An open-label randomized study was undertaken to compare a 2-dose regimen (Months 0 and 6) of hepatitis B surface antigen (HBsAg) vaccine formulated with a novel adjuvant (HBsAg/AS04) with a standard 3-dose regimen (Months 0, 1 and 6) of licensed recombinant HBsAg vaccine in terms of immunogenicity and reactogenicity when administered to healthy subjects aged between 15 and 40 y. At 1 and 6 months after the full vaccination course there was a 100% seroprotection rate (anti-HBs > or = 10 mIU/ml) with the HBsAg/AS04 vaccine, compared with a 99% response rate with the licensed vaccine. The corresponding geometric mean titres were significantly higher for the novel vaccine compared to the standard vaccine: 15,468 and 2,745 mIU/ml at Months 7 and 12 vs. 6,274 and 1,883 mIU/ml, respectively. There was a higher prevalence of local symptoms with the adjuvant vaccine (90% of doses) than with the standard vaccine (48% of doses). However, these symptoms (pain, swelling and redness) were predominantly of mild-to-moderate intensity and resolved rapidly without treatment. A 2-dose regimen of the new HBsAg/AS04 adjuvant vaccine therefore compared favourably to the standard regimen in healthy young adults. It is anticipated that the simplified vaccination schedule may improve compliance and reduce costs.
Alanine aminotransferase (ALT), gamma-glutamyl-transferase and hepatitis B core antibodies were evaluated as donor markers in a prospective study of 685 open-heart surgery patients. Of these three surrogate markers, only an ALT level greater than or equal to 2 SD above the log mean had a significant association with recipient non-A, non-B hepatitis (NANBH, p = 0.02). Antibodies to the hepatitis C virus (anti-HCV) were detected by an enzyme immunoassay in 7 of the 136 units transfused to the 11 NANBH patients and 29 of 3,650 not associated with hepatitis (p less than 0.001). Calculated from this subgroup of donors, the anti-HCV test would have a 15.6% positive predictive value with 0.92% donor loss and thus is superior as a primary screening marker to all the three surrogate tests. The predictive value could be substantially increased by subsequent ALT testing or by the use of a recombinant immunoblot anti-HCV assay.
This study describes an outbreak of hepatitis B primarily among intravenous drug users in Iceland which has a population with a very low incidence of hepatitis B virus infection. The incidence of acute hepatitis B is generally low in the Nordic Countries, in the order of one to five cases per 100,000 people per year. Between 1989 and 1992 there was an outbreak of hepatitis B virus infection primarily among the intravenous drug user (IVDU) population in Iceland. At the Department of Medical Virology, University of Iceland there were 44 cases of acute hepatitis B identified during the peak year 1990, an incidence of 16.9 cases of acute hepatitis B per 100,000 people. 63.6% of these were known to be IVDUs. The seroprevalence of the hepatitis B core antibody (anti-HBc) marker was assessed among 1100 randomly selected individuals. The average prevalence of this marker was 2.9% and rose from zero at the age of 15 and younger to 6.5% at the age of 65 and older. Among IVDUs attending a detoxification clinic in 1990 the prevalence of the anti-HBc was 32%. In contrast, those attending the same clinic, due to alcoholism only, did not have a significantly higher prevalence of anti-HBc than the group used for comparison.
Seamen constitute a special group of international travellers who may run an increased risk of contracting hepatitis, because of visits to foreign ports and the particular environment on board ship. The purpose of the survey was to assess the prevalence of serological markers for hepatitis A, B and C virus infection among seamen and to identify present and previous risk factors for infection. 515 seamen were studied. The prevalence of antibodies against hepatitis A was 0.3% in subjects below 40 years of age, increasing with age above 40 years, and highest among those who had sailed in international trade. The prevalence of antibodies against hepatitis B was 2.7% in subjects below 40 years of age, increasing to 35.7% in the group above 60 years of age. Hepatitis C antibodies occurred in 1.2%. Vaccination of sailors against hepatitis A should follow the same recommendations as to other travellers. The prevalence of hepatitis B was higher than in reference groups of non-seamen but, because hepatitis B is only one of many blood-borne diseases, prevention should be directed towards changes in behaviour rather than vaccination, except for special groups. Young seamen in international trade were found to be most at risk of contracting sexually transmitted diseases.
Sera from 521 residents of an institution for the mentally retarded near Helsinki, Finland were examined by a hemagglutination assay to determine the distribution and titers of antibodies to hepatitis B surface antigen (anti-HBs). 36.1% were found to contain anti-HBs. Factors were identified which are related to the presence or absence of anti-HBs in this population. A documented past history of hepatitis, living in "asocial" wards in which at least one HBsAg carrier was present, long institutionalization (is greater than 10 yrs.), admission to the institution between ages 5 and 19, a present age between 20 and 39, and being male were associated with the presence of anti-HBs. 43.5% of the males but only 22.2% of the females had antibody. Down's syndrome patients had lower titers but not lower frequencies of anti-HBs than the non Down's patients.
In an anonymous survey, 433 sera from Canadian individuals of selected categories were tested for the presence of antibody to hepatitis C virus (HCV) using a recombinant antigen-based immunoassay. About 50% of intravenous drug abusers (IVDA), 10% of transfusion recipients and an overall average of 7.9% of male homosexuals were reactive for antibody to HCV. Individuals with jaundice and negative hepatitis B virus (HBV) serology were not reactive for antibody to HCV compared with 26.7% of those with positive HBV serology. Similarly 58% of male Federal prisoners with positive HBV serology were also HCV-antibody reactive compared with 15% of those with negative HBV serology. A prevalence of 1.2% was recorded for individuals not in any of the above groups. Of 433 sera, 92 were reactive and the discrimination in absorbance values between reactive and not reactive samples was good except for 13 sera, eight of which gave values considerably higher than the average negative value and five which were just above the positive threshold.
A matched-pair, cross-sectional study of lymphocyte and serological parameters associated with acquired immune deficiency syndrome (AIDS) in 189 randomly chosen, ostensibly healthy adult Haitian immigrants residing in Montreal matched for sex, age (within 5 years), and neighborhood of residence to 189 non-Haitian (Caucasian) controls was done in 1983-1984. Three years later (1986-1987), 41 of the Haitian study subjects and 83 of the non-Haitian controls participated in a follow-up study centered on lymphocyte parameters. A significantly greater number of Haitians than controls had produced antibodies to Toxoplasma gondii. In addition, a greater percentage of the Haitians than the controls were also producing antibodies to two other opportunistic pathogens frequently encountered in AIDS, cytomegalovirus and hepatitis B virus, implying that the Haitians in general had had greater exposure to a variety of infectious agents than had the controls. A few study participants were producing antibodies against two viruses that are related to the human immunodeficiency virus-type 1 (HIV-1), the human T-cell lymphotropic viruses I and II (HTLV-I and -II). Two Haitians and one control were producing antibodies against HTLV-I. One study subject and four controls were HTLV-II seropositive. The most interesting and surprising finding was that four (2.1%) of the Haitian study subjects but none of the controls were seropositive for HIV-1. These individuals, two of whom were women and two men, were asymptomatic. Although their individual lymphocyte parameter values fell in the normal range, as a group they had statistically significantly lower average values for their lymphocyte parameters than did the HIV-seronegative Haitian study objects.(ABSTRACT TRUNCATED AT 250 WORDS)
The authors discuss a tentative approach to the choice of criteria indicating the optimal suitability of different solid-phase carriers made of polystyrene for use in the enzyme immunoassay (EIA), viz. the dependence of specificity, sensitivity, reproducibility and reliability of EIA results on the adsorption properties, transparency expressed in percent and transparency variations of the plates under test. The evaluation of the carriers by four parameters is proposed with the use of assay plates manufactured by Nunc A/S (Denmark) for control. To ensure the objective evaluation of the suitability of polystyrene plates for use in EIA, the choice of uniform criteria is necessary.