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Biomedical subjects

J N Zuckerman

Publications and source records attributed to J N Zuckerman.

At least 19 recordsLinked to original sources
PubMed2004

Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04.

The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.

Adjuvants, Immunologic↗
PubMed2002

A new accelerated vaccination schedule for rapid protection against hepatitis A and B.

BACKGROUND: Increasing travel stresses the requirement for rapid protection against infections such as hepatitis A and B. METHODS: This randomised, multicentre study investigated an accelerated vaccination schedule using a combined hepatitis A and B vaccine (Twinrix, Smithkline Beecham Biologicals) compared with simultaneous administration of the two corresponding monovalent vaccines. The combined vaccine was administered on days 0, 7 and 21, whereas the comparison group received hepatitis A vaccine on day 0 and hepatitis B vaccine on days 0, 7 and 21. All subjects received booster vaccination at month 12. RESULTS: At month 1, 100% of subjects in the combined group and 99% of the controls were seropositive for anti-HAV antibodies. The corresponding seroprotection rates for anti-HBs antibodies were 82.0 and 83.9%, respectively. Examination of the 95% confidence intervals (CIs) for the treatment differences showed the two vaccines to be equivalent in terms of immunogenicity 1 week after the initial vaccination course. Just prior to the booster, the seropositivity rate for anti-HAV was 96.2% in the combined group and 95% in the control group. For anti-HBs, this was 94 and 91.6%, respectively. All subjects were seropositive for anti-HAV and seroprotected against hepatitis B at month 13. The anti-HAV GMCs were 9571mIU/ml with the combined vaccine and 5206mIU/ml in control subjects. The anti-HBs titre was 26002 and 29,196mIU/ml, respectively. Both groups had a similar reactogenicity profile. CONCLUSIONS: The accelerated schedule of the combined vaccine provides a good immune response against hepatitis A and B antigens and is suitable for last minute immunisation.

Adolescent↗
PubMed2001

Management of hepatitis B virus infections in two gibbons and a western lowland gorilla in a zoological collection.

Since 1996, three primates newly arrived at London Zoo have been found to be infected with hepatitis B virus. The species involved were white-cheeked gibbons (Hylobates leucogenys leucogenys and Hylobates leucogenys siki) and a western lowland gorilla (Gorilla gorilla gorilla). The protocols for the practical management of these cases, including the immunisation of susceptible non-human primates and the staff with recombinant hepatitis B vaccine are described, and the origin and evolution of hepatitis B infection in primates are discussed.

Animals↗
PubMed2001

Evaluation of a new hepatitis B triple-antigen vaccine in inadequate responders to current vaccines.

In this double-blind, randomized, controlled study, healthcare professionals with a history of inadequate response to currently available single-antigen hepatitis B vaccines confirmed by measuring hepatitis B surface antibody titer before entry to the study were revaccinated with a 20-microg dose either of a novel triple-antigen (S, pre-S1, and pre-S2) recombinant vaccine or of a present single-antigen (S only) vaccine. Hepatitis B surface antibody titers were measured 8 weeks' post revaccination. A total of 925 individuals were randomized and vaccinated, of whom 915 (98.9%) completed the study and were included in the efficacy analysis. A single dose of the new triple-antigen hepatitis B vaccine (Hepacare) produced a successful response in over three quarters of these subjects who had not mounted an adequate response to current vaccines. The antibody response was statistically significantly superior (P =.002) to that after a single dose of current vaccines. An evaluation of the overall response showed that only the triple-antigen vaccine was able to raise the average antibody response (geometric mean titer [GMT]) to over 100 IU/L. The superior effect of the new vaccine was most pronounced in subjects who were previously complete nonresponders to currently available hepatitis B vaccines. Both vaccines were well tolerated and had similar safety profiles. This study demonstrated that in healthcare workers who had responded inadequately to at least a full course of immunization (median, 5 doses), a single 20-microg dose of a new triple-antigen vaccine induced protective antibody level in more vaccinees (P =.002) and increased the average antibody titer (GMT) in those protected successfully to a greater degree (P <.001) than a further attempt with a current vaccine (Engerix-B).

Adult↗
PubMed2001

Inadequate protection against yellow fever of children visiting endemic areas.

The guidelines of the World Health Organization call for immunization against yellow fever at least 10 days before travel to endemic areas. The goal of this study was to determine whether these guidelines have been applied in 2 travel clinic settings in teaching hospitals in Israel and the United Kingdom specifically for children traveling to endemic areas. Two groups of children aged 9 months to 15 years (n = 98), who were planning to travel to yellow fever-endemic areas, were evaluated regarding characteristics related to the administration of yellow fever vaccine before travel. Overall, 19 children in both clinics (19.4%; 95% confidence interval, 12.1-28.6) had received their yellow fever vaccination < 10 days before departure (no interclinic difference). Eleven of these children received the vaccine < 7 days before departure. We found that the World Health Organization guidelines for yellow fever vaccination are frequently not followed. An initiative to explain to the public the importance of vaccination well before travel to endemic areas should be undertaken.

Adolescent↗
PubMed2000

Current topics in hepatitis B.

Over two billion people around the world have been infected with hepatitis B virus, of whom over 350 million are chronic carriers. Some 25% of carriers develop progressive liver disease. The annual mortality from hepatitis B infection and its sequelae is 1-2 million people worldwide.The following current topics are reviewed: immunization strategies against hepatitis B and the kinetics and antibody response; the controversy on screening blood donors for anti-core antibodies; mutations of hepatitis B surface antigen, including evidence that not all such mutants are detectable by current laboratory tests and, finally, the introduction of second generation nucleoside analogues for treatment of chronic hepatitis B infection, including treatment of patients with decompensated liver disease and liver transplantation.

Antiviral Agents↗
PubMed1999

The influence of host factors and immunogenetics on lymphocyte responses to Hepagene vaccination.

We have shown that both demographic and immunogenetic factors are involved in the immune responses of Hepagene vaccinated individuals who were persistent nonresponders to 'S' containing hepatitis B vaccines. The HLA-DRB1 0701; DQB1 0202 genotype was found to be associated with a decline of anti-HBs antibodies (anti-HBs) and were frequent in those individuals who remained nonresponders following booster vaccination. Contrary to previously published 'S' vaccination data, Hepagene stimulated T-cell responses showed a lack of correlation with the humoral responses. Limiting dilution analysis demonstrated that the cellular immune response is associated with the kinetics of exposure to Hepagene rather than magnitude of the anti-HBs response. It remains that despite the inclusion of the pre-S proteins 74% nonresponder vaccinated individuals failed to produce > 100 IU/l of anti-HBs. However, these were persistent nonresponders and it was therefore encouraging that two doses of Hepagene did seroconvert (> 10 IU/L) 61% of this difficult group.

Adult↗
PubMed1999

Human leukocyte antigens influence the immune response to a pre-S/S hepatitis B vaccine.

In this study we investigated the effects of a single pre-S/S (Hepagene) revaccination in a large population of multiple 'S' vaccinated anti-HBs antibody nonresponder individuals (< 3 IU/l). We investigate the influence of vaccine dose (5, 10, 20 and 40 micrograms/ml), number of previous 'S' containing vaccinations and the individuals HLA genotype on both B- and T-cell responses. We show that 76% of persistently nonresponder individuals produce anti-HBs antibody (> 3 IU/l) following a single revaccination with Hepagene. This anti-HBs antibody response was dose dependent. The group that received 5 micrograms/ml of Hepagene vaccine produced significantly less anti-HBs antibody than those receiving 10, 20 and 40 micrograms/ml doses (p < 0.05 in all cases). Individuals homozygous for HLA-DRB1*0701; DQB1*0202 failed to produce > 100 IU/l of anti-HBs antibody, whereas, heterozygous individuals required > 10 micrograms/ml Hepagene vaccine. The T-cell responses to Hepagene were exclusive of the dose and magnitude of anti-HBs antibody responses. There was a trend towards increased stimulation indices in those individuals who received repeated 'S' containing vaccines. We have clearly shown that the immune response to Hepagene is influenced by the HLA genotype of the individual. However, further investigation is required to determine the specific role of these molecules in hepatitis B vaccine nonresponse. Hepagene is a registered trademark of Hedeva Pharma Ltd.

Adult↗
PubMed1999

Imported tropical respiratory tract infections.

As the trends in travel continue to rise, travelers are exposed increasingly to a variety of infectious diseases, either by virtue of their chosen geographic destination or as a result of underlying immunosuppressive disease. Little has been published regarding imported tropical respiratory diseases. This article, however, reviews the incidence of respiratory disease both by destination and by travel-related risk groups and factors.

Disease Transmission, Infectious↗
PubMed1998

Hepatitis B third-generation vaccines: improved response and conventional vaccine non-response--evidence for genetic basis in humans.

The lack of response to hepatitis B vaccination remains a problem for those individuals directly at risk of hepatitis B infection, particularly those who work in the health care industry. The factors associated with non-response to hepatitis B vaccination have been investigated in 86 non-responder health care workers who had received multiple 'S' vaccinations without sustained production of anti-HBs. This group received a recently developed hepatitis B vaccine, Hepagene, which included proteins derived from the envelope region of HBV, not present in currently licensed vaccines. The pre-S1 and pre-S2 proteins were included in Hepagene in order to circumvent anti-HBs non-responsiveness which had previously been demonstrated in the inbred mouse model. The inclusion of these additional proteins in Hepagene enabled some seroconverion, from non-responder to responder; however, a proportion of the vaccinees remained non-responders and the reasons for this have been investigated here, with reference to HLA alleles and the demographic predisposition. Here the mechanisms that underlie hepatitis B vaccine non-response have considered the distribution of HLA alleles, age, sex, height and weight in addition to the T-cell responses to Hepagene derived antigens.

Adult↗
PubMed1998

Hepatitis B third-generation vaccines: improved response and conventional vaccine non-response--third generation pre-S/S vaccines overcome non-response.

A new triple-S containing recombinant hepatitis B vaccine was evaluated in terms of immunogenicity and reactogenicity in a cohort of healthy healthcare professionals who were persistent non-responders to the currently licensed hepatitis B vaccines. One hundred subjects were allocated randomly to receive two doses of 5, 10, 20 or 40 micrograms of a new hepatitis B vaccine 2 months apart. The overall seroconversion rate was 70% with a single dose of 20 micrograms of the vaccine being as effective as two doses of either 20 micrograms or 40 micrograms of the vaccine formulation in terms of seroconversion, seroprotection and geometric mean titres.

Cohort Studies↗
PubMed1998

Immunogenicity and reactogenicity of Avaxim (160 AU) as compared with Havrix (1440 EL.U) as a booster following primary immunization with Havrix (1440 EL.U) against hepatitis A.

BACKGROUND: Hepatitis A vaccination is recommended for travelers from the UK to areas of moderate or high endemicity. Two licensed hepatitis A vaccines are now available in the UK, and this trial was undertaken to determine whether Avaxim can be used as a booster following a primary course of Havrix. METHODS: One hundred and eighty-five subjects were randomized to receive a booster dose of either Avaxim (n=92) or Havrix (n=93), 6 to 7 months after a primary dose of Havrix. Subjects were observed for 30 minutes for immediate reactions and subsequently completed a diary card for a further 2 weeks. Serology samples for HAV antibody titers were taken at 28 6 7 days later. RESULTS: One month following the booster dose, all subjects in both treatment groups achieved HAV antibody titers >= 20 mIU/mL. In the Avaxim group, geometric mean titer (GMT) values increased from 642 mIU/mL (97.5% CI 330-1250 mIU/mL) to 6669 mIU/mL (4566-9740 miu/mL), compared with 739 mIU/mL (379-1443 mIU/mL) at baseline to 4460 mIU/mL (2880-6908 mIU/mL) following the administration of Havrix. The increase in GMT following the administration of Avaxim was significantly greater than that following Havrix (p=.02). Eight percent of subjects reported pain at the injection site following a booster dose of Havrix, compared with none following Avaxim. This difference in reactogenicity was statistically significant (p=.01). In all other respects, both preparations were safe and equally well tolerated. CONCLUSION: Either Avaxim or Havrix may be given as a booster dose of hepatitis A vaccine when Havrix has been administered as the primary dose.

Adolescent↗