS: A total of 167 people treated for nonfatal CO poisoning were identified, representing 51 incidents. A portable, gasoline-powered generator was implicated in nearly all nonfatal incidents and in all fatal poisonings. Generators were most often located outdoors, followed by inside the garage, and inside the home. Telephone interviews with representatives of 35 (69%) incidents revealed that concerns about theft or exhaust most often influenced the choice of location. Twenty-six (74%) households did not own a generator before the hurricanes, and 86% did not have a CO detector at the time of the poisoning. Twenty-one (67%) households reported reading or hearing CO education messages before the incident. CONCLUSIONS: Although exposure to public education messages may have encouraged more appropriate use of generators, a substantial number of people were poisoned even when the devices were operated outdoors. Additional educational efforts and engineering solutions that reduce CO emission from generators should be the focus of public health activities.

Tuberculosis skin testing among HIV-infected pregnant women in Miami, 1995 to 1996.

OBJECTIVE: Approximately 6000 women deliver annually at Jackson Memorial Hospital in Miami, where 2.4% of women has human immunodeficiency virus (HIV) and 60% is foreign-born. We conducted a retrospective review of prenatal records among HIV-infected women to evaluate tuberculin skin testing (TST). STUDY DESIGN: We determined how many women had TSTs placed and read, and the TST results. RESULTS: We identified 207 HIV-infected women, 87% of such women delivering in 1995 to 1996. Most did not know their HIV status before seeking prenatal care (109, 54%) and most (176, 85%) had TSTs done. Of the women, 45 had positive TSTs, 96 had negative TSTs, and 35 were anergic. Most results were not recorded using millimeters of induration. Two women (1%) had active tuberculosis (TB) disease. CONCLUSION: Overall, 21% of all HIV-infected women had positive TSTs and 1% had active TB disease. Focused TB skin testing should be part of routine prenatal care in clinics serving populations at high-risk for TB, such as those with HIV infection and the foreign-born.

Use of birth certificates and surveillance data to characterize reported pertussis among Texas infants and young children, 1995 to 2000.

BACKGROUND: Pertussis morbidity is increasing, especially among young infants and children, who are more likely to be hospitalized and have more severe complications. Maternal and pediatric factors associated with underimmunization and hospitalization for pertussis are poorly understood, but young maternal age and low birth weight have been associated with pertussis among young infants. METHODS: We used pertussis surveillance data, matching cases to the birth certificates of 416 Texas infants and children reported as pertussis cases during 1995 to 2000. Maternal/pediatric information gathered from birth certificates included birth weight, gestational age, and maternal factors (age, birthplace and education level, prenatal care, and previous live births). We assessed the immunization status of the cases and maternal/pediatric factors associated with underimmunization with a pertussis-containing vaccine and hospitalization using descriptive statistics and logistic regression. RESULTS: The 416 cases represented 20% of the pertussis morbidity in Texas from 1995 through 2000. Most children had not been vaccinated (275 [66%]), even though 374 (90%) were old enough for at least one dose. Among those 374 children, only those younger than 6 months were associated with underimmunization (odds ratio [OR], 9.98; 95% confidence interval [CI], 6.24-15.97). Most patients (253 [61%]) were hospitalized. Hospitalization was associated with complications of apnea (OR, 2.13; 95% CI, 1.39 2.38), pneumonia (OR, 5.26; 95% CI, 2.94-11.59), and age younger than 6 months (OR, 2.11; 95% CI, 1.38-3.23). CONCLUSION: More than two-thirds of the children reported as pertussis cases were old enough to have at least one dose of a pertussis-containing vaccine but were not immunized. Maternal and pediatric characteristics on birth certificates were not useful in predicting either underimmunization or hospitalization for pertussis complications. More current assessments of maternal and pediatric characteristics should be part of pertussis contact investigations.

Evaluating acceptability and completeness of overseas immunization records of internationally adopted children.

BACKGROUND: Increasing numbers of families in the United States are adopting children who were born in other countries. Appropriate immunization of internationally adopted children provides a challenge to pediatricians who must evaluate documentation of vaccines administered overseas and fulfill the recommended US childhood immunization schedule. The acceptability of vaccinations received outside the United States was addressed by the Advisory Committee on Immunization Practices in 1994, but few population-based studies assessing these vaccinations have been reported. METHODS: We performed a retrospective cohort study of 504 children who were adopted from other countries and evaluated in 1997 and 1998. Our goal was to determine the acceptability of overseas vaccinations for meeting US immunization requirements. We assessed immunization records for both valid documentation of receipt of vaccine and comparability with the recommended US schedule. We also determined the number of children who were up to date (UTD) for diphtheria-tetanus-pertussis, polio, hepatitis B, and measles-mumps-rubella vaccines under the US schedule. RESULTS: The children's mean age at initial US evaluation was 19 months; 71% were girls, and most (88%) had resided in orphanages. They were adopted from 16 countries, most frequently from China (48%) and Russia (31%). Thirty-five percent (178) of children had overseas immunization records, 167 (94%) of which were considered valid. Most children with valid records (112 [67%] of 167) were UTD for 1 or more vaccine series under the US schedule. CONCLUSION: The majority (65%) of internationally adopted children had no written records of overseas immunizations. Among the 178 children with documented overseas immunizations, 167 (94%) had valid records and some vaccine doses that were acceptable and UTD under the US schedule. Additional research and more specific guidance in the most cost-effective approaches to evaluation of overseas vaccinations are needed to ensure appropriate state-side vaccination and to improve the health of these children and their communities.