Hepatitis: Verstraeten T

Zepp F, Schmitt HJ, Cleerbout J, Verstraeten T, Schuerman L, Jacquet JM. · University Hospital, Department of Pediatrics, Johannes Gutenberg University, Langenbeckstrasse 1, 55131 Mainz, Germany. · Expert Rev Vaccines. · Pubmed #19485747 No free full text.

Abstract: Combination vaccines that include multiple antigens within one formulation are now widely accepted as an effective means of eliciting protection against several diseases at the same time. Owing to improvements in quality and convenient modes of administration, they have become part of routine pediatric practice. Hexavalent vaccines, including diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b antigens represent the latest advance in the development of combination vaccines. Over 8 years since its first licensure, this review looks at the immunogenicity, efficacy and safety profile of the only hexavalent pediatric vaccine currently in use--Infanrix hexa (diphtheria, tetanus, acellular pertusis-hepatitis B virus-inactivated poliovirus vaccine/Haemophilus influenzae type b vaccine [DTPa-HBV-IPV/Hib]; GlaxoSmithKline Biologicals, Rixensart, Belgium)--through published clinical trials and postmarketing surveillance data. These data show DTPa-HBV-IPV/Hib to be highly immunogenic and well tolerated across a range of different primary and booster vaccination schedules, as well as when administered concomitantly with other licensed vaccines (e.g., pneumococcal conjugate vaccine). Additional issues surrounding the use of hexavalent vaccines are also reviewed.

DeStefano F, Verstraeten T, Chen RT. · Centers for Disease Control and Prevention, Atlanta, Georgia 30341-3724, USA. · Expert Rev Vaccines. · Pubmed #12901584 No free full text.

Abstract: The possibility that hepatitis B vaccine may cause or exacerbate multiple sclerosis stems from several case reports of onset or recurrence of symptoms of CNS demyelination shortly following vaccination. It is difficult, however, to infer causation from individual case reports since they may simply represent coincidental temporal associations with vaccination. There is only weak, nonspecific evidence to support the biological plausibility of an association between hepatitis B vaccine and multiple sclerosis. Epidemiological studies have found that hepatitis B vaccine does not increase the risk of developing multiple sclerosis or cause exacerbations. The US Institute of Medicine and other review panels have concluded that the evidence favors rejection of a causal association between hepatitis B vaccine and multiple sclerosis.

Asturias EJ, Mayorga C, Caffaro C, Ramirez P, Ram M, Verstraeten T, Clemens R, Halsey NA. · Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, United States. · Vaccine. · Pubmed #19464546 No free full text.

Abstract: Ladino and native Indian Guatemalan infants developed high rates (96-100%) of protective antibodies after receiving conjugate Haemophilus influenzae type b and hepatitis B vaccines at 2, 4 and 6 months of age. Native Indian infants developed significantly (p<0.01) higher geometric mean anti-PRP (polyribose-ribitol-phosphate) and anti-HBs (anti-hepatitis b surface) antibody concentrations than Ladino infants. Malnourished infants generally responded as well as healthy infants. Unvaccinated native Indian infants had higher rates of developing anti-PRP antibodies than Ladino infants by seven months of age.

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. · GlaxoSmithKline Biologicals, Rixensart, Belgium. · Vaccine. · Pubmed #18845199 No free full text.

Abstract: Newly licensed vaccines against human papillomavirus (HPV) and hepatitis B (HBV), and several vaccines in development, including a vaccine against genital herpes simplex virus (HSV), contain a novel Adjuvant System, AS04, composed of 3-O-desacyl-4' monophosphoryl lipid A and aluminium salts. Given the background incidence of autoimmune disorders in some of the groups targeted for immunisation with these vaccines, it is likely that autoimmune events will be reported in temporal association with vaccination, even in the absence of a causal relationship. The objective of this integrated analysis was to assess safety of AS04 adjuvanted vaccines with regard to adverse events (AEs) of potential autoimmune aetiology, particularly in adolescents and young adults. All randomised, controlled trials of HPV-16/18, HSV and HBV vaccines were analysed in an integrated analysis of individual data (N = 68,512). A separate analysis of the HPV-16/18 vaccine trials alone was also undertaken (N = 39,160). All data were collected prospectively during the vaccine development programmes (mean follow-up of 21.4 months), and included in the analysis up to a pre-defined data lock point. Reporting rates of overall autoimmune events were around 0.5% and did not differ between the AS04 and control groups. The relative risk (AS04/control) of experiencing any autoimmune event was 0.98 (95% confidence intervals 0.80, 1.21) in the integrated analysis and 0.92 (0.70, 1.22) in the HPV-16/18 vaccine analysis. Relative risks calculated overall, for disease category or for individual events were close to 1, and all confidence intervals around the relative risk included 1, indicating no statistically significant difference in event rates between the AS04 and control groups. This integrated analysis of over 68,000 participants who received AS04 adjuvanted vaccines or controls demonstrated a low rate of autoimmune disorders, without evidence of an increase in relative risk associated with AS04 adjuvanted vaccines.

Kalies H, Grote V, Verstraeten T, Hessel L, Schmitt HJ, von Kries R. · Department of Pediatric Epidemiology, Institute for Social Pediatrics and Adolescent Medicine of Ludwig-Maximilians-University, Munich, Germany. · Pediatr Infect Dis J. · Pubmed #16732148 No free full text.

Abstract: BACKGROUND: In Germany, Haemophilus influenzae type b (Hib), polio and hepatitis B (HBV) vaccines have been combined with diphtheria, tetanus and acellular pertussis vaccines. We examined whether the use of combination vaccines has improved the timing of these vaccinations. METHODS: Vaccination information was obtained from representative nationwide telephone interviews about 2701 children born from 1996 through 2003 in Germany. We assessed up-to-date vaccination as the percentage of children vaccinated by 3, 5 and 15 months for the first dose, full primary series and full immunization, respectively. We compared results over periods when different combination vaccines were used. We also compared median age at first dose, full priming and full immunization for children receiving different types of combination vaccines. RESULTS: During the study period, monovalent vaccines were replaced by higher-valent combination vaccines. With the change from mono- to 4-, 5- and 6-valent vaccines, up-to-date vaccination increased for Hib, polio and HBV. Median age at immunization improved by 0.5 month for Hib, 0.4 month for polio and 0.9 month for HBV at the first dose and 2.2 months for Hib, 3.2 months for polio and 1.4 months for HBV at full immunization when comparing hexavalent with monovalent vaccines. Median age for 4-5-valent vaccines was intermediate. The difference between monovalent and 6-valent vaccines remained significant after stratifying/adjusting for the effect of birth cohorts. CONCLUSION: Combination vaccines are usually advocated for reducing the number of injections. In Germany, however, the use of combination vaccines has also significantly improved timeliness of immunizations.

Verstraeten T, Davis R, DeStefano F. · Epidemic Intelligence Service (EIS) Program, Epidemiology Program Office, Centers for Disease Control and Prevention, Altanta, GA, USA. · Med Hypotheses. · Pubmed #16023300 No free full text.

Abstract: Following allegations that Hepatitis B vaccination causes or triggers multiple sclerosis (MS), several epidemiological studies have been conducted to evaluate the association between MS and vaccination. In one study conducted in the US, a significant protective effect on the development of MS was observed for tetanus immunization. We reviewed the medical literature and found two additional recent studies, as well as several older studies, which also observed a significant protective effect of tetanus immunization on the development or progression of MS. Furthermore, decreased humoral and cellular immunity to tetanus toxoid has been observed among MS patients. We postulate that naturally acquired or vaccine-induced immunity to tetanus has a protective effect against the development and progression of MS. We also postulate that this link to tetanus is in part responsible for the gender, age, geographic and socio-economic distribution of MS, as well as its pattern among migrants. The biological basis for this protective effect could be an unspecific boost of bystander suppression of auto-immunity as shown for other infections. Our hypothesis can be tested in several ways. The simplest approach would be to compare tetanus exposure and MS occurrence on a population level. Stronger support would come from the re-analysis of previous studies that have information at the individual level on both tetanus exposure, whether induced or natural, and on the development of MS. Laboratory evidence could be sought by testing the effect of tetanus toxoid on experimental allergic encephalomyelitis, the experimental animal model of MS.

DeStefano F, Verstraeten T, Jackson LA, Okoro CA, Benson P, Black SB, Shinefield HR, Mullooly JP, Likosky W, Chen RT, Anonymous00087. · National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. · Arch Neurol. · Pubmed #12707063 links to  free full text

Abstract: BACKGROUND: Several case reports of the onset or exacerbation of multiple sclerosis or other demyelinating conditions shortly after vaccination have suggested that vaccines may increase the risk of demyelinating diseases. OBJECTIVE: To evaluate the association between vaccination and onset of multiple sclerosis or optic neuritis. DESIGN: Case-control study involving cases of multiple sclerosis or optic neuritis among adults 18 to 49 years of age. Data on vaccinations and other risk factors were obtained from computerized and paper medical records and from telephone interviews. SETTING: Three health maintenance organizations. PARTICIPANTS: Four hundred forty case subjects and 950 control subjects matched on health maintenance organization, sex, and date of birth. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Onset of first symptoms of demyelinating disease at any time after vaccination and during specified intervals after vaccination (<1 year, 1-5 years, and >5 years). RESULTS: Cases and controls had similar vaccination histories. The odds ratios (95% confidence intervals), adjusted for potential confounding variables, of the associations between ever having been vaccinated and risk of demyelinating disease (multiple sclerosis and optic neuritis combined) were 0.9 (0.6-1.5) for hepatitis B vaccine; 0.6 (0.4-0.8) for tetanus vaccination; 0.8 (0.6-1.2) for influenza vaccine; 0.8 (0.5-1.5) for measles, mumps, rubella vaccine; 0.9 (0.5-1.4) for measles vaccine; and 0.7 (0.4-1.0) for rubella vaccine. The results were similar when multiple sclerosis and optic neuritis were analyzed separately. There was no increased risk according to timing of vaccination. CONCLUSION: Vaccination against hepatitis B, influenza, tetanus, measles, or rubella is not associated with an increased risk of multiple sclerosis or optic neuritis.

DeStefano F, Verstraeten T. · No affiliation provided · N Engl J Med. · Pubmed #11195798 No free full text.

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