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.
To review the risk of in utero infection through amniocentesis in women with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
Fetal and neonatal morbidity and mortality.
Review articles, meta-analyses, and MEDLINE searches from 1966 to 2002 for English-language articles related to amniocentesis, fetal and neonatal infection, and hepatitis B, hepatitis C, or HIV.
The evidence collected was reviewed by the Genetics Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and quantified using the Evaluation of Evidence guidelines developed by the Canadian Task Force on the Periodic Health Exam.
1. The risk of fetal hepatitis B infection through amniocentesis is low. However, knowledge of the maternal hepatitis B e antigen status is valuable in the counselling of risks associated with amniocentesis. (II-1C) 2. Amniocentesis in women infected with hepatitis C does not appear to significantly increase the risk of vertical transmission, but women should be counselled that very few studies have properly addressed this possibility. (II-2C) 3. In HIV-positive women all noninvasive screening tools should be used prior to considering amniocentesis. (II-2D) 4. For women infected with hepatitis B, hepatitis C, or HIV, the addition of noninvasive methods of prenatal risk screening, such as nuchal translucency, triple screening, and anatomic ultrasound, may help in reducing the age-related risk to a level below the threshold for genetic amniocentesis. (II-2C) 5. For those women infected with hepatitis B, hepatitis C, or HIV who insist on amniocentesis, every effort should be made to avoid inserting the needle through the placenta. (II-1B) VALIDATION: These guidelines have been approved by the SOGC Genetics Committee, SOGC Executive, and SOGC Council.
The Society of Obstetricians and Gynaecologists of Canada.
During the 12 years from January, 1977, to December, 1988, the Hamilton Centre of the Canadian Red Cross Society (CRCS) Blood Transfusion Service screened 98,712 pregnant patients for hepatitis B surface antigen (HBsAg) and identified 120 positives (0.12%). The number of positives ranged from six to 16 per year. We were able to trace and enroll 65 mothers (54%) and 96 of their children in the follow-up study. The majority of the women were between 20 and 30 years of age (95.4%) and married (86%), and about one-half were employed outside the home. Sixty-five percent were white and 34% Asian, and 20 countries were listed as their places of origin. Hepatitis B immune globulin (HBIG) was available for neonatal immunization since 1977 and combined with vaccine since 1982. Of the 96 candidates for HBIG, 60 (63%) received HBIG within 24 hr, one after 3 months, four unknown, and 31 did not receive it. Of the 56 candidates for vaccination from 1982 to 1989, 26 (46%) received three doses, seven had two doses, eight had one dose, one was unknown, and 14 had none. HBsAg tests were performed on 69 children (71.8%) and anti-HBs on 61 (63.5%). Four of the children are HBsAg positive, 31 have anti-HBs, and 31 have no detectable antibodies. All four HBsAg positives had not received vaccine, and only one had received HBIG. Of the children positive for hepatitis B surface antibodies, five had received no immunization and therefore had been subclinically infected.(ABSTRACT TRUNCATED AT 250 WORDS)
To assess a hepatitis B vaccination program offered to all grade 6 students in British Columbia in 1992.
British Columbia, Canada.
All grade 6 students were offered vaccine. Subsets of 454 and 259 students participated in studies of minor adverse events and seroresponse, respectively.
The vaccine used was Engerix-B, 20 micrograms, given at intervals of 0, 1, and 6 months.
Province-wide acceptance and series completion rates and reports of severe adverse events. Minor adverse events and immunogenicity in subsamples.
A total of 127,922 vaccine doses were administered. Initial enrollment totaled 43,358 students or 95.4% of those eligible. The series was completed by 41,594 students (95.6%). Minor adverse events were infrequent in the cohort assessed: no absenteeism or physician visits resulted from vaccination. Sixty-nine reported severe adverse events met surveillance definitions, the major categories being injection site reactions (23% of reports), fainting (20%), and rashes (17%). There was one instance of anaphylaxis. Only 13 of these events resulted in recommendations to discontinue the series. Of students tested following the series, 98% had levels of antibody to hepatitis B surface antigen considered to be protective (> or = 10 IU/L), the geometric mean titer being 690 IU/L (95% confidence interval, 498 to 957 IU/L).
Our experience indicates that school-based programs for universal vaccination of preadolescents can be highly acceptable and efficient.
Comment In: JAMA. 1995 Oct 18;274(15):1242-37563516
560 bones were harvested by The Turku Bone Bank between 1972-1995. It was started with massive allografts for bone tumor surgery, but today most are femoral heads for hip revision surgery. The increase in harvested bones nearly trebled from 1984-1989 to 1990-1995. Only 1 positive hepatitis C test was found. There were no hepatitis B or HIV positive donors. The incidence of discarding after screening was 24%, with positive bacterial growth (8%, usually Staphylococcus epidermidis) as the commonest reason. 2 massive grafts with negative cultures when harvesting were positive after thawing and resulted in deep infection. 369 allografts were transplanted. The infection rate of massive allografts for bone tumor surgery was 5/63 in 1973-1995, and 2/52 in 1985-1995. The infection rate for hip revision surgery was 3.4%. The clinical functional results correspond to those reported in larger international series.