Sexually Transmitted Infections Among Incarcerated Women: Findings From a Decade of Screening in a Los Angeles County Jail, 2002–2012

Objectives. We describe and report findings from a screening program to identify sexually transmitted infections (STIs) and HIV among female inmates in Los Angeles County Jail.Methods. Chlamydia and gonorrhea screening was offered to entering female inmates. Women were eligible if they were (1) aged 30 years or younger, or (2) pregnant or possibly pregnant, or (3) booked on prostitution or sex-related charges. Voluntary syphilis and HIV testing was offered to all women between 2006 and 2009. This analysis reports on data collected from 2002 through 2012.Results. A total of 76 207 women participated in the program. Chlamydia prevalence was 11.4% and gonorrhea was 3.1%. Early syphilis was identified in 1.4% (141 of 9733) and the overall prevalence of HIV was 1.1% (83 of 7448). Treatment levels for early syphilis and HIV were high (99% and 100%, respectively), but only 56% of chlamydia and 58% of gonorrhea cases were treated.Conclusions. Screening incarcerated women in Los Angeles County revealed a high prevalence of STIs and HIV. These inmates represent a unique opportunity for the identification of STIs and HIV, although strategies to improve chlamydia and gonorrhea treatment rates are needed.The ability of correctional facilities to provide access to medically underserved and otherwise marginalized populations makes them an ideal location for health screening and prevention measures, representing an important public health opportunity.1–3 Populations passing through correctional facilities represent a group that is at increased risk for sexually transmitted infections (STIs), including HIV, as the prevalence of risk factors such as substance use, transactional sex, previous history of an STI, and inconsistent condom use with multiple partners is high.3–6 Furthermore, in some instances correctional facilities have noted higher prevalence of STIs and HIV than other institutions (e.g., sexual health clinics) serving high-risk clients. Studies of STI prevalence conducted in jails have revealed relatively high prevalence of chlamydia among inmates ranging from 7% to 22%, with gonorrhea prevalence ranging from less than 1% to 9%.7–10 Likewise, the prevalence of HIV among jail inmates is relatively high with an estimated 1.2% to 1.8% infected, compared with 0.3% in the US general population.11,12 In fact, modeling data suggests that approximately 14% of persons living with HIV pass through a correctional facility in their lifetime, with the proportion being as high as 20% among African Americans and Hispanics.13Beyond reducing the disease burden in correctional facilities, the potential community-level benefits from programs aimed at STI and HIV prevention, screening, and treatment are substantial.8,11,12,14–16 An examination of community-level chlamydia prevalence following the establishment of a jail screening program in San Francisco, California, revealed a significant decline in chlamydia positivity among young women testing at community clinics serving a population with high incarceration rates.8 Specifically, the authors noted that chlamydia positivity among female attendees at a clinic located in a neighborhood in which the prevalence of jail testing was high declined from 16% in 1997 to 8% in 2004, while no changes occurred in a clinic located in a neighborhood with low jail testing (5% in 1997 and 5% in 2004).8 The potential community-level impact of STI screening services has been noted in other jail settings.14,15 In New York City, implementation of universal screening for men aged 35 years and younger entering jail resulted in a 59% increase in citywide reported male chlamydia case rate and the adult jails identified and reported 40% more cases than all 10 New York City public STI clinics.15 The population-level impact of jail screening is also supported by modeling data, which suggest that the community prevalence of chlamydia can be reduced by up to 54% by using jail-based chlamydia screen-and-treat programs.16Despite the fact that correctional facilities serve populations that are at increased risk for STIs, screening services in jails are limited.17,18 Potential reasons for this are manifold, and include the competing agendas of security and control versus health and welfare, as well as other logistical concerns including staffing, space, and rapid turnover of inmates in jail settings.1,17 However, jail-based STI and HIV interventions could potentially have a significant public health impact. Jails, which are most often run by sheriff departments or local governments, are designed to hold individuals awaiting trial or serving short sentences. As such, a much larger number of people cycle through jails than through prisons with more than 12 million admissions in the United States in 2012 compared with nearly 700 000 for prisons.19,20 Recognizing an important public health opportunity, the Los Angeles County Sheriff’s Department (LASD) in California developed a partnership with the Los Angeles County Department of Public Health (DPH) to offer STI screening for female inmates in the Los Angeles County Jail—the largest jail system in the United States.21 The objective of this report is to describe our experience and report findings from this screening program among women incarcerated in the Los Angeles County Jail from 2002 to 2012.     

Evaluation of a universal hepatitis B vaccination program and antenatal screening for hepatitis B surface antigen: Results from a real-world study 2015–2016

Background and AimsUniversal vaccination against hepatitis B virus (HBV) in infancy was implemented in Israel in 1992. This population-based study aimed to evaluate the coverage rate and cost-benefit of the HBV vaccination program among infants in Israel and the Hepatitis B surface antigen (HBsAg) status in their mothers.MethodsUsing the database of a health maintenance organization with 2 million members, we retrospectively identified, all the infants born in 2015–2016 and their mothers. Maternal data collected included age, ethnicity, country of birth and HBsAg status during pregnancy. HBV vaccination coverage among infants was calculated. A cost-benefit analysis of the HBV vaccination program was conducted based on the actual costs of HBV infection treatments in all HBsAg positive mothers.ResultsOur cohort included 72,792 mothers who gave birth to 77,572 live infants. A total of 71,107 (97.7%) mothers were screened for HBV during pregnancy, of them 124 (0.2%), who gave birth to 132 infants were HBsAg positive. HBV vaccination coverage rates were 94%, 93% and 89%, for the first, second and third dose, respectively. Birth dose coverage of 95% among infants born to HBsAg positive mothers was significantly higher compared to HBsAg negative or unscreened mothers (p < 0.001). The percentage of HBsAg positivity among mothers who were born in Israel, the Former Soviet Union or Ethiopia, were 0.1%, 0.8% and 5%, respectively (p < 0.001). Ethnic differences were not found between HBsAg positive and HBsAg negative mothers. Calculated benefit-to-cost ratios were 1.24:1 and 4.15:1, with and without antenatal HBsAg screening, respectively.ConclusionsThe Israeli vaccination program against HBV infection is epidemiologically and economically justified. High coverage rates among infants born to HBsAg positive mothers reflect very good adherence to the vaccination program and antenatal screening. Higher HBsAg positivity rates among immigrant mothers identify a high-risk population for HBV infection.     

Using Population Reach as a Proxy Metric for Intervention Impact to Prioritize Selection of Obesity Prevention Strategies in Los Angeles County, 2010–2012

Recent federal initiatives have used estimates of population reach as a proxy metric for intervention impact, in part to inform resource allocation and programmatic decisions about competing priorities in the community. However, in spite of its utility, population reach as a singular metric of intervention impact may be insufficient for guiding multifaceted program decisions. A more comprehensive, validated approach to measure or forecast dose may complement reach estimates to inform decision makers about optimal ways to use limited resources.Although federal initiatives in obesity prevention have typically recommended the use of evidence-based community strategies,1 less is known about the level of impact that these strategies can contribute to improving health in the real world. The absence of this type of practice-based information often poses significant challenges to funding agencies and program planners that are tasked with prioritizing and selecting intervention strategies for a city or community. Given that this information is not readily available or regularly reported, recent federal initiatives have begun to request data on intervention impact, using estimates of population reach as a proxy metric for predicting the extent of intervention effectiveness. The Centers for Disease Control and Prevention, for example, recently provided guidance on how to measure and report reach for a range of obesity prevention interventions focused on improving systems and environments in cities and communities across the United States.2 They broadly defined “reach” as the number of unique individuals affected by a program initiative and further refined this concept to include direct reach as the number of unique individuals exposed to the intervention in some way and indirect reach as the number of unique individuals indirectly exposed to the intervention in some way but who are not residents of a targeted community (e.g., visitors).2 To provide more specificity, other agencies and organizations (e.g., the Center for Community Health and Evaluation) have sought to account for the effects of community health interventions by incorporating intervention dose as an additional parameter for consideration in their priority-setting process and program planning.3 In this context, “dose” has been defined as the product of reach (percentage of people exposed to an intervention) and strength (the degree to which people reached by the intervention changed their health behaviors).3 Although dose is a more robust measure of intervention impact, reach is generally easier to estimate and use, given the time constraints and limited availability of relevant data sources to local leaders who must make daily decisions about policy development, program implementation, and operations. It is important to note, however, that the Centers for Disease Control and Prevention and the Center for Community Health and Evaluation differ in their definitions of “reach.” Although the former’s definition distinguishes between direct and indirect number of unique individuals, the latter’s does not, making comparisons of this metric across studies, interventions, places, settings, and times difficult to achieve.Although the aforementioned metrics (reach and dose) can provide meaningful data to inform health and public health decisions,4,5 few strategic planning efforts have incorporated their use in the prioritization process.6 In this article, we describe the effort of the Los Angeles County Department of Public Health (DPH) to systematically incorporate population reach as a proxy metric of intervention impact, using it to guide prioritization of system and environmental change strategies for community implementation (when appropriate). The motivation for writing this article is to inform the efforts of other agencies similarly tasked with addressing the obesity epidemic in their communities but often constrained by limited resources and several competing priorities in their jurisdictions.     

Impact of an accelerated measles-mumps-rubella (MMR) vaccine schedule on vaccine coverage: An ecological study among London children, 2012–2018

BackgroundVaccination coverage of dose two of MMR (MMR2) at 5th birthday has been consistently low in London and measured 76.3% in 2018/19. Since the early 2000s seven boroughs in London started offering dose two earlier, from 15 to 18 months onwards instead of the recommended 3 years 4 months. In this study we investigate whether the accelerated schedule of MMR2 leads to a change in coverage of MMR2 and other childhood vaccines with an ecological study using childhood immunisation data from 2009 to 2018 in London.MethodsWe modelled coverage used generalized estimating equations (GEE) adjusted for year and DTaP/IPV/Hib3 coverage measured at 2nd birthday as a proxy for baseline local vaccination programme performance to determine the percentage point difference in coverage of MMR2 and other childhood vaccines.ResultsAverage MMR2 coverage was higher among early implementing boroughs from 2012/13 onwards. Coverage difference was highest in 2017/18 (9.2 percentage points, 95% CI 4.8, 13.5, p < 0.001). On average over the 6 years, compared to London boroughs on the routine schedule, MMR2 coverage among early implementing boroughs was 3.3 percentage points higher (95% CI 1.3, 5.3, p = 0.01) after adjusting for DTaP/IPV/Hib3 coverage, IMD score and year.ConclusionEarlier vaccination of MMR2 is associated with significantly higher coverage at five years for this vaccine in London. Further research is needed to assess the association at a more granular level, but our findings underline a potential opportunity to increase MMR coverage.     

Prevalence of diagnosed chronic hepatitis B infection among U.S. Medicaid enrollees, 2000–2007

PurposeFew population-based studies have estimated the number of persons diagnosed with chronic hepatitis B (CHB) infection in the United States. Our objective was to estimate the prevalence of diagnosed CHB infection among persons enrolled in the U.S. Medicaid programs of California, Florida, New York, Ohio, and Pennsylvania between 2000 and 2007. As part of our analyses, we confirmed the accuracy of CHB diagnoses within the Medicaid database.MethodsCHB infection was defined by the presence of two outpatients CHB diagnoses recorded more than 6 months apart. Two clinicians reviewed the medical records of a random sample of patients who met this definition to confirm the diagnosis, which enabled calculation of the positive predictive value (PPV). The period prevalence of diagnosed CHB infection among Medicaid enrollees with at least 6 months of membership from 2000 to 2007 was then estimated, adjusting for both the PPV and estimated sensitivity of our definition of CHB infection.ResultsThe definition of CHB infection accurately identified clinician-confirmed cases (PPV, 96.3%; 95% confidence interval [CI], 87.3–99.5). Using this definition, 31,046 cases of CHB were diagnosed among 31,358,010 eligible Medicaid members from the five states (prevalence, 9.9 [95% CI, 9.8–10.0] per 10,000). Adjusting for the PPV and estimated sensitivity of our CHB definition, the prevalence of diagnosed CHB infection was 15.6 (95% CI, 15.4–15.7) per 10,000.ConclusionsTwo outpatient CHB diagnoses recorded more than 6 months apart validly identified clinician-confirmed CHB. The prevalence of diagnosed CHB infection among U.S. Medicaid enrollees was 15.6 per 10,000.     

A cost–benefit analysis of blood donor vaccination as an alternative to additional DNA testing for reducing transfusion transmission of hepatitis B virus

A survey-based, cost–benefit analysis was performed comparing blood screening strategies with vaccination strategies for the reduction of transfusion transmission of HBV. 231 whole blood donors and 126 apheresis donors were eligible and completed a questionnaire detailing their donation habits. The cost–benefit analysis included current mandatory HBV testing (HbsAg + anti-Hbc, A1), A1 with additional nucleic acid testing (NAT) for minipool (A2) or individual donation testing (A3), as well as HBV vaccination strategies using time-dependant (B1) or titre dependent booster vaccination solely (B2), or B2 in addition to current mandatory testing procedures (B3). Different cost models were applied using a 5% rate of discount.Absolute costs for current mandatory testing procedures (A1) over 20 years in Germany were €1009 million. Additional NAT would lead to incremental costs of 43% (A2) or 339% (A3), respectively. Vaccination strategies B1 and B2 showed cost-reductions relative to A1 of 30% and 14%, respectively. The number of remaining HBV infections could be reduced from 360 (for A1) to 13, using vaccination, compared with 144 or 105 remaining infections for A2 or A3, respectively. Absolute cost per prevented infection is similar (€2.0 million) for A2 and B3. HBV vaccination offers the near-elimination of transfusion infections while representing a potential cost-reduction.     

Self-reported hepatitis A vaccination as a predictor of hepatitis A virus antibody protection in U.S. adults: National Health and Nutrition Examination Survey 2007–2012

ObjectivesTo estimate the predictive value of self-reported hepatitis A vaccine (HepA) receipt for the presence of hepatitis A virus (HAV) antibody (anti-HAV) from either past infection or vaccination, as an indicator of HAV protection.MethodsUsing 2007–2012 National Health and Nutrition Examination Survey data, we assigned participants to 4 groups based on self-reported HepA receipt and anti-HAV results. We compared characteristics across groups and calculated three measures of agreement between self-report and serologic status (anti-HAV): percentage concordance, and positive (PPV) and negative (NPV) predictive values. Using logistic regression we investigated factors associated with agreement between self-reported vaccination status and serological results.ResultsDemographic and other characteristics varied significantly across the 4 groups. Overall agreement between self-reported HepA receipt and serological results was 63.6% (95% confidence interval [CI] 61.9–65.2); PPV and NPV of self-reported vaccination status for serological result were 47.0% (95% CI 44.2–49.8) and 69.4% (95% CI 67.0–71.8), respectively. Mexican American and foreign-born adults had the highest PPVs (71.5% [95% CI 65.9–76.5], and 75.8% [95% CI 71.4–79.7]) and the lowest NPVs (21.8% [95% CI 18.5–25.4], and 20.0% [95% CI 17.2–23.1]), respectively. Young (ages 20–29 years), US-born, and non-Hispanic White adults had the lowest PPVs (37.9% [95% CI 34.5–41.5], 39.1% [95% CI, 36.0–42.3], and 39.8% [36.1–43.7]), and the highest NPVs (76.9% [95% CI 72.2–81.0, 78.5% [95% CI 76.5–80.4)], and 80.6% [95% CI 78.2–82.8), respectively. Multivariate logistic analyses found age, race/ethnicity, education, place of birth and income to be significantly associated with agreement between self-reported vaccination status and serological results.ConclusionsWhen assessing hepatitis A protection, self-report of not having received HepA was most likely to identify persons at risk for hepatitis A infection (no anti-HAV) among young, US-born and non-Hispanic White adults, and self-report of HepA receipt was least likely to be reliable among adults with the same characteristics.     

Associations of Neighborhood Concentrated Poverty,Neighborhood Racial/Ethnic Composition,and Indoor Allergen Exposures: a Cross-Sectional Analysis of Los Angeles Households, 2006–2008

Although racial/ethnic, socioeconomic, and neighborhood factors have been linked to asthma, and the association between indoor allergens and asthma is well documented, few studies have examined the relationship between these factors and indoor allergens. We examined the frequency of reported indoor allergens and differences by racial/ethnic, socioeconomic, and neighborhood characteristics among a diverse sample of Los Angeles households. Multilevel logistic regression models were used to analyze the data from 723 households from wave 2 of the Los Angeles Family and Neighborhood Survey. The reported presence of rats, mice, cockroaches, mold, pets, and tobacco smoke were the primary outcomes of interest. Hispanic and Asian households had a nearly threefold increase in the odds of reporting cockroaches compared to non-Hispanic Whites (OR, 2.85; 95 % CI 1.38–5.88 and OR, 2.62; 95 % CI 1.02–6.73, respectively) even after adjusting for socioeconomic factors. Primary caregivers who had obtained a high school degree were significantly less likely to report the presence of mice and cockroaches compared to primary caregivers with less than a high school degree (OR, 0.19; 95 % CI 0.08–0.46 and OR, 0.39; 95 % CI 0.23–0.68, respectively). Primary caregivers with more than a high school degree were also less likely to report the presence of rats, mice, and cockroaches within their households, compared to those with less than a high school degree. Compared to renters, home owners were less likely to report the presence of mice, cockroaches, and mold within their households. At the neighborhood level, households located within neighborhoods of high concentrated poverty (where the average poverty rate is at least 50 %) were more likely to report the presence of mice and cockroaches compared to households in low concentrated poverty neighborhoods (average poverty rate is 10 % or less), after adjusting for individual race/ethnicity and socioeconomic characteristics. Our study found evidence in support of neighborhood-level racial/ethnic and socioeconomic influences on indoor allergen exposure, above and beyond individual factors. Future studies should continue to explore individual and neighborhood-level racial/ethnic and socioeconomic differences in household allergen exposures across diverse contexts.     

Assessment of the timely administration of the hepatitis B and BCG birth dose and the primary infant vaccination schedule in 2015–2016 in the Mekong Delta,Viet Nam

IntroductionVietnam is implementing hepatitis B (HBV) birth dose (BD) vaccination since 2003 but coverage remains low, especially in the Mekong River Delta. This study aimed to determine the coverage of the HBV BD vaccination, to identify socio-demographic factors influencing HBV BD, and to assess reasons for non-immunization of neonates.MethodsA cross-sectional survey was conducted in 2015–2016. Mothers from 526 children aged 6–11 months living in 3 provinces in the Mekong River Delta - representing respectively urban, rural and remote area - were interviewed at home and infant vaccination documents were checked. The three-stage sampling method was adapted from WHO 30-cluster sampling. Predictors of HBV BD administration were identified with multiple regression analysis.ResultsThe overall HBV BD coverage (within 24 h) was 46.6% (compared to 44.5% for BCG) and was significantly higher in remote or rural than in urban area (OR 1.87 and 3.36, respectively), and in children whose father had a higher educational level (OR 2.76; 2.29 and 1.86, respectively, for master degree, bachelor and secondary school) as compared to a lower level. Main reasons for not having received HBV BD mentioned by parents were vaccines not offered by health care workers (53.0%), and illness of the infant (27.2%).ConclusionAlthough Vietnam started HBV BD vaccination more than 10 years ago, the coverage and timeliness need to improve to reach WHO targets (95% within 24 h after birth). Better training and information of health care workers, and better protocols ensuring timely HBV BD could address these vaccine administration thresholds.     

Hepatitis A vaccination coverage among adults 18–49 years traveling to a country of high or intermediate endemicity,United States

Background

Since 1996, hepatitis A vaccine (HepA) has been recommended for adults at increased risk for infection including travelers to high or intermediate hepatitis A endemic countries. In 2009, travel outside the United States and Canada was the most common exposure nationally reported for persons with hepatitis A virus (HAV) infection.

Objective

To assess HepA vaccination coverage among adults 18–49 years traveling to a country of high or intermediate endemicity in the United States.

Methods

We analyzed data from the 2010 National Health Interview Survey (NHIS), to determine self-reported HepA vaccination coverage (≥1 dose) and series completion (≥2 dose) among persons 18–49 years who traveled, since 1995, to a country of high or intermediate HAV endemicity. Multivariable logistic regression and predictive marginal analyses were conducted to identify factors independently associated with HepA vaccine receipt.

Results

In 2010, approximately 36.6% of adults 18–49 years reported traveling to high or intermediate hepatitis A endemic countries; among this group unadjusted HepA vaccination coverage was 26.6% compared to 12.7% among non-travelers (P-values < 0.001) and series completion were 16.9% and 7.6%, respectively (P-values < 0.001). On multivariable analysis among all respondents, travel status was an independent predictor of HepA coverage and series completion (both P-values < 0.001). Among travelers, HepA coverage and series completion (≥2 doses) were higher for travelers 18–25 years (prevalence ratios 2.3, 2.8, respectively, P-values < 0.001) and for travelers 26–39 years (prevalence ratios 1.5, 1.5, respectively, P-value < 0.001, P-value = 0.002, respectively) compared to travelers 40–49 years. Other characteristics independently associated with a higher likelihood of HepA receipt among travelers included Asian race/ethnicity, male sex, never having been married, having a high school or higher education, living in the western United States, having greater number of physician contacts or receipt of influenza vaccination in the previous year. HepB vaccination was excluded from the model because of the significant correlation between receipt of HepA vaccination and HepB vaccination could distort the model.

Conclusions

Although travel to a country of high or intermediate hepatitis A endemicity was associated with higher likelihood of HepA vaccination in 2010 among adults 18–49 years, self-reported HepA vaccination coverage was low among adult travelers to these areas. Healthcare providers should ask their patients’ upcoming travel plans and recommend and offer travel related vaccinations to their patients.     

Antibody kinetics among 8–10 years old respondents to hepatitis B vaccination in a low endemic country and the effect of a booster dose given 5 or 10 years later

Few data are available concerning the persistence of anti-HBs and the effect of booster doses given several years post-vaccination against hepatitis B during preadolescence. The objective of this open-labelled clinical trial was to evaluate the persistence of antibodies after vaccination with three paediatric doses of Engerix-B at the age of 8–10 years and the effect of a booster dose given 5 (Group Y5) or 10 (Group Y10) years later. Anti-HBs were measured before and one month post-primary vaccination, then 5 and 10 years later, before the booster dose, as well as one month and 1 year post-booster. The anamnestic response was defined as a ≥fourfold increase of anti-HBs post-booster (≥10 IU/L) when compared to pre-booster. Ten years post-primary vaccination, 559 of the 652 initially randomized subjects (86%) were eligible for analysis. Group Y5, 5 years post-booster results: 99% of subjects had detectable levels of antibodies and 96% a titer ≥10 IU/L. The anti-HBs GMTs decreased from 114,489 IU/L one month post-booster to 3354 IU/L 5 years later. Group Y10 results: 10 years post-primary vaccination 96% of subjects had a detectable level of anti-HBs and 85% were above the threshold of 10 IU/L. The GMTs one month post-booster were 31,030 IU/L. The challenge with a booster demonstrated an anamnestic response in 99% of subjects in group Y5 and 100% of subjects in group Y10. All subjects were anti-HBc negative. The booster doses were well tolerated. The excellent anamnestic response observed after the booster dose demonstrates the persistence of immunity in virtually all young adults vaccinated at the age of 8–10 with three paediatric doses of Engerix-B.     

Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: A systematic review of published literature, 2007–2012

Vaccine “hesitancy” is an emerging term in the literature and discourse on vaccine decision-making and determinants of vaccine acceptance. It recognizes a continuum between the domains of vaccine acceptance and vaccine refusal and de-polarizes previous characterization of individuals and groups as either anti-vaccine or pro-vaccine.     

Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

BackgroundThe combined hexavalent diphtheria–tetanus–pertussis–hepatitis B-inactivated poliomyelitis – Haemophilus influenzae type b conjugate vaccine (Infanrix hexa™; DTPa-HBV-IPV/Hib: GlaxoSmithKline Vaccines) induces robust responses to the HBV component when administered at 3, 5 and 11–12 months of age. We assessed long term HBV antibody persistence 10–11 years after primary vaccination in infancy.MethodsAntibody persistence and immune memory were assessed post-primary vaccination at 3, 5, 11–12 months with DTPa-HBV-IPV/Hib, or monovalent HBV vaccine (Engerix™ B, GlaxoSmithKline Vaccines) co-administered with DTPa-IPV/Hib (Infanrix™-IPV/Hib, GlaxoSmithKline Vaccines) in 185 children aged 11–12 years. Blood samples were collected before and 1 month after a challenge dose of Engerix™ B (10 μg dose).Results10–11 years after primary vaccination the percentage of subjects with persisting anti-HBs antibody concentrations ≥10 mIU/ml was 48.4% in the DTPa-HBV-IPV/Hib group and 58.4% in the DTPa-IPV/Hib + HBV group. After the HBV challenge dose, the percentage with anti-HBs ≥100 mIU/ml increased from 14.7% to 93.6% in the DTPa-HBV-IPV/Hib group and 19.1% to 94.4% in the DTPa-IPV/Hib + HBV group. Anti-HBs GMCs increased by at least 187-fold in each group. An anamnestic response (≥4-fold increase in initially seropositive or anti-HBs concentration ≥10 mIU/ml in initially seronegative subjects) was observed in 96.8% and 96.6% of subjects in the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV groups, respectively. No serious adverse events occurred that were considered related to challenge vaccination.ConclusionAdministration of HBV as part of a combination vaccine or as a monovalent vaccine induced long lasting immune memory against HBV in children primed at 3, 5 and 11 months of age. Antibody persistence and immune memory were similar, suggesting that protection afforded by DTPa-HBV-IPV/Hib and monovalent HBV vaccines, is likely to be of similar duration. The administration of HBV challenge dose 10–11 years after the 3, 5, 11–12 months primary schedule induced strong anamnestic responses and was well tolerated.This study is registered at www.clinicaltrials.gov NCT01138098.     

Safety and immunogenicity of a hexavalent diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae b conjugate–hepatitis B vaccine at 2, 3, 4, and 12–14 months of age

Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae b conjugate–hepatitis B virus (DTaP–IPV–Hib–HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12–14 months of age. The formulations contained identical DTaP and IPV components, differing in the contents of Hib polyribosylribitol phosphate (PRP) conjugate component (tetanus-toxoid [PRP-T, 12 μg] or Neisseria meningitidis outer-membrane-protein-complex [PRP-OMPC, 3 μg or 6 μg]), and in hepatitis B surface antigen (HBsAg, 10 μg or 15 μg). A minimum acceptable postdose 3 antibody response rate was defined by the lower limit of the 95% confidence interval exceeding a prespecified target. Rates of adverse events (AEs) were similar among groups, with a trend for increased solicited injection-site reactions (pain, redness, swelling) with increasing PRP-OMPC and HBsAg concentration. Serious AEs reported by eight subjects were not considered to be vaccine related. All PRP-OMPC formulations met prespecified acceptability criteria for postdose 3 immunogenicity for all antigens: PRP, HBsAg, pertussis, diphtheria, tetanus and polio. Apart from the Hib response, the postdose 3 responses obtained with the PRP-T formulation met the acceptability criterion for each antigen. Postdose 4 responses were acceptable for all antigens in all formulations. All vaccine formulations were well tolerated. The three PRP-OMPC formulations met prespecified immunogenicity criteria, and the one with the lowest PRP-OMPC concentration was selected for further optimization of immunogenicity.     

Impact of live attenuated influenza vaccination programme for healthy children in Northern Ireland: A comparison of seven influenza seasons, 2010/11–2016/17

Seasonal influenza vaccination for healthy children was introduced in Northern Ireland in the 2013/14 flu season, with an initial pilot year involving two specific cohorts, followed by rollout to all children aged 4–11 years in subsequent seasons. This study aimed to examine the impact of that programme on the burden of flu in primary care over the study period 2010/11–2016/17.Two routine indicators were used to measure impact – GP in-hour consultations and out-of-hour calls for influenza and influenza-like-illness (ILI). Analysis was conducted overall and stratified by age; rates in children under 14 years of age to measure direct impact and rates in individuals 14 years and over to measure indirect impact. Seven influenza seasons were included, three pre-programme seasons (2010/11–2012/13: phase 0), one pilot season (2013/14: phase 1), and three post-programme seasons (2014/15–2016/17: phase 2).High uptake of vaccination was observed from the programme introduction, with consistent uptake of over 50% in pre-school age groups and over 75% in primary school age groups. Statistically significant reductions were found in GP in-hours consultations and in out-of-hour calls in phase 2 compared to phase 0, both overall (GP in-hours RR 0.61, 95% CI 0.38–0.98, p = .040; out-of-hours RR 0.51, 95% CI 0.27–0.97, p = .041) and in the under 14 years group (GP in-hours RR 0.38, 95% CI 0.19–0.75, p = .006; out-of-hours RR 0.39, 95% CI 0.19–0.83, p = .014).Our results suggest that there have been reductions in the burden of flu in primary care settings overall and in children aged under 14 years in the seasons since the introduction of healthy children influenza vaccination. Further seasons should be added to subsequent analyses to strengthen this evidence.     

Hepatitis B vaccination: A completed schedule enough to control HBV lifelong?: Milan,Italy, 17–18 November 2011

The Viral Hepatitis Prevention Board (VHPB) organized an international meeting in Milan in November 2011 on the question of whether completing a course of hepatitis B vaccination confers lifelong protection against hepatitis B virus infection and its complications. Presentations covered vaccine efficacy including factors influencing long-term protection; breakthrough infections; the immunological effect of natural boosting; the effectiveness of universal hepatitis B vaccination in different countries, and issues relating to national, regional and global policies on booster vaccination. Findings from four continents were presented at the meeting, with data now extending to follow-up for nearly 30 years after full primary vaccination. The results reported add to the extensive and growing body of knowledge, demonstrating that in spite of subsequent decline and ultimate loss of detectable serum anti-HBs, a full primary course of hepatitis B vaccine confers complete protection against acute clinical disease and chronic hepatitis B infection for long periods of time. Our understanding of the role and functions of T and B cells in protective immunity deepens, although the picture is still complex. A framework for future work in several areas emerged from the meeting, including monitoring and surveillance of vaccination programmes, breakthrough infections, hepatitis B in immigrant populations, and vaccine-escape viral mutants. One further concrete recommendation is the setting up of a working group to standardize definitions on terms such as “immunity”, “protection”, “immune memory”, “non-responders”, “long-term”, “anamnestic response”, “breakthrough” and “vaccine failure”.     

A comprehensive analysis of trends and determinants of HIV/AIDS knowledge among the Bangladeshi women based on Bangladesh Demographic and Health Surveys, 2007–2014

Background

South-Asian countries are considered to be a potential breeding ground for HIV epidemic. Although the prevalence of this incurable disease is low in Bangladesh, women still have been identified as more vulnerable group. The aim of this study is to assess the knowledge about HIV/AIDS: its trends and associated factors among the women in Bangladesh.

Methods

We analysed the nationally representative repeatedly cross-sectional Bangladesh Demographic and Health Surveys (BDHSs) data: 2007, 2011, and 2014. These data were clustered in nature due to the sampling design and the generalized mixed effects model is appropriate to examine the association between the outcome and the explanatory variables by adjusting for the cluster effect.

Results

Overall, women’s knowledge about HIV/AIDS has been decreasing over the years. Education plays the leading role and secondary-higher educated women are 6.6 times more likely to have HIV/AIDS knowledge. The likelihood of knowledge is higher among the women who had media exposure (OR: 1.6) and knowledge on family planning (OR: 2.3). A rural-urban gap is noticed in women’s knowledge about HIV/AIDS and significant improvement has been observed among the rural and media exposed women. Results reveal that age, region, religion, socio-economic status, education, contraceptive use have significant (p<0.01) effects on women’s knowledge about HIV/AIDS.

Conclusion

This study recommends to emphasis more on women’s education, media exposure, and family planning knowledge in strengthening women’s knowledge about HIV/AIDS. In addition, residence specific programs regarding HIV/AIDS awareness also need to be prioritized.

     

Importance of taste,nutrition, cost and convenience in relation to diet quality: Evidence of nutrition resilience among US adults using National Health and Nutrition Examination Survey (NHANES) 2007–2010

Concerns with taste, nutrition, cost, and convenience are said to be key influences on food choices. This study examined the importance of food-related attitudes in relation to diet quality using US national level data. Interactions by socioeconomic status (SES), gender and race/ethnicity were tested. Analyses of 8957 adults from National Health and Nutrition Examination Survey (NHANES 2007–2010) were conducted in 2014–15. Perceived importance of taste, nutrition, cost, and convenience in dietary choices were assessed using 4-point Likert scales. Education and family income-to-poverty ratio (FIPR) were SES indicators. Healthy Eating Index (HEI-2010), a measure of adherence to 2010 dietary guidelines, was the diet quality measure. Survey-weighted regressions examined associations between attitudes and HEI, and tested for interactions. Taste was rated as “very important” by 77.0% of the US adults, followed by nutrition (59.9%), cost (39.9%), and convenience (29.8%). However, it was the perceived importance of nutrition that most strongly predicted HEI (β: + 8.0 HEI scores among “very important” vs. “not at all important”). By contrast, greater importance for taste and convenience had a weak inverse relation with HEI (β: − 5.1 and − 1.5 respectively), adjusting for SES. Significant interactions were observed by race/ethnicity, but not SES and gender. Those who prioritized nutrition during food shopping had higher-quality diets regardless of gender, education and income in the US. Certain racial/ethnic groups managed to eat healthy despite attaching importance to cost and convenience. This is the first evidence of nutrition resilience among US adults using national data, which has huge implications for nutrition interventions.     

Reasons for Rejection of Patient-Reported Outcome Label Claims: A Compilation Based on a Review of Patient-Reported Outcome Use among New Molecular Entities and Biologic License Applications, 2006–2010

ObjectivesPrevious analyses of patient-reported outcome (PRO) label claims concentrated only on successful label claims. The goal of this research was to explore the reasons why PRO label claims were denied and to compile regulatory feedback regarding the use of PROs in clinical trials.MethodsBy using the Food and Drug Administration's Drug Approval Report Web page, all new molecular entities and biologic license applications approved between January 2006 and December 2010 were identified. For identified drug products, medical review sections from publicly available drug approval packages were reviewed to identify PRO end-point status and any Study Endpoints and Label Development team comments.ResultsOf the 116 new molecular entities and biologic license applications with accompanying drug approval packages identified and reviewed, 44.8% of the products included PROs as part of the pivotal studies; however, only 24.1% received PRO label claims. Primary reasons for denial included issues of fit for purpose, issues of study design, data quality or interpretation, statistical issues, administrative issues, and lack of demonstrated treatment benefit.ConclusionsBased on drug approval packages, nearly half (45%) of new molecular entitity/biologic license application products in the years 2006 to 2010 included PROs in the clinical trials supporting their approval, yet this rate is not reflected by claims granted. Understanding the nature of PRO claims granted under the current regulatory guidance is important. In addition, a clear understanding of denied claims yields valuable insight into where sponsors may improve implementation of PROs in clinical trials and submission of PRO evidence to increase the likelihood of obtaining PRO label claims.