Baseline hepatitis B vaccination coverage among persons with diabetes before implementing a U.S. recommendation for vaccination

Background

Recent data suggest that adults with diabetes are at increased risk of incident hepatitis B infection and may suffer increased morbidity or mortality from chronic hepatitis B infection. In October 2011, the Advisory Committee on Immunization Practices (ACIP) recommended hepatitis B vaccination (HepB) for persons with diabetes aged 19–59 years and stated that persons with diabetes aged 60 years and older should be considered for vaccination.

Objective

To determine HepB coverage among persons with diabetes aged ≥19 years prior to implementation of the new ACIP recommendation and to determine predictors for vaccination.

Methods

We used the 2009 National Health Interview Survey to determine weighted proportions of self-reported HepB coverage (≥1 and ≥3 doses) among persons with diabetes aged ≥19 years. A multivariable logistic regression analysis was performed to determine factors independently associated with vaccination.

Results

Overall, 19.5% (95% CI: 17.4–21.6%) and 16.6% (14.7–18.6%) of persons with diabetes, aged ≥19 years, reported receiving ≥1 and ≥3 doses of HepB, respectively, compared with 30.3% (29.4–31.3%) and 26.5% (25.5–27.4%) among persons without diabetes. While unadjusted HepB coverage was higher among persons without diabetes, diabetes status was not associated with ≥1 or ≥3 dose vaccination. Among persons with diabetes, being a healthcare provider (OR 4.2, 2.5–7.0), ever tested for HIV (OR 2.6, 1.8–3.6), high-risk behaviors (OR 1.8, 1.0–3.4, P-value = 0.053) and having some college education (OR 1.7, 1.2–2.4) were all independently associated with vaccination.

Conclusion

HepB coverage among persons with diabetes is low. These data can be used to provide a baseline for measuring future progress toward vaccination of persons with diabetes.     

Intent to receive HPV vaccine and reasons for not vaccinating among unvaccinated adolescent and young women: findings from the 2006-2008 National Survey of Family Growth

Background and purpose

HPV vaccine coverage for females has increased in the U.S., although challenges to achieving high coverage remain. HPV vaccine coverage continues to lag behind that of other routinely recommended adolescent vaccines and these gaps in coverage are widening. To inform strategies to improve uptake, we explore correlates of vaccine intention and describe reasons for refusing HPV vaccination among unvaccinated females in a nationally representative sample of adolescents and young adults during early stages of HPV vaccine availability.

Methods

In 2007–2008, 1243 females aged 15–24 years were asked about HPV vaccination in the National Survey of Family Growth (NSFG). For unvaccinated women (n = 955), we evaluated demographic and sexual behavior correlates of likelihood to receive the vaccine in the next 12 months in bivariate and multivariable analyses by age. Correlates to the main reasons for foregoing vaccination are described.

Results

A minority (42.5%) of unvaccinated respondents said they intended to receive HPV vaccine in the next 12 months: 37.6% of adolescents (15–19 years) and 42.0% of young adults (20–24 years). Sexually experienced women were more than twice as likely as non-sexually experienced women to intend to receive HPV vaccine (15–19 years: aOR = 2.39, 95% CI = 1.15, 4.94; 20–24 years: aOR = 2.17, 95% CI = 1.08, 4.33). Having health insurance was associated with being likely to receive HPV vaccine among adolescents. Hispanic young adults were more likely than non-Hispanic Whites to be likely to receive HPV vaccine. The belief of not being at risk for HPV and institutional barriers were the two most commonly cited reasons for foregoing vaccination.Among unvaccinated women who did not intend to get vaccinated, respondents who never had sex were more likely to report not being at risk as the main reason for not needing the vaccine compared to women with sexual experience (44.5 vs. 24.4%) but this finding was only marginally significant in our limited sample.

Conclusion

In the first years immediately post-licensure of an HPV vaccine, the majority of unvaccinated women indicated that they were unlikely to seek vaccination. Intent to receive the HPV vaccine is tied to sexual experience and most women who do not intend to get vaccinated and have never had sex believe they are not at risk of HPV or do not need an HPV vaccine. These findings highlight the need to better communicate information regarding lifetime risk for HPV and the importance of receiving HPV vaccine prior to sexual initiation. These findings should inform strategies to increase vaccine uptake.     

Safety and immunogenicity of different two-dose regimens of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in healthy young adults

Background

Previous studies have shown that two doses of an investigational hepatitis B vaccine consisting of hepatitis B surface antigen combined with an immunostimulatory phosphorothioate oligodeoxyribonucleotide adjuvant (HBV-ISS) given 8 weeks apart provides seroprotection sooner than 3 doses of a licensed hepatitis B vaccine over 24 weeks. A more rapid schedule with a 4-week interval could provide earlier protection and potentially greater compliance.

Methods

In this randomized, double-blind study, healthy adults received two doses of HBV-ISS at 0 and 4 or 0 and 8 weeks; saline placebo was given at week 8 for the 0–4 schedule and at week 4 for the 0–8 schedule). Adverse events were collected after each dose. Antibodies were measured at 0, 4, 8, 12, and 32 weeks.

Results

Participants were randomized to the 0–4 (n = 18) or 0–8 (n = 23) weeks schedule. Rates of adverse events were similar in the two groups after the HBV-ISS injections regardless of the schedule, but more frequent than after the placebo injections. By 4 weeks post-dose-2, 94.1% of 0–4 and 100% of 0–8 recipients had protective antibody levels; geometric mean concentrations were 244 mIU/mL and 3217 mIU/mL respectively. By 32 weeks, the difference in antibody concentration had decreased (GMC 439 mIU/mL vs. 863 mIU/mL, respectively; p = 0.04).

Conclusions

A 0–4 weeks, two-dose regimen of HBV-ISS was well-tolerated and induced an antibody response that was similar to a 0–8 weeks schedule.     

Influenza vaccination uptake amongst pregnant women and maternal care providers is suboptimal

Objective

To assess the uptake of influenza vaccination by pregnant women and maternity care providers and explore their attitudes towards influenza vaccination.

Design, setting and participants

Cross-sectional survey administered in a Victorian tertiary level public hospital to 337 pregnant women and 96 maternity care providers.

Results

31.3% of patients planned to or had received influenza vaccination this year, but only a quarter had received education about influenza. Women were more likely to receive influenza vaccination if they had been vaccinated in the last two years (RR 4.5, 95% CI: 3.1–6.4, p < 0.001), received education about influenza (RR 2.3, 95% CI: 1.6–3.2, p < 0.001) or believed that they were at high risk of influenza-related complications while pregnant (RR 2.0, 95% CI: 1.4–2.7, p < 0.001). While only 56.8% of maternity care providers believed pregnant women were at high risk of influenza-related complications, 72.9% would recommend influenza vaccination to all pregnant women. Of the maternity care providers studied, 69% planned to or had been vaccinated in 2011, with this group more likely to recommend vaccination to their patients (RR 2.0, 95% CI: 1.3–3.0, p < 0.001). Significantly more maternity care providers indicated that they would routinely recommend influenza vaccination than the proportion of patients who reported receiving education.

Conclusions

Influenza vaccination rates in pregnant women are low, reflecting inadequate patient education despite most maternity care providers indicating that they would routinely recommend influenza vaccination. Increasing influenza vaccination uptake by women in pregnancy will require better education of both women and maternity care providers.     

Immunity to hepatitis A when outbreaks of infection in men who have sex with men (MSM) are rare

Background

Epidemics of hepatitis A among men who have sex with men (MSM) have decreased significantly in recent years although the level of immunity that is required to prevent epidemics has not been studied. Our aim was to determine the level of immunity to hepatitis A among MSM.

Methods

This was a retrospective study conducted using notifications of Hepatitis A in Victoria from 1991 to 2010, serological testing for hepatitis A among MSM attending Melbourne Sexual Health Centre (MSHC), and vaccination records among MSM attending MSHC.

Results

Hepatitis A notifications declined from 370 to 47 and the male to female ratio declined from 4.2 to 0.9 in Victoria between1991 to 2010. Between 2002 and 2011, there were 12,064 individuals MSM seen at MSHC of whom 3055 (25%) were tested for hepatitis A antibodies and 1180 (39%) had antibodies. The proportion of MSM who were tested for hepatitis A rose significantly over time (P < 0.01), but the proportion of these with hepatitis A antibodies did not (P = 0.28). Hepatitis A antibodies were more common in MSM over 30 (54%) compared to those 30 or less (32%), (Crude Odds Ratio 2.5 (95% confidence interval 2.1–2.9)) and were uncommon in MSM under 20 (19%). Vaccination against hepatitis A was recorded in 49% of 660 clinical files of MSM who attended the centre between 2003 and 2011 and did not change over time (P = 0.42) but was significantly more common in those over 30 years of age (P < 0.005).

Conclusion

Hepatitis A is rare in MSM in Victoria where levels of immunity are about 40–50%. As outbreaks have occurred when levels of immunity were around 30%, maintaining vaccination levels over 40–50% is important if outbreaks are to be prevented. The lower levels of immunity in younger MSM create the potential for outbreaks in this sub-group.     

Effect of needle length for response to hepatitis B vaccine in macrosomic neonates: a prospective randomized study

Objectives

The objective of this study was to determine whether use of a longer (1 in.) rather than a standard (5/8 in.) needle used for macrosomic neonates (birthweight over 4000 g) may affect antibody titers after immunization against hepatitis B virus (HBV).

Methods

Fifty nine healthy infants were vaccinated at birth, 1, and 6 months of age with hepatitis B vaccine, with follow up to 7 months of age. Infants were randomized into two groups according to needle length of first vaccine at birth. First group vaccinated with standart needle length and other group received vaccine by longer needle length.

Results

Macrosomic infants who were immunized with a longer needle achieved significantly higher antibody titers to hepatitis B surface antigen than standart needle length (median, 3890.2 vs 1311.7 mIU/mL, respectively; p = 0.001).

Conclusions

Macrosomic neonates benefit from longer needle length with higher levels of antibody titers after HBV vaccination.     

Hepatitis B virus carrier rate, prevalence and susceptibility and impact of immunization program among households in the city of Taiz, Yemen

Objective

To examine the carrier rate, prevalence and susceptibility to hepatitis B virus infection in the city of Taiz, Yemen.

Methods

In a community-based household survey 521 subjects from 98 randomly selected households were enrolled. Carrier rate, prevalence and susceptibility of hepatitis B virus infection in the city of Taiz, Yemen were examined.

Results

The median age of the subjects was 19 years (range <1–85 years), 219 (42.0%) of whom were males and 305 (58.0%) were females. The HBsAg carrier rate was 4.2% (22/521), the prevalence was 16.9% (88/521) and the susceptibility rate was 57.5% (287/499). Male vs female carrier rate, prevalence and susceptibility rate were comparable. Children (age ≤18 years) vs adults had carrier rates of 2.7% vs 5.7% (odds ratio = 2.2) and a prevalence of 5.1% vs 28.4% (OR: 5.6). The carrier rate, prevalence and immunity to HBV among subjects who reported vaccination vs those unvaccinated was; 2.1% vs 5.5%, 11.3 vs 20.8% and 53.1% vs 18.8%. A proportion of 47.2% of subjects who aged ≤10 years had isolated anti-HBs. Of 142 of the cohort born after full implementation of vaccination program (age:≤9 years) 72 (50.7%) were immune and 70 (49.3%) were susceptible whereas of 357 subjects borne before program implementation (Age:≥10 years) 140 (39.2%) were immune and 217 (60.8%) were susceptible (p < 0.02 (Pearson) OR: 1.6 CI = 0.42–0.93).

Conclusions

An intermediate endimicity was identified in Taiz city. Vaccination reduced carrier rate prevalence and susceptibility among vaccinated subjects. The high rate of subjects with isolated anti- HBs together with the reduced susceptibility rate among the cohort born after inclusion of HBV vaccine to EPI reflects impact of the program. Improving vaccination coverage will further reduce susceptibility rate.     

Progressive changes in pneumococcal carriage in children attending daycare in Portugal after 6 years of gradual conjugate vaccine introduction show falls in most residual vaccine serotypes but no net replacement or trends in diversity

Objectives

To track ongoing trends in pneumococcal (Sp) serotype carriage under the selection pressure of moderate pneumococcal conjugate vaccine (PCV) use, children in a community in Portugal were studied in the same months in 3 consecutive years.

Methods

Nasopharyngeal specimens were collected (children aged 3 months to <7 years) in 8 urban daycare centers in February 2008 (n = 561) and 2009 (n = 585). Sp isolates were serotyped.

Results

While demographics were similar in 2008–2009 and a previously reported sample in 2007, PCV coverage (at least one dose) in the children studied rose from 76.5% to 84% although national coverage was lower than this. Sp carriage fell from 61% to 51% with a concomitant fall in PCV7 serotype carriage from 12.1% to 4.3%. Remaining PCV7 serotypes declined to near (23F) or totally (6B, 14) undetectable levels except 19F which persisted unchanged in around 4% of children. Although carriage of 3 and 6C rose, there was no net increase in non-PCV7 serotypes and no progressive trend in serotype diversity.

Conclusions

Ecological changes induced by PCVs where uptake is moderate appear to be different from high usage settings. We report falling Sp carriage due to PCV7 serotype disappearance with persistence of 19F and no ongoing net replacement after several years of PCV7 use and slowly rising uptake.     

Streptococcus pneumoniae serotypes isolated from the middle ear fluid of Costa Rican children following introduction of the heptavalent pneumococcal conjugate vaccine into a limited population

Background

The heptavalent pneumococcal conjugate vaccine (PCV-7) was introduced in high risk children and into the private market in Costa Rica in 2004 (<5% annual birth cohort). The aim of this study was to compare the Streptococcus pneumoniae serotype (ST) distribution, antibiotic resistance patterns and potential coverage before and after partial introduction of PCV-7.

Methods

A comparison between the S. pneumoniae isolates obtained and serotyped from the middle ear fluid (MEF) of Costa Rican children with otitis media between years 1999 and 2003 (before PCV-7 usage) and those isolates obtained from 2004 to 2008.

Results

A total of 145 and 218 MEF S. pneumoniae were serotyped between years 1999 and 2003 and 2004 and 2008, respectively. Considering a 19F outbreak observed between years 1999 and 2003, the following statistically significant changes in serotype distribution were detected between1999 and 2003 and 2004 and 2008: ST 3: 4.8–12.8% (P = 0.01); ST 11A: 0–4.1% (P = 0.01); ST 14: 3.5–21.1% (P < 0.001) and ST 19F: 52.4–18.3% (P < 0.05). Comparison of the two study periods demonstrated that during 2004 and 2008 a statistically significant decrease in penicillin non-susceptible serotypes (36.2–20.4% [P = 0.003]) and a statistically significant increase in trimethoprim-sulfametoxazole resistant serotypes (54.9–68.5%, respectively [P = 0.03]) was observed. Potential pneumococcal vaccines coverage between 1999 and 2003 and between 2004 and 2008 were: for PCV-7: 77.2–60.5%, respectively (P = 0.001); for the 10-valent conjugated vaccine (PCV-10): 78.6–61.4%, respectively (P = 0.0008) and for the 13-valent conjugated vaccine (PCV-13): 84.8–79.3%, respectively (P = 0.2).

Conclusions

Changes in the serotype distribution and antimicrobial susceptibility of MEF S. pneumoniae have been observed in Costa Rican children with OM. Because of the limited use of PCV-7 during the study period, these changes probably cannot be attributed to PCV-7 use. Between 2004 and 2008, PCV-13 offered the highest potential vaccine coverage.     

Sustained viral load reduction in treatment-naive HCV genotype 1 infected patients after therapeutic peptide vaccination

Background

Novel antivirals augment treatment efficacy in chronic HCV infection, to overcome limitations on safety profile alternative approaches are warranted. The effect of a therapeutic peptide vaccine on HCV viral load was investigated in treatment-naïve genotype 1 HCV patients.

Methods

Fifty patients received 8 intradermal IC41 vaccinations biweekly with topical application of the TLR7 agonist imiquimod (Group A). In Group B, 21 patients received a condensed schedule of 16 subcutaneous vaccinations weekly without imiquimod.

Results

At Week 16 Group A (n = 44) showed a statistically significant (p = 0.0013) HCV viral load decline of 0.21 log. 24 weeks after the last vaccination the viral load decreased by 0.47 log (p < 0.0001) in 34 subjects. This effect was more pronounced in 17 patients with high baseline HCV (>2 × 10⁶ IU/ml) with a 0.61 log decline, which was statistically significant (p < 0.02) starting two weeks after the third vaccination. No apparent effect on HCV viral load was observed in Group B (n = 21). In Group A eight patients (24%) showed a viral load response defined as a decline of >0.8 log. Overall, about 30–55% of patients showed T cell responses during the vaccination series and up to six months in both groups. No significant correlations between the HCV viral load decrease and T cell immune response were detected.

Conclusions

This is the first report on a significant antiviral effect of a peptide vaccine in HCV infected patients. Response kinetics with increased HCV RNA decline 24 weeks after the last IC41 vaccination is encouraging.     

Safety of live, attenuated oral vaccines in HIV-infected Zambian adults: Oral vaccines in HIV

Background

Current recommendations are that HIV-infected persons should not be given live vaccines. We set out to assess potential toxicity of three live, attenuated oral vaccines (against rotavirus, typhoid and ETEC) in a phase 1 study.

Methods

Two commercially available oral vaccines against rotavirus (Rotarix) and typhoid (Vivotif) and one candidate vaccine against Enterotoxigenic Escherichia coli (ACAM2017) were given to HIV seropositive (n = 42) and HIV seronegative (n = 59) adults. Gastrointestinal symptoms were sought actively by weekly interview up to 1 month of vaccination. In rotavirus vaccine recipients, intestinal biopsies were collected by endoscopy and evaluated for expression of IL-8 and pro-inflammatory cytokines.

Results

No difference was observed between symptoms in HIV infected and HIV uninfected vaccinees, except for diarrhoea reported more than 7 days after the last dose of vaccine. If only diarrhoea episodes within 7 days of vaccination are included, diarrhoea was not more frequent in HIV seropositive than in HIV seronegative vaccinees (OR 6.7, 95% CI 1.2–67; P = 0.09). However, if later episodes of diarrhoea are included, a significant increase in diarrhoea was demonstrated (OR 5.3, 95% CI 0.98–53; P = 0.04). All episodes were mild and transient. IL-8 was slowly up-regulated over the week following vaccination (P = 0.02), but IL-β, IFNγ or TNFα were not.

Conclusions

No evidence was found of adverse events following administration of these three vaccines, except for late episodes of diarrhoea which may not be attributable to vaccination. Our data do not support the need for a prohibition on oral administration of live, attenuated vaccines to all HIV infected adults, though further work on severely immunocompromised adults and children are required.     

Using data to guide policy: Next steps for preventing perinatal hepatitis B virus transmission in Cambodia

Background

Cambodia is highly endemic for hepatitis B virus (HBV) infection. Preventing perinatal HBV transmission should be prioritized in health facilities by providing hepatitis B vaccination to all infants within 24 h of birth (timely birth dose coverage).

Methods

Teams assessed birth dose policy, practices and coverage in hospitals and health facilities in 10 provinces in Cambodia.

Results

Fifty-one sites were assessed. Median (interquartile range) timely birth dose coverage was 66% (48–92%); coverage was 88% (range = 60–96%) in facilities vaccinating on-site and 48% (range = 20–52%) in those referring off-site (p < 0.0001). Overall, 5 (29%) of 16 hospitals that referred vaccination off-site did not tell mothers vaccination should take place within 24 h of birth, and 6 (35%) discharged mothers when no vaccination services were available for infants to receive the birth dose.

Conclusions

Newborns can miss a time-sensitive opportunity to be protected against perinatal HBV infection when they are referred for vaccination off-site rather than being vaccinated in the delivery facility. These data support the case to strengthen policies and practices to provide hepatitis B birth dose vaccination in the delivery facility.     

Regulatory T cells are the most important determinant factor of hepatitis B infection prognosis: A systematic review and meta-analysis

Introduction

Association of increased levels of CD4⁺CD25⁺ regulatory T cells (Tregs) with impaired immune response and hepatitis B infection progression has been proposed. For determination of Tregs various effects among hepatitis B infected patients we performed a meta-analysis of the available literature.

Methods

Current content, abstract books of congresses, and electronic databases were searched. Critical appraisal has been done. According to the result of heterogeneity tests (Q, I-squared, and Tau-squared), we used fix/random model for analysis.

Result

Twelve studies that fulfilled inclusion criteria entered to analysis. Pooled estimation of reported results showed that CD4⁺CD25⁺ Tregs have higher expression of forkhead box P3 (FoxP3) versus CD4⁺CD25⁻ Tregs, odd ratio (OR) was 31.49 (95% Confidence Intervals (CI): 5.09–194.94). Tregs level among chronic hepatitis B (CHB) patients was 77% (OR = 1.77 95% CI: 1.43–2.19) higher than healthy controls. Patients with more than 10,000,000 HBV copies/ml have higher level of Tregs (OR: 1.24 95% CI: 1.08–1.41) comparing subjects with less than that. CHB patients have increased level of Tregs versus acute hepatitis B patients (OR = 1.33 95% CI: 1.16–1.52). CD8 cells activity increased significantly after depletion of circulating Tregs (OR = 1.93 CI: 1.37–2.73). Also, Tregs reduce response to treatment and non-responders to INF-α had higher level of Tregs (OR = 1.60 95% CI: 1.09–2.36). In addition, Tregs increase risk of hepatocellular carcinoma (HCC) (OR = 1.36 95%CI: 1.10–1.69).

Conclusion

Tregs influence HBV infected patients in various states. Tregs determine the disease prognosis by leading to infection progression and impairing immune response. So, Tregs are therapeutic target for immunotherapy of HBV infection.     

Significance and anamnestic response in isolated hepatitis B core antibody-positive individuals 18 years after neonatal hepatitis B virus vaccination in Taiwan

Aim

To investigate the significance of isolated hepatitis B core antibody (anti-HBc) and to analyze the response to hepatitis B virus (HBV) booster vaccination in young adults with isolated anti-HBc who had been fully vaccinated with HBV vaccine as infants.

Materials and methods

We screened 1734 new university entrants who had been fully vaccinated against HBV in infancy for the presence of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), and anti-HBc upon university entry. Results positive for isolated anti-HBc were reconfirmed by testing for the presence of HBsAg and anti-HBc once more, and further evaluated for anti-HCV, anti-HIV, and HBV DNA status 6 months later. Students were also offered HBV booster vaccinations at that time. Geometric mean titers (GMT) of anti-HBs after one booster dose of HBV were compared between students with isolated anti-HBc and students with HBV naïve status.

Results

The overall prevalence of isolated anti-HBc in our student cohort was 1.2% (21 of 1734). No evidence of occult HBV infection was observed. A “booster” anamnestic response (anti-HBs titer ≥10 mIU/mL) was noted in 95% (20 of 21) of subjects with isolated anti-HBc. After re-measurement of anti-HBc, 13 (62%) of the 21 subjects with isolated anti-HBc were reclassified as having resolved HBV infection with a loss of anti-HBs. In the remaining 8 subjects (38%), isolated anti-HBc was determined to be false positive. The HBV status of these 8 subjects was HBV naïve due to the waning-off effect of anti-HBs of the neonatal HBV vaccination. There was no significant difference in anamnestic response to a single HBV booster dose of vaccine between students with isolated anti-HBc (n = 13) and those with HBV naïve (n = 323) status (GMT 50.6 vs 47.7 mIU/mL, P = 0.90).

Conclusion

The presence of isolated anti-HBc 18 years after HBV vaccination can be attributed to post-HBV infection with a loss of anti-HBs and to a decline in anti-HBs elicited by vaccine. A single HBV booster dose of vaccine is recommended for subjects with isolated anti-HBc who were fully vaccinated with HBV vaccine as infants. This finding needs to be replicated in further studies with larger cohorts.     

Risk factors for low vaccination coverage among Roma children in disadvantaged settlements in Belgrade, Serbia

Background

Full vaccination coverage for children under 59 months of age in Serbia is over 90%. This study assesses vaccination coverage and examines its association with birth registration among Roma children who resided in disadvantaged settlements in Belgrade, Serbia.

Methods

The First Roma Health and Nutrition Survey in Belgrade settlements, 2009, was conducted among households of 468 Roma children between the ages of 6–59 months. The 2005 WHO Immunization Coverage Cluster Survey sampling methodology was employed. Vaccinations were recorded using children's vaccination cards and through verification steps carried out in the Primary Health Care Centers. For those who had health records the information on vaccination was recorded.

Results

About 88% of children had vaccination cards. The mean rate of age appropriate full immunization was 16% for OPV and DTP and 14.3% for MMR. Multivariate analyses indicated that children whose births were registered with the civil authorities were more likely to have their vaccination cards [OR = 6.1, CI (2.5, 15.0)] and to have their full, age appropriate, series vaccinations for DTP, OPV, MMR and HepB [OR = 3.8, CI (1.5, 10.0), OR = 3.2, CI (1.5, 6.6), OR = 4.8, CI (1.1, 21.0), OR = 5.4, CI (1.4, 21.6), respectively].

Conclusions

The immunization coverage among Roma children in settlements is far below the WHO/UNICEF MDG4 target in achieving prevention and control of vaccine preventable diseases. It demonstrates the need to include “invisible” populations into the health systems in continuous, integrated, comprehensive, accessible and sensitive modes.     

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates

Background

A manufacturing process using a modified adjuvant was developed to optimize the consistency and immunogenicity for recombinant hepatitis B vaccine (control: RECOMBIVAX-HB™). This modified process hepatitis B vaccine (mpHBV), which was previously shown to have an acceptable safety and immunogenicity profile in young adults, has now been studied in newborn infants.

Methods

Healthy 1–10-day-old neonates (N = 566) received 3 intramuscular doses (5 μg hepatitis B surface antigen [HBsAg] per dose) of either mpHBV or control at Day 1, and Months 1 and 6. Serum antibody to HBsAg (anti-HBs) was assayed at Month 7 (1 month Postdose 3). Anti-HBs geometric mean titers (GMTs) and seroprotection rates (SPRs) (% of subjects with an anti-HBs titer ≥10 mIU/mL) were compared at Month 7. After each dose, injection-site adverse experiences (AEs) and axillary temperatures were recorded for 5 days; systemic AEs were recorded for Days 1–14.

Results

Month 7 SPR was 97.9% for the mpHBV group and 98.9% for the control. The GMT was 843.7 mIU/mL for the mpHBV group and 670.1 mIU/mL for the control. The GMT ratio (mpHBV/control) was 1.26 (95% confidence interval [CI]: 0.94, 1.69), meeting the prespecified non-inferiority criteria. The percentages of subjects reporting any AE, injection-site AEs, or systemic AEs were similar across the 2 vaccination groups. There were no serious AEs.

Conclusions

The safety profile of mpHBV was comparable to that of the control vaccine. The geometric mean antibody titer for mpHBV was higher than control vaccine in this infant population, but the difference did not meet the predefined statistical criterion for superiority.     

Prevention of perinatal hepatitis B virus transmission in the Netherlands, 2003-2007: children of Chinese mothers are at increased risk of breakthrough infection

Background

In the Netherlands, different hepatitis B vaccination schedules have been used for children born to HBV-infected mothers. All schedules included a birth dose of hepatitis B immunoglobuline (HBIg). We assessed determinants of perinatal HBV transmission and determinants of anti-HBs titers in infants born to HBsAg positive mothers.

Methods

We included infants born to HBV infected mothers between 1.1.2003 and 30.6.2007, using national databases and a separate database for Amsterdam. Risk factors for perinatal transmission and determinants of the anti-HBs titer were studied using logistic and linear regression, respectively.

Results

Of 2657 infants registered in the national database, 91% were registered to have received HBIg and at least three hepatitis B vaccinations. In Amsterdam, this coverage among 413 children at risk was higher (96%, p < 0.01). Serological test results for 2121 infants (80%) indicated that 13 (0.6%) were HBsAg positive. A mother of Chinese descent was the only risk factor for perinatal HBV infection identified (RR 9.1, 95% CI 3.1–26.8). Receiving a birth dose of hepatitis B vaccine later than in the first week of life was not associated with an increased risk of perinatal HBV infection. A shorter period between last vaccination and testing, and having received more doses of hepatitis B vaccine were independently associated with a higher anti-HBs titer.

Conclusions

Infants born to Chinese mothers were at increased risk of perinatal HBV infection. All HBsAg positive pregnant women of Chinese origin should be assessed to determine whether there is an indication for anti-viral treatment during pregnancy. Among infants who received HBIg at birth, we did not detect an increased risk of perinatal HBV infection when the first dose of hepatitis B vaccine was administered after the first week of life.     

Clinical effectiveness of pneumococcal polysaccharide vaccine in men: California Men's Health Study

Objective

To examine the effectiveness of pneumococcal polysaccharide vaccine (PPV) among approximately 40,000 community-dwelling men aged 45 years and older in the California Men's Health Study (CMHS) cohort.

Methods

All participants completed an extensive questionnaire at baseline (2002–2003) and were followed for the occurrence of invasive pneumococcal disease (IPD) or all-cause pneumonia hospitalization through the end of 2009. Immunization status and incident IPD and pneumonia cases were ascertained through electronic medical records. The associations between vaccination and IPD or pneumonia hospitalization were assessed using time-dependent Cox proportional models to account for sociodemographics, time-updated vaccination status, and comorbidities.

Results

The median follow-up period of the 39,222 participants was 7.3 years. Among them, 11,902 (30.3%) had received at least one PPV vaccine at baseline and 7653 (19.5%) received their first PPV vaccine during the follow-up. There were 17 pneumococcal bacteremia cases, 647 hospitalized pneumonia cases, and no pneumococcal meningitis cases. The results suggested a reduced risk of pneumococcal bacteremia among men vaccinated at age ≥65 (adjusted hazard ratio [HR]: 0.35; 95% confidence interval [CI]: 0.06–1.91; p = 0.22). PPV vaccination did not show a protective effect against all-cause pneumonia hospitalization (adjusted HR: 1.18; 95% CI: 1.02–1.37, p = 0.03) among men vaccinated before 65 years old, but a moderate protective effect was suggested among men without chronic obstructive pulmonary diseases who were vaccinated after 65 years old (adjusted HR: 0.84; 95% CI: 0.67–1.06, p = 0.15).

Conclusions

The findings in this large cohort of men in Southern California suggested a benefit of PPV for protection against pneumococcal bacteremia among men vaccinated at age 65 years and older. PPV might not provide adequate protection against all-cause pneumonia hospitalization among men.     

Human papillomavirus vaccination and sexual behaviour: cross-sectional and longitudinal surveys conducted in England

Objective

To examine whether HPV vaccination influences sexual behaviour in adolescent girls, either by giving them a ‘green light’ to have sex, or because perceived protection afforded by the vaccine permits compensatory risky sexual behaviour.

Design

Cross-sectional and longitudinal surveys.

Setting

Seven English schools.

Main outcome measures

Self-reported sexual behaviour.

Participants

The cross-sectional survey included 1053 girls (mean age 17.1 years) who had (n = 433 recruited in March 2010) or had not (n = 620 recruited in March 2009) been offered the HPV vaccine. The longitudinal survey included 407 girls (mean age 17.5 years) who had been offered HPV vaccination and had either received at least one dose (n = 148) or had not received any doses (n = 259).

Results

In the cross-sectional survey, the group of girls who had been offered the HPV vaccine were no more likely to be sexually active than the group of girls who had not been offered the HPV vaccine. In the longitudinal survey, the vaccinated group were no more likely to have changed their condom use or increased their total number of sexual partners than the unvaccinated group.

Conclusions

Neither being offered the HPV vaccine nor receiving it affected sexual behaviour.