Prevalence of measles antibodies among health care workers in Catalonia (Spain) in the elimination era.

BACKGROUND: Interruption of measles transmission was achieved in Catalonia (Spain) in 2000. Six years later, a measles outbreak occurred between August 2006 and June 2007 with 381 cases, 11 of whom were health care workers (HCW).The objective was to estimate susceptibility to measles in HCW and related demographic and occupational characteristics. METHODS: A measles seroprevalence study was carried out in 639 HCW from six public tertiary hospitals and five primary healthcare areas. Antibodies were tested using the Vircell Measles ELISA IgG Kit. Data were analyzed according to age, sex, type of HCW, type of centre and vaccination history.The odds ratios (OR) and their 95% CI were calculated to determine the variables associated with antibody prevalence. OR were adjusted using logistic regression.Positive predictive values (PPV) and the 95% confidence intervals (CI) of having two documented doses of a measles containing vaccine (MCV) for the presence of measles antibodies and of reporting a history of measles infection were calculated. RESULTS: The prevalence of measles antibodies in HCW was 98% (95% CI 96.6-98.9), and was lower in HCW born in 1981 or later, after the introduction of systematic paediatric vaccination (94.4%; 95% CI 86.4-98.5) and higher in HCW born between 1965 and 1980 (99.0%; 95% CI 97.0-99.8). Significant differences were found for HCW born in 1965-1980 with respect to those born in 1981 and after (adjusted OR of 5.67; 95% CI: 1.24-25.91).A total of 187 HCW reported being vaccinated: the proportion of vaccinated HCW decreased with age. Of HCW who reported being vaccinated, vaccination was confirmed by the vaccination card in 49%. Vaccination with 2 doses was documented in only 50 HCW, of whom 48 had measles antibodies. 311 HCW reported a history of measles.The PPV of having received two documented doses of MCV was 96% (95% CI 86.3-99.5) and the PPV of reporting a history of measles was 98.7% (95% CI 96.7-99.6). CONCLUSIONS: Screening to detect HCW who lack presumptive evidence of immunity and vaccination with two doses of vaccine should be reinforced, especially in young workers, to minimize the risk of contracting measles and infecting the susceptible patients they care for.

Educating on professional habits: attitudes of medical students towards diverse strategies for promoting influenza vaccination and factors associated with the intention to get vaccinated.

BACKGROUND: Influenza vaccination coverage in medical students is usually low. Unlike health care workers, there is little information on the attitudes to and predictors of vaccination among medical students, and their attitudes towards institutional strategies for improving rates are unknown. METHODS: This cross-sectional study evaluated the effect of three influenza vaccination promotional strategies (Web page, video and tri-fold brochure) on medical students' intention to get vaccinated and associated factors. A total of 538 medical students were asked to answer an anonymous questionnaire assessing the intention to get vaccinated after exposure to any of the promotional strategies. Sociodemographic data collected included: sex, age, university year, influenza risk group and cohabiting with member of a risk group. RESULTS: Four hundred twenty-one students answered the questionnaire, of whom 312 (74.1%) were female, 113 (26.8%) had done clinical rotations, and 111 (26.6%) reported intention to get the flu shot. Logistic regression showed the web group had a greater intention to get vaccinated than the reference group (OR: 2.42 95% CI: 1.16-5.03). Having done clinical rotations (OR: 2.55 95% CI: 1.36-4.38) and having received the shot in previous flu seasons (OR: 13.69 95% CI: 7.86-23.96) were independently associated with the intention to get vaccinated. CONCLUSION: Given that previous vaccination is a factor associated with the intention to get vaccinated, education on vaccination of health care workers should begin while they are students, thereby potentiating the habit. In addition, the intention to get vaccinated was greater during the clinical phase of the university career, suggesting this is a good time to introduce promotion strategies. Online promotional campaigns, such as a thematic Web to promote vaccination of health workers, could improve the intention to get vaccinated.

Influence of socioeconomic status on community-acquired pneumonia outcomes in elderly patients requiring hospitalization: a multicenter observational study.

BACKGROUND: The associations between socioeconomic status and community-acquired pneumonia outcomes in adults have been studied although studies did not always document a relationship.The aim of this multicenter observational study was to determine the association between socioeconomic status and community-acquired pneumonia outcomes in the elderly, in the context of a public health system providing universal free care to the whole population. METHODS: A total of 651 patients aged > or =65 years hospitalized due to community-acquired pneumonia through the emergency departments of five Spanish public hospitals were recruited and followed up between May 2005 and January 2007. The primary outcomes studied were: length of stay, intensive care unit admission, overall mortality and readmission. Socioeconomic status was measured using both individual and community data: occupation [categorized in six social groups (I, II, III, IVa, IVb and V)], educational level (< or = primary level or > or = secondary level) and disposable family income of the municipality or district of residence [>12,500 euro (high municipality family income) and < or =12,500 euro (low municipality family income)]. The six social groups were further categorized as upper/middle social class (groups I-IVb) and lower class (group V).Bivariate and multivariate analyses were performed. OR and their 95% confidence intervals were calculated. All statistical tests were two tailed and statistical significance was established as p < 0.05. RESULTS: 17.7% of patients lived in a municipality or district with a high municipality family income and 63.6% were upper/middle social class (I-IVb). Only 15.7% of patients had a secondary education. The adjusted analysis showed no association between pneumonia outcomes and social class, educational level or municipality family income. However, length of stay increased significantly in patients in whom the factors, living alone and being a smoker or ex-smoker coincided (p < 0.001). CONCLUSIONS: We measured socioeconomic status using both individual and community data and found no association between social class, educational level or municipality family income and the variables of pneumonia outcomes. The lack of differences between social classes supports the provision of universal, equitable health care by the public health system.

Cervical cancer vaccination indications, efficacy, and side effects.

Due to the limited contact of the human papillomavirus (HPV) with the immune system, past infection does not guarantee lasting protection. Two preventive vaccines (Gardasil and Cervarix) that can impede persistent HPV infection and its consequences are now available. They use structural L1 capsular proteins obtained by genetic recombination and antigens for genotypes 16 and 18, which are responsible for around 70% of cases of uterine cancer worldwide. Evaluation of their protective efficacy is based on the capacity of the vaccine to prevent persistent infection and cervical intraepithelial neoplasia (CIN). Phase I and II trials showed the safety of these vaccines and their capacity to produce very-high titers of antibodies (low or non-existent after natural infection). Phase II and III trials have confirmed these aspects and shown an efficacy of nearly 100% in the protocol analysis in preventing infection and the CIN associated with oncogenic vaccine genotypes. Some trials have also shown cross-protection against infections produced by other genotypes (such as 45 and 31). The optimal vaccination strategy is vaccination of girls aged 8-14 years. Other strategies should include the catch-up of adolescent and women not yet sexually-active, as well as the vaccination of sexually-active women. The progressive development of primary prevention strategies should coexist with secondary prevention with redesigned screening programs. The successful development of vaccination programs will require the support of public health authorities, the coordination of health workers from different areas and increased public awareness.

Spanish travelers to high-risk areas in the tropics: airport survey of travel health knowledge, attitudes, and practices in vaccination and malaria prevention.

OBJECTIVE: To evaluate travel health knowledge, attitudes, and practices on vaccination and malaria prevention among Spanish travelers to the tropics. METHODS: A cross-sectional survey was carried out in the departure lounge of the two main Spanish international airports in the summer of 2004. A questionnaire was administered to 1,206 Spanish citizens traveling to high-risk areas of tropical South America, 635 travelers (52.6%); Southeast Asia, 251 (20.8%); Sub-Saharan Africa, 181 (15.0%), and the Indian subcontinent, 139 (11.6%). Risk areas were defined according to published sources. Travelers were asked about their attitudes to travel vaccines and malaria prophylaxis and whether they had received either or both on this or previous trips. Adequate malaria prophylaxis was considered as the correct drugs for the destination as indicated by the World Health Organization. RESULTS: Fifty-eight percent of travelers were male and the mean age was 38 years. Thirty-six percent were traveling to tropical areas for the first time. The main reason for travel was tourism (82%) or business (12%). The mean time preparing the trip was 39 days; 73% looked for information a mean of 19 days in advance and 54% were advised in travelers' clinics. Fifty-five percent received no travel vaccines. A total of 48.1% of tourists and 30.1% of business travelers were vaccinated (p<0.00006). The most frequent vaccines administered were as follows: typhoid fever, 32%; yellow fever, 29%; tetanus-diphtheria, 24%; and hepatitis A, 14%. Malaria prophylaxis was taken by 422 travelers including mefloquine (44%), atovaquone-proguanil (17%), chloroquine (16%), chloroquine-proguanil (15%), doxycycline (3%), and unknown (5%). CONCLUSIONS: More than half of travelers to risk areas received no vaccinations before the trip. More than a third of travelers to Sub-Saharan Africa received no malaria prophylaxis.

Herpes zoster after yellow fever vaccination.

An immunocompetent 64-year-old women presented with brachial herpes zoster (HZ) infection 3 days after vaccination against yellow fever (YF). The lesions disappeared after antiviral treatment. There are very few reports of a possible association between YF vaccination and HZ infection. This case supports the importance of continuing surveillance of vaccine adverse events.

[Post-transplantation vaccination of bone-marrow transplant recipients]. / Vacunación de pacientes receptores de trasplante de progenitores hematopoyéticos.

BACKGROUND: Patients subject to bone marrow transplantation (BMT) and other blood stem cell transplantations are severely immunocompromised after transplantation. Some studies have suggested that post-transplantation loss of acquired immunity may play a role. The objective of this study was to determine the susceptibility to vaccine-preventable diseases in people subject to BMT and the serologic response after vaccination. PATIENTS AND METHOD: Study population was people subject to transplantation at least 6 months before initiating vaccination and without immunosuppressive treatment at that time. A prevaccination serologic analysis was carried out, and the hepatitis B, the adult tetanus-diphtheria (Td), the IPV, the influenza and the pneumococccal vaccines were administered in accordance with standard guidelines Depending on the immune status of the patient according to the serologic analysis, the MMR vaccine was administered no sooner than 18 months after transplantation. After vaccination, a serologic analysis was carried out to determine the response. RESULTS: The mean time SD between transplant and the initiation of vaccination was 3.2 2.9 years. Of the 122 recipients of BMT (average age 35.8 13 years; 54.2% male), 51.7% received an allogenic and 48.3% an autologous transplant. Before vaccination, the susceptibility was 48.2% for tetanus, 66.7% for diphtheria, 74.1% for pertussis, 85.9% for hepatitis B, 13.4% for measles, 36.7% for rubella and 9.2% for mumps. The rates of seroconversion with protective titers after vaccination for tetanus, diphtheria and hepatitis B were 94%, 67% and 75% respectively. The response to the MMR vaccine was greater than 70%, with a second dose of the vaccine being needed in 26% of patients. CONCLUSIONS: Susceptibility to vaccine-preventable diseases in transplanted patients is high. The acceptable response to vaccination justifies the development of specific programs. Given the special characteristics of this group of patients, vaccination programs must be simple and flexible.

Are healthcare workers immune to rubella?

Healthcare workers (HCW) have high exposure to infectious diseases, some of which, such as rubella, are vaccine-preventable. The aim of this study was to determine the immunity of HCW against rubella. We performed a seroprevalence study using a self-administered survey and obtained blood samples to determine rubella Immunoglobulin G (IgG) antibody levels in HCW during preventive examinations by five Primary Care Basic Prevention Units and six tertiary hospitals in Catalonia. Informed consent was obtained. IgG was determined using an antibody capture microparticle direct chemiluminometric technique. The odss ratio (OR) and 95% confidence intervals (CI) were calculated. Logistic regression was made to calculate adjusted OR. Of 642 HCW who participated (29.9% physician, 38.8% nurses, 13.3% other health workers and 18% non-health workers), 46.6% were primary care workers and 53.4% hospital workers. Of total, 97.2% had rubella antibodies. HCW aged 30-44 years had a higher prevalence of antibodies (98.4%) compared with HCW aged<30 years (adjusted OR 3.92; 95% CI 1.04-14.85). The prevalence was higher in nurses than in other HCW (adjusted OR: 5.57, 95% CI 1.21-25.59). Antibody prevalence did not differ between females and males (97.4% vs. 97.1%, P 0.89), type of center (97.7% vs. 96.8%, P 0.51) or according to history of vaccination (97.3% vs. 96.8%, P 0.82). Seroprevalence of rubella antibodies is high in HCW, but workers aged<30 years have a higher susceptibility (5.5%). Vaccination should be reinforced in HCW in this age group, due to the risk of nosocomial transmission and congenital rubella.

Serological survey of mumps immunity among health care workers in the Catalonia region of Spain.

Susceptible health care workers are at risk of acquiring and transmitting mumps to or from patients. A survey was carried out in 639 health care workers from tertiary public hospitals and primary care centers in the Catalonia region of Spain during 2009 to determine the prevalence of immunity to mumps among this group. The prevalence of immune health care workers was 87.5% (95% confidence interval, 84.7-89.9). Vaccination with 2 doses of vaccine should be reinforced in health care workers to minimize the risk of mumps transmission in health care settings.

Factors associated with the immune response to hepatitis A vaccination in HIV-infected patients in the era of highly active antiretroviral therapy.

INTRODUCTION: HIV seropositivity is considered a risk factor for complications in hepatitis A virus (HAV) infection. HAV vaccination schedules are widely implemented in HIV-infected patients, but the immune response remains impaired. METHODS: We analysed the response to vaccination (antiHAV titres ≥20IU/l) in 282 HIV-infected patients included in a standard (1440 Elisa Units (EU) at 0, 6 months) or rapidly accelerated schedule (720 EU at 0, 7, 21 days and 6 months) between 1997 and 2009. Factors associated with the response to vaccination were analysed using logistic regression. RESULTS: The overall response rate was 73.4%. Male sex (OR: 0.16, 95% CI 0.05-0.51) and hepatitis C virus co-infection (OR: 0.30, 95% CI 0.14-0.74) were associated with a lower probability of response. Protective antibody response was associated with a higher CD4/CD8 ratio (OR: 3.69, 95% CI 1.3-10.5) and having received two doses of standard schedule (compared with patients receiving only one dose of the same schedule) (OR: 2.51, 95% CI 1.22-5.15). Three doses of the rapidly accelerated schedule were not more effective than a single dose of 1440 EU (OR: 1.32, 95% CI 0.48-3.63). CONCLUSION: The low responses observed in patients receiving a single dose suggest the need to emphasize adhesion to vaccination protocols to avoid failure. The CD4/CD8 ratio may be considered as an immune status marker which could help to better choose the moment of vaccination. Our findings underscore the importance of identifying strategies that optimize the timing and effectiveness of hepatitis A vaccination in HIV-infected patients and of the need for further studies on individual factors such as sex and hepatitis C co-infection that may affect the response to vaccination. Likewise, the sub-optimal effectiveness of three doses of 720 EU in the rapidly accelerated schedule, if confirmed in future studies, might lead to a revision of the current schedule recommended for HIV-infected travellers.

Prevalence of susceptibility to tetanus and diphtheria in health care workers in Catalonia.

A seroprevalence study of tetanus and diphtheria was carried out in a sample of 537 health care workers in Catalonia. The prevalence of protective antibodies against tetanus was 93.9% (95% confidence interval: 91.5-95.7). The prevalence of protective antibodies against diphtheria was 46.4% (95% confidence interval: 42.1-50.7). Tetanus protection should be improved in health care workers born before 1975. The immune status against diphtheria was poor, with less than half of people born before 1975 correctly immunized.

A public-professional web-bridge for vaccines and vaccination: user concerns about vaccine safety.

Vacunas.org (http://www.vacunas.org), a website founded by the Spanish Association of Vaccinology offers a personalized service called Ask the Expert, which answers any questions posed by the public or health professionals about vaccines and vaccination. The aim of this study was to analyze the factors associated with questions on vaccination safety and determine the characteristics of questioners and the type of question asked during the period 2008-2010. A total of 1341 questions were finally included in the analysis. Of those, 30% were related to vaccine safety. Questions about pregnant women had 5.01 higher odds of asking about safety (95% CI 2.82-8.93) than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners (OR: 0.44, 95% CI 0.25-0.76). Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required.

[Susceptibility to varicella among health care workers. Acceptability and response to vaccination]. / Susceptibilidad a la varicela en personal sanitario. Aceptación y respuesta a la vacunación.

BACKGROUND AND OBJECTIVE: To determine the prevalence of health care workers (HCW) susceptibility to varicella zoster virus (VZV). As a secondary objective, we describe the immunogenicity and reactogenicity of the vaccine. SUBJECTS AND METHODS: A multicenter analytic cross-sectional study was conducted in 5 hospitals in Catalonia, Spain, in a total of 1,111 HCW, aged between 18-60 years. We studied the prevalence of anti-VZV antibodies (IgG) and obtained demographic, occupational and health related variables that were expected to be associated with immunogenicity, as well as past history of varicella. All susceptible HCW were vaccinated and we studied the immunogenicity (antibody detection) and reactogenicity of the 1st and 2nd doses of the vaccine. Detection of antibodies against VZV was obtained by ELISA. All negative results were confirmed with FAMA. RESULTS: Forty two subjects (3.8%) were negative. Susceptibility to VZV was associated (p<0.05) with decreased age (29.6 years ± 8.5 vs. 32,5 ± 9,3 in non-susceptible individuals), having fewer siblings and having no previous clinical history of varicella. Postvaccination detection tests with ELISA showed a seroconversion rate of 52 and 86% after the 1st and 2nd doses of the vaccine respectively, and 100% when using FAMA. There were no significant adverse events. CONCLUSIONS: Susceptibility to varicella among HCW is low. Positive past history of varicella is a good predictor of previous exposure to VZV, since 99% (687/696) of the individuals that declared having experienced the disease were immune. This would avoid prevaccination screening in nearly two thirds of HCW.

Influence of prior pneumococcal and influenza vaccination on outcomes of older adults with community-acquired pneumonia.

OBJECTIVES: To determine whether prior pneumococcal and seasonal influenza vaccination improves outcomes in older adults hospitalized for community-acquired pneumonia (CAP). DESIGN: Prospective, observational, multicenter study. SETTING: Five public hospitals providing universal free care to the whole population in three Spanish regions. PARTICIPANTS: Individuals aged 65 and older admitted to the hospital with CAP through the emergency department. MEASUREMENTS: Pneumococcal and influenza vaccination status. The primary study outcomes were intensive care unit (ICU) admission, length of hospital stay (LOS), and overall case-fatality rate. Outcome variables of individuals vaccinated with both vaccines were compared with outcomes of those who were unvaccinated. RESULTS: Two hundred thirty-eight individuals had received 23-valent pneumococcal polysaccharide vaccine and seasonal influenza vaccination and were compared with 195 unvaccinated individuals. No differences were found with respect to combined antibiotic therapy between groups (38.0% vs 39.7%; P = .80). Similar percentages of vaccinated and unvaccinated individuals required ICU admission (7.2% vs 8.2%; P = .69). Mean LOS was significantly shorter in vaccinated individuals (9.9 vs 12.4 days; P = .04). Overall case-fatality rates were similar in both groups (5.9% vs 5.1%; P = .73). After adjustment, LOS, risk of ICU admission, and overall case-fatality rate were not associated with prior pneumococcal and seasonal influenza vaccination. CONCLUSION: The clinical outcomes of vaccinated older adults hospitalized with CAP were not better than those observed in unvaccinated individuals.

Vaccination strategies against hepatitis A in travelers older than 40 years: an economic evaluation.

BACKGROUND: In recent years, the number of travelers aged >40 years who acquire hepatitis A while traveling has increased. Therefore, there is a need to review hepatitis A vaccination protocols in travelers. The aims of the study were to assess immunity levels to hepatitis A virus (HAV) in international travelers >40 years and to determine the least costly immunization strategy. METHODS: A serological examination of HAV antibodies in 427 international travelers aged >40 years traveling endemic zones was carried out. The prevalence of antibodies in each age group was assessed. The costs of two preventive strategies, direct vaccination of all subjects (independent of the immune status) or screening and subsequent vaccination of susceptible subjects were compared. The critical value of prevalence (CVP) (the value at which the costs for the two strategies are equal) was calculated. RESULTS: Total prevalence of HAV antibodies was 78.9% [95% confidence interval (CI): 74.8-82.5] and was 80.0% (95% CI: 73.8-85.2) in men and 77.9% (95% CI: 71.9-83.2) in women. There was a positive association with age. In the 40 to 49, 50 to 59, 60 to 69, and 70 to 95 years age groups, the prevalence rates were 62.6 (95% CI: 53.8-71.5), 76.8 (95% CI: 70.0-82.7), 91.7 (95% CI: 85.2-95.6), and 97.5% (95% CI: 87.4-99.6), respectively. The CVP was 58.4% using two doses of vaccine. CONCLUSIONS: The CVP was lower than the prevalence rate found in our international travelers. Therefore, we recommend systematic screening for HAV antibodies before selective vaccination of international travelers aged >40 years traveling to hepatitis A endemic zones.

Validity of self-reported pneumococcal vaccination status in the elderly in Spain.

The objective of this study was to evaluate the validity of information reported by the elderly on 23-valent pneumococcal polysaccharide vaccine (23vPPV) vaccination status. A cross-sectional, observational study was carried out in patients aged >or=65 years admitted to five Spanish hospitals. Data on 23vPPV vaccination history were obtained through interview of the patient or close relative and review of written medical information. The validity of the patient self-report was compared to the written medical information by calculation of the sensitivity, specificity, concordance, positive predictive value (PPV) and negative predictive value (NPV). A total of 2484 patients were initially included of whom 1814 patients (73%) responded about their vaccination status. The global sensitivity of the patient self-report was 0.74 and the specificity 0.95. The PPV was 0.92, the NPV 0.84 and the concordance 87. Vaccination cards and centralized vaccination registries in primary health care centres and hospitals should be potentiated in order to ensure that neither more nor less vaccinations are administered than are necessary.

Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial.

A multicentre, randomized, phase III clinical trial in 5071 healthy adults was conducted to evaluate the safety and reactogenicity of a 15 microg HA dose of a candidate oil-in-water emulsion-based adjuvant system (AS)-adjuvanted split-virion H5N1 (AS-H5N1) vaccine compared to a licensed seasonal influenza vaccine, Fluarix.(1) Stringent criteria were used to evaluate adverse events and reactogenicity profile. Overall, 96.7% of the 5071 vaccinated subjects completed the study. Significantly more participants in the AS-H5N1 vaccine group reported general or local adverse events. Pain was the most common symptom in both treatment groups. Less than 1% of subjects withdrew from the study due to adverse events and no withdrawals were due to serious adverse events related to vaccination. The safety and reactogenicity profile of the AS-H5N1 candidate vaccine can be considered clinically acceptable in the context of its use against pandemic influenza.

Solid organ transplantation and response to vaccination.

Although early vaccination is recommended in candidates for solid organ transplantation (SOT), consensual protocols do not yet exist. We applied an SOT vaccination protocol in the Hospital Clinic of Barcelona (Spain). Serology was performed before and after vaccination and compliance with the vaccination schedule was analysed during the period 2003-2004. Two hundred and thirty seven patients (72.9% male; mean age 56.31 years, range 19-72) were included. A total of 74.5% of subjects susceptible to hepatitis B virus infection responded to hepatitis B vaccination. Most patients were protected against hepatitis A, varicella, measles, rubella and mumps. The vaccine protocol was implemented satisfactorily and the administration of two courses of hepatitis B vaccine was shown to be effective.

Reactogenicity profile of a combined hepatitis A and B vaccine in clinical practice: a naturalistic study in adult travellers.

A prospective observational naturalistic study was conducted to assess the reactogenicity of the combined hepatitis A and hepatitis B (HAB) vaccine in a real-life setting. All healthy candidates for HAB vaccination attending an adult vaccination centre between October 1998 and February 2000 were invited to participate in the study. A follow-up diary card was provided to subjects to record local and general symptoms during a 4-day follow-up. Intensity was graded from 1 to 3. Redness was recorded as presence or absence. Fever was defined as axillar temperature > or =37.5 degrees C and grade 3 >39.0 degrees C. For all other symptoms, grade 3 was defined as an adverse reaction preventing normal everyday activities; 998 subjects (74% females), mean age (+/-S.D.) of 23 years (+/-4.5) (range: 11-54 years) agreed to participate. At first immunization 92% were <30 years old. Grade 3 pain and swelling was recorded in 1.2% and 0.3% of local symptom sheets completed, respectively; 438 subjects received the HAB vaccine alone (group 1) whereas 560 received at least one concomitant vaccine (group 2). In 45%, 27%, 18% and 10% of subjects the HAB vaccine was coadministered with 1, 2, 3 or 4 to 6 vaccines (mainly Td adult-type, typhoid, MMR and IPV vaccine). Grade 3 pain and swelling were recorded in 1.2% & 0.3% of symptom sheets (SS), respectively. In group 1, any fever and grade 3 fever was recorded in 3.5% and 0.1% of SS. Group 1 versus 2 had a lower risk for any fatigue (p=0.0002; OR=0.617) and any malaise (p=0.0076; OR=0.693) but not for grade 3 symptoms. In conclusion, our study showed that the HAB vaccine is well tolerated in adults either alone or coadministered with other vaccines in the routine clinical practice.

Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients.

BACKGROUND: Due to their impaired immune system, patients with renal insufficiency have a suboptimal response to hepatitis B (HB) vaccination and frequent boosters are needed to maintain protection. GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population. METHODS: In an open, randomized clinical trial conducted in pre-hemodialysis (documented creatinine clearance < or =30 mL/min) and hemodialysis patients, over 15 years of age and naïve for HB, the immunogenicity and safety of single doses of HB-AS04 (Fendrix, GlaxoSmithKline Biologicals) were compared to double doses of commercially available HB vaccine (Engerix, GlaxoSmithKline Biologicals) administered at 0, 1, 2, and 6 months, and followed-up for 36 months. RESULTS: The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population, with 74% versus 52% of subjects seroprotected at month 3. After the vaccination course, seroprotection rates increased to 91% versus 84% in the HB-AS04 and standard vaccine groups, respectively. Differences persisted up to 36 months post-vaccination (73% vs. 52%, respectively). Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points. During the follow-up, significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels (11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the standard vaccine group, respectively, P = 0.014). The HB-AS04 was more locally reactogenic than the standard immunization regimen, with pain at the injection site occurring with 41% of HB-AS04 doses versus 19% of standard vaccine doses. The occurrence of grade 3 pain was less than 1% in both groups and all events resolved within the 4-day follow-up period. CONCLUSION: The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid, enhanced, and longer seroprotection to these immunocompromised patients at risk for HB infection.