Tolerability and antibody response in adolescents and adults revaccinated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) 4-5 years after a previous dose

Background

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine is not currently recommended for adults.

Methods

This open-label, postmarketing, multicenter study evaluated the tolerability and immunogenicity of a second dose of an adult formulation of tetanus, diphtheria, and pertussis vaccine (Tdap) in adolescents and adults 5 years after a first dose.

Results

A total of 545 participants from previous Tdap vaccine studies, ranging in age from 15 to 69 years, participated in this study. Of these participants, 94.2% had at least one solicited adverse event after the booster dose such as injection-site erythema (28.6%), swelling (25.6%), or pain (87.6%) or a systemic adverse event such as myalgia (61.0%), headache (53.2%), malaise (38.2%), or fever (6.5%). These adverse events were slightly more frequent than after the initial dose. Postvaccination, 100% of participants had a tetanus antibody level ≥0.10 IU/mL and 95% had a diphtheria antibody level ≥0.10 IU/mL. For pertussis, 82.1% (pertussis toxoid), 96.7% (filamentous hemagglutinin), 95.6% (pertactin), and 99.8% (fimbriae) had a postvaccination antibody threshold of ≥50 EU/mL.

Conclusion

A second dose of Tdap vaccine 5 years after the initial dose was well tolerated and immunogenic in adolescents and adults.     

Barriers to early uptake of tetanus, diphtheria and acellular pertussis vaccine (Tdap) among adults-United States, 2005-2007

Background

The tetanus, diphtheria and acellular pertussis vaccine (Tdap) was recommended by the Advisory Committee on Immunization Practices (ACIP) for U.S. adults in 2005. Our objective was to identify barriers to early uptake of Tdap among adult populations.

Methods

The 2007 National Immunization Survey (NIS)-Adult was a telephone survey sponsored by the Centers for Disease Control and Prevention (CDC). Immunization information was collected for persons aged ≥18 years on all ACIP-recommended vaccines. A weighted analysis accounted for the complex survey design and non-response.

Results

Overall, 3.6% of adults aged 18-64 years reported receipt of a Tdap vaccination. Of unvaccinated respondents, 18.8% had heard of Tdap, of which 9.4% reported that a healthcare provider had recommended it. A low perceived risk of contracting pertussis was the single most common reason for either not vaccinating with Tdap or being unwilling to do so (44.7%). Most unvaccinated respondents (81.8%) indicated a willingness to receive Tdap if it was recommended by a provider.

Conclusions

During the first two years of availability, Tdap uptake was likely inhibited by a low collective awareness of Tdap and a low perceived risk of contracting pertussis among U.S. adults, as well as a paucity of provider-to-patient vaccination recommendations. Significant potential exists for improved coverage, as many adults were receptive to vaccination.     

Adverse events after Fluzone Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011–2013

Background

In May 2011, the first trivalent inactivated influenza vaccine exclusively for intradermal administration (TIV-ID) was licensed in the US for adults aged 18–64 years.

Objective

To characterize adverse events (AEs) after TIV-ID reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

Methods

We searched VAERS for US reports after TIV-ID among persons vaccinated from July 1, 2011–February 28, 2013. Medical records were requested for reports coded as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis. Clinicians reviewed available information and assigned a primary clinical category to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following TIV-ID. Causality was not assessed.

Results

VAERS received 466 reports after TIV-ID; 9 (1.9%) were serious, including one reported fatality in an 88-year-old vaccinee. Median age was 43 years (range 4–88 years). The most common AE categories were: 218 (46.8%) injection site reactions; 89 (19.1%) other non-infectious (comprised mainly of constitutional signs and symptoms); and 74 (15.9%) allergy. Eight reports (1.7%) of anaphylaxis were verified by the Brighton criteria or a documented physician diagnosis. Disproportional reporting was identified for three AEs: ‘injection site nodule’, ‘injection site pruritus’, and ‘drug administered to patient of inappropriate age’. The findings for the first two AEs were expected. Twenty-four reports of vaccinees <18 years or ≥65 years were reported, and 14 of 24 were coded with the AE ‘drug administered to patient of inappropriate age’.

Conclusions

Review of VAERS reports did not identify any new or unexpected safety concerns after TIV-ID. Injection site reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Use of TIV-ID in younger and older individuals outside the approved age range highlights the need for education of healthcare providers regarding approved TIV-ID use.     

Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose

Background

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine during adulthood is not currently recommended.

Methods

This open-label, multicenter study compared the safety and immunogenicity of a first dose of an adult formulation of tetanus, diphtheria, and acelluar pertussis vaccine (Tdap) with a repeat dose of Tdap in adults who had received Tdap 10 years previously.

Results

A total of 769 participants ranging in age from 20 to 72 years took part in this study; 92.3% of naïve and 92.7% of repeat-dose participants had at least one solicited adverse event. Injection-site pain (84.4% and 87.8%), erythema (29.7% and 23.1%), and swelling (23.3% and 20.5%), and myalgia (53.5% and 60.1%), headache (37.6% and 40.6%), malaise (29.0% and 29.4%), and fever (4.9% and 4.2%) were the most common solicited adverse events reported in the naïve and repeat-dose groups, respectively. Postvaccination antibody levels ≥0.1 IU/mL were achieved by 99.7% of the naïve-group participants and all of the repeat-dose participants for tetanus and 96.1% of the naïve group and 98.5% of the repeat-dose group for diphtheria, both meeting the predefined noninferiority criteria. For pertussis antibodies, anti-PT (89.2 EU/mL vs. 116 EU/mL) was higher in the repeat-dose group, anti-FHA (249 vs. 214) and anti-PRN (216 vs. 266) were similar, and anti-FIM (1015 vs. 779) was higher in the naïve group. Noninferiority criteria were met for all antigens except for anti-FIM.

Conclusion

A repeat dose of Tdap vaccine 10 years after the first dose was well tolerated and immunogenic in adults (ClinicalTrials.gov identifier: NCT00712959).     

Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States,July 2016–June 2018

Background

Trivalent adjuvanted influenza vaccine (aIIV3; Fluad®) was approved in the United States (U.S.) in 2015 for adults aged ≥65?years and has been in use since the 2016–17 influenza season.

Safety review of tetanus toxoid,reduced diphtheria toxoid,acellular pertussis vaccines (Tdap) in adults aged ≥65 years,Vaccine Adverse Event reporting System (VAERS), United States,September 2010–December 2018

IntroductionThe Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group.MethodsWe searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting.ResultsVAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected.ConclusionsWe did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.     

Enhanced surveillance of tetanus toxoid,reduced diphtheria toxoid,and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011–2015

BackgroundIn October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine.ObjectivesWe characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011–2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005–2010).MethodsWe searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/01/2011–6/30/2015) and compared it to published data before the routine Tdap recommendation (01/01/2005–06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation.ResultsWe found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5–2.8%) and injection site reactions/arm pain (4.5–11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7–1%). After the 2011 Tdap recommendation, in most reports, vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports.ConclusionsNo new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.     

U.S. Postlicensure safety surveillance for adolescent and adult tetanus,diphtheria and acellular pertussis vaccines: 2005–2007

Background

Pre-licensure clinical trials for two U.S. licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs).

Methods

To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed).

Results

A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005–June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain–Barré Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia.

Conclusions

Because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important – and reassuring – information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the U.S. licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.     

The safety of immunizing with tetanus–diphtheria–acellular pertussis vaccine (Tdap) less than 2 years following previous tetanus vaccination: Experience during a mass vaccination campaign of healthcare personnel during a respiratory illness outbreak

Background

Tdap is recommended for health care personnel (HCP) aged <65 years who received tetanus diphtheria or tetanus toxoid immunization (Td/TT) ≥2 years earlier. During a medical center Tdap vaccination campaign, we assessed the safety of use of a Td/TT to Tdap interval <2 years in HCP. We also describe reactogenicity in HCP who were aged ≥65 years or pregnant.

Methods

HCP vaccinated with Tdap were surveyed to assess time since last Td/TT (≥2 years vs. <2 years), age, pregnancy status, and injection site adverse events (AEs) during the 2 weeks after Tdap. AE rates were calculated and compared by non-inferiority analysis using a predetermined margin of 10%. We searched clinic logbooks to assess for clinically important adverse events during the 2 months after Tdap.

Results

Of the 4524 vaccinated HCP, 2221 (49.1%) completed a safety survey which met criteria for analysis. Non-inferiority analysis found that rates of moderate and/or severe injection site AEs were not significantly greater in those vaccinated <2 years than in those vaccinated ≥2 years after previous Td/TT. Three serious adverse events were reported during the 2 months after vaccination, none in persons who were ≥65 years, pregnant or received Td/TT <2 years before.

Conclusions

Our findings add to the body of evidence that a short interval between Td/TT and a single dose of Tdap is safe.     

Characteristics associated with the uptake of influenza vaccination among adults in the United States

Objective

Existing data suggest that influenza vaccination rates among adults in the United States fall far short of the Healthy People 2010 goals and the updated Healthy People 2020 targets. We identified characteristics associated with influenza vaccination that might inform strategies for increasing coverage.

Methods

We used data from the 2009 Behavioral Risk Factor Surveillance System to estimate adjusted prevalence ratios for receiving the influenza vaccine in the past 12 months.

Results

Among 134,101 adults aged ≥ 65 years, the influenza vaccination coverage level was 68.9%. Among 286,867 younger adults aged 18-64 years, coverage was markedly lower: 31.8%. Having health care coverage was the strongest predictor of vaccination in both age groups, after accounting for other sociodemographic characteristics, health behaviors, and health status. Those reporting older age, white race, higher education, non-smoking status, being physically active, or having poor physical health or a personal history of various chronic conditions were also more likely to report having received the influenza vaccine.

Conclusion

Our results show clearly that vaccine uptake in the United States is related to social position as well as other health behaviors. These findings call for renewed attention to vaccination strategies to meet the updated Healthy People 2020 goals.     

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

Background

Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) network sought to characterize these SAEs and to assess their possible causal relationship to vaccination.

Methods

Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) physicians reviewed all SAE reports (as defined by the Code of Federal Regulations, 21CFR§314.80) after receipt of H1N1 vaccine reported to VAERS between October 1, 2009 and March 31, 2010. Non-fatal SAE reports with neurologic presentation were referred to CISA investigators, who requested and reviewed additional medical records and clinical information as available. CISA investigators assessed the causal relationship between vaccination and the event using modified WHO criteria as defined.

Results

212 VAERS reports of non-fatal serious neurological events were referred for CISA review. Case reports were equally distributed by gender (50.9% female) with an age range of 6 months to 83 years (median 38 years). The most frequent diagnoses reviewed were: Guillain-Barré Syndrome (37.3%), seizures (10.8%), cranial neuropathy (5.7%), and acute disseminated encephalomyelitis (3.8%). Causality assessment resulted in classification of 72 events as “possibly” related (33%), 108 as “unlikely” related (51%), and 20 as “unrelated” (9%) to H1N1 vaccination; none were classified as “probable” or “definite” and 12 were unclassifiable (6%).

Conclusion

The absence of a specific test to indicate whether a vaccine component contributes to the pathogenesis of an event occurring within a biologically plausible time period makes assessing causality difficult. The development of standardized protocols for providers to use in evaluation of adverse events following immunization, and rapid identification and follow-up of VAERS reports could improve causality assessment.     

A comparative study to evaluate the safety and immunogenicity of two lots of Haemophilus influenzae type-B conjugate vaccine manufactured at different scales

Objective

To compare the immunogenicity and safety of two different lots of SII Haemophilus influenzae type-B-tetanus toxoid conjugate (SII HibP_RO) vaccine manufactured at different scales when given in 3-dose schedule.

Design

Phase IV, open label, comparative, randomized parallel group study.

Setting

Shirdi Sai Baba Hospital, Vadu Budruk, Pune and Pediatrics Department of King Edward Memorial Hospital Research Centre, Pune.

Subjects

204 normal healthy infants of age 6-8 weeks at the time of first vaccination.

Methods

The eligible subjects received 3 doses of 0.5 ml of SII HibP_RO vaccine of either lot depending upon randomization number, intramuscularly in right thigh in the EPI schedule of 6, 10 and 14 weeks. They also received concomitantly DTP-HB vaccine intramuscularly on left thigh and Oral Polio vaccine (OPV). Solicited reactions were captured for 7 days following each vaccination; the events beyond 7 days till day 28 were captured as unsolicited adverse events. Serious Adverse Events (SAEs) were looked for throughout the subject participation. Blood samples were collected at baseline (before the first dose) and one month after the third dose for anti-PRP (polyribosylribitol phosphate) antibodies.

Results

In both groups, more than 98% subjects achieved short-term seroprotection (anti-PRP ≥ 0.15 μg/ml) after 3 doses. The long-term seroprotection (anti-PRP ≥ 1 μg/ml) was 87% and 80% in infants receiving lot manufactured at industrial scale and small scale respectively. Short and long term seroprotection and GMTs increased significantly as compared to baseline in both the groups. Overall local pain (52% and 58%), redness (30% and 41%), swelling (34% and 44%), fever (6% and 6%) and irritability (52% and 50%) were reported in infants receiving lot manufactured at industrial scale and small scale respectively. Majority of the reactions were mild and resoled without any sequelae. Four SAEs, none of them causally related to the study vaccine, occurred during study.

Conclusion

SII HibP_RO vaccines manufactured in small and industrial scale are equally immunogenic, safe and confer adequate seroprotection to infants of 6-14 weeks of age. Scaling up production process has not affected the safety and immune response in the target population.     

Human papillomavirus vaccine initiation among adolescent girls in high-risk communities

Background

We assessed human papillomavirus (HPV) vaccine uptake among adolescent girls, parents’ intentions to vaccinate daughters, and barriers and facilitators of vaccination in a population at elevated risk for cervical cancer.

Methods

Between October 2007 and June 2008, telephone surveys were conducted with randomly selected parents/guardians of 11-18 year old girls attending public middle and high schools serving economically disadvantaged populations in Los Angeles County.

Results

We surveyed 509 predominantly Hispanic (81%) and African American (16%) parents; 71% responded in Spanish. Overall, 23% reported their daughter had received ≥1 dose of HPV vaccine. Although 93% of daughters had seen a doctor in the past year, only 30% reported that a provider recommended HPV vaccine. Characteristics positively associated with odds of having initiated HPV vaccine were having heard of the vaccine (adjusted odds ratio [aOR] 2.6), belief in vaccine effectiveness (aOR 2.9), and doctor recommendation (aOR 48.5). Negative attitudes toward HPV vaccine (aOR 0.2) and needing more information about it (aOR 0.1) were negatively associated with vaccine initiation. Of those with unvaccinated daughters (n = 387), 62% said they “probably/definitely will” vaccinate within the next year and 21% were undecided or didn’t know; only 11% said they definitely won’t.

Conclusions

About one-quarter of adolescent girls in this at-risk community had initiated HPV vaccine by mid-2008. Provider recommendation was the single most important factor associated with vaccination. Because a substantial proportion of parents remain undecided about HPV vaccine, health care providers can play a key role by providing needed information and offering HPV vaccine to all eligible adolescents.     

Assessing the impact of confounding (measured and unmeasured) in a case-control study to examine the increased risk of pandemic A/H1N1 associated with receipt of the 2008-9 seasonal influenza vaccine

Background

This study examines the role of measured and unmeasured confounding in the relationship between the 2008-9 seasonal influenza vaccine and pandemic H1N1 (pH1N1) influenza virus.

Methods

Data were taken from a test-negative case-control study of 462 lab confirmed pandemic A/H1N1 (pH1N1) cases and 484 test-negative controls. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were derived using multivariate logistic regression. The analysis was repeated using propensity matching. A sensitivity analysis was conducted to quantify the impact of a hypothetical unmeasured confounder.

Results

Cases were more likely to have received the seasonal influenza vaccine after adjusting for multiple confounders using multivariate regression (OR 1.82, 95% CI: 1.25-2.65), using propensity matching (OR 1.86, 95% CI: 1.19-2.92) and in subsequent sensitivity analyses. An unmeasured confounder would need a prevalence of 20%, an odds ratio with the vaccine and pH1N1 of ≥3.5 and ≥3.0 (respectively) to result in a non-significant association. Using a prevalence of 40% the respective associations were 3.0 and 2.5.

Conclusion

A significant positive association between the seasonal influenza vaccine and lab confirmed pH1N1 was observed after considering multiple confounders and using different methods for confounder adjustment. This was not likely explained by an unmeasured confounder given the prevalence and strength of association needed to result in a non-significant association.     

Response to 2009 pandemic and seasonal influenza vaccines co-administered to HIV-infected and HIV-uninfected former drug users living in a rehabilitation community in Italy

Background

2009 A(H1N1) pandemic influenza vaccination was recommended as a priority to essential workers and high-risk individuals, including HIV-infected patients and people living in communities.

Methods

HIV-infected and HIV-uninfected former drug-users (18-60 years old) living in a rehabilitation community (San Patrignano, Italy) received one dose of a MF59-adjuvanted 2009 pandemic influenza vaccine and one dose of a 2009-2010 seasonal trivalent inactivated influenza vaccine (containing A/Brisbane/59/2007(H1N1), A/Brisbane/10/2007(H3N2), B/Brisbane/60/2008) simultaneously. Antibodies against each vaccine antigen were determined at the time of vaccination and one and six months post-vaccination by hemagglutination-inhibition test.

Results

49 HIV-infected and 60 HIV-uninfected subjects completed the study. Most (98%) HIV-infected participants were on antiretroviral treatment, the median CD4+ cell count was 350 (IQR 300) cells/μl and viremia was suppressed in 91.8% of cases. One month post-vaccination, no significant changes in immune-virological parameters were observed. One month post-vaccination, the immune responses to both pandemic and seasonal vaccine met the EMA-CPMP criteria for immunogenicity of influenza vaccines in both HIV-infected and HIV-uninfected subjects. No difference in vaccine responses was observed between the two groups. Six months after vaccination, the percentages of vaccinees with antibody titres ≥1:40 and antibody geometric mean titres significantly decreased in both groups. However, they were significantly lower in HIV-infected than in HIV-uninfected vaccinees. In subjects who had been primed to seasonal influenza the year before (through either vaccination or natural infection), levels of antibodies against 2009 A(H1N1) were higher than those measured in unprimed subjects, both one month and six months post-vaccination.

Conclusions

The co-administration of a single dose of 2009 pandemic MF59-adjuvanted influenza vaccine with a seasonal vaccine provided a protective immune response in both HIV-infected and HIV-uninfected individuals. Subjects who had been primed to seasonal influenza in the year preceding the pandemic had a more vigorous and long-lasting antibody response to 2009 pandemic vaccine.     

Understanding the potential and challenges of adenoma treatment as a prevention opportunity: insights from the BeWEL formative study

Objectives

To explore prevention opportunities presented by colorectal adenoma diagnosis and inform engagement strategies for the BeWEL study (body weight and physical activity lifestyle intervention for colorectal cancer screening participants who have undergone adenoma removal).

Methods

Qualitative study comprising 4 purposively sampled focus groups conducted in urban and rural areas in Tayside, Scotland, with different deprivation levels. Participants were men and women (n = 17) aged 50-74 with BMI > 25 kg/m² with removal of adenoma detected by colorectal cancer screening.

Results

Adenoma diagnosis presents both opportunities and challenges for prevention. Some patients perceived adenoma as minor and not sufficiently motivating to act as a ‘teachable moment’. Patients had low awareness of the relationship between adenoma and lifestyle factors, and received little information on prevention during screening and treatment. Consequently they interpreted post-treatment ‘all clear’ messages as validation of existing lifestyles, and did not see the relevance of prevention advice. Receptiveness increased when the association between lifestyle, adenoma recurrence and other illness was explained.

Conclusion

The study illustrates the value of exploratory research into patient understanding to improve communications and health services. Without unduly worrying patients, professionals should explain how to reduce risk of adenoma, cancer and other diseases, particularly through diet, physical activity and weight reduction.     

Acute disseminated encephalomyelitis following influenza vaccination

Introduction

Approximately 5% of cases of acute disseminated encephalomyelitis are preceded by vaccination within 1 month prior to symptom onset. This occurs rarely following influenza immunization.

Methods

Case presentation and literature review.

Results

A 75-year-old woman developed acute disseminated encephalomyelitis within 3 weeks of receiving the seasonal influenza vaccine. The patient subsequently passed away, despite treatment with methylprednisolone and plasma exchange therapy.

Conclusions

The literature on post-influenza vaccination encephalomyelitis is limited. The majority of published cases had favourable outcomes following treatment with intravenous methylprednisolone. Given the limited number of cases, no incidence estimates have been published.     

Birth order and private voluntary immunization--a study of 110,902 children

Background

Introduction of new private, voluntary immunizations often results in low vaccine uptake among certain sub-groups within the population. Revealing factors associated with underimmunization is crucial in vaccine endorsement and distribution.

Objective

Our goal was to investigate the effect of child's birth order on private voluntary varicella vaccination.

Methods

A nested case-control study was conducted on a cohort of 110,902 Israeli children under the age of 5 years. We compared social and demographic factors of immunized and unimmunized participants. Logistic regression models were built to examine the association between birth order and vaccination, controlling for child's age, gender, country of birth, ethnicity, parents’ country of birth, area of residence, and socioeconomic status (SES).

Results

Ethnicity had the highest association with varicella immunization status. The odds of vaccination in the general Jewish and Ultra-Orthodox Jewish populations were 25.55- (95%CI:20.13;32.42) and 15.04- (95%CI:10.18;22.22) times the odds in Arab population, respectively. Child's birth order was inversely related to vaccination status and presented a nonlinear exposure-response relationship. This relationship was maintained in different ethnicity and SES groups. Child's birth order was associated with vaccination differently in large (>3 siblings) and small to average-sized sibships (≤3 siblings). Other parameters associated with vaccination were child's and parents’ country of origin, area of residence and SES.

Conclusions

Birth order is an independent risk factor for underimmunization, associated with child's vaccination status beyond economic, social, and demographic parental characteristics.     

Safety of MF-59 adjuvanted vaccine for pandemic influenza: results of the vaccination campaign in an Italian health district

Background

The occurrence of pandemic H1N1 influenza in 2009 led health authorities to promptly start massive vaccination campaigns. Due to the need of shortening time for development and approval, the pandemic vaccine was prepared by mock-up strategy, and limited safety data were available upon starting vaccine administration.

Aims

To determine the frequencies and clinical features of adverse events (AEs) observed in a population of subjects of an Italian health district receiving pandemic vaccination. The risk for the development of at least one AE was calculated for patients receiving H1N1 vaccine only or H1N1 + seasonal vaccine.

Methods

This prospective observational study was performed on the population of La Spezia Health District scheduled to receive pandemic MF-59-adjuvanted H1N1 vaccine. Subjects were enrolled at the time of vaccine administration and followed up at least for 6 months. The study population was stratified in two subgroups defined by administration of H1N1 vaccine only or H1N1 + seasonal vaccine. AEs were recorded during the first hour following vaccine administration (early AEs) and through periodic telephonic interviews (delayed AEs).

Results

An overall number of 506 subjects receiving pandemic vaccine were enrolled (H1N1 only: 131 subjects; H1N1 + seasonal: 375 subjects). 233 AEs occurred throughout the study period. Among them, 211 were resolved, while 22 were ongoing at the last available follow-up. Adjusted incidence rate ratio (IRR) for the development of at least one AE was 1.14 (0.77-1.69) for H1N1 only group vs H1N1 + seasonal group. Patients with a nervous system AE were more frequent in the H1N1 + seasonal group (adjusted IRR: 2.33; 95%CI: 1.04-5.23). Only two cases of ischemic stroke, both in the H1N1 + seasonal vaccine group, occurred in patients with cardiovascular risk factors, were classified as serious AEs.

Conclusions

In the present study, the MF59-adjuvanted H1N1 vaccine was generally well tolerated. AEs were usually transient and mild to moderate in intensity. Our findings support the validity of mock-up strategy for rapid development of a safe vaccine in the emergency of a pandemic influenza.     

Where the wicked problems are: the case of mental health

Objective

To use system ideas and the concept of ‘wicked problems’ to frame examination of a decade-and-a-half of UK mental health policy.

Methods

Theoretically informed policy analysis.

Results

Modern health care is complex, and mental health care particularly so. In the UK the mental health system has also become a policymaking priority. Features of this system mean that many of the problems policymakers face are of the ‘wicked’ variety. Wicked problems are resistant. Problem formulations and their solutions are contestable. Solutions which have ‘worked’ in one setting may not ‘work’ in another, and evidence to guide change is open to challenge. Actions trigger waves with widespread system consequences. In the case of the UK's mental health field significant shifts have taken place in formulations of ‘the problem’ to which actions have been directed. These have included assessments of community care failure, formulations emphasising problems with the professions and, most recently, the need for action to promote mental health and wellbeing.

Conclusions

In their efforts to secure improvement in a neglected field UK policymakers have unleashed a torrent of top-down actions. Attention needs to be paid to constructing strong, system-wide, partnerships and to examining the cumulative impact of policy actions.