Randomised Placebo-Controlled Trial of Hepatitis B Surface Antigen Vaccine in French Haemodialysis Units: I, Medical Staff

Crosnier, J; Jungers, Paul; Couroucé, Anne‐Marie; Laplanche, Agnès; Benhamou, E; Degos, Françoise; Lacour, Bernard; Prunet, P; Cerisier, Y.; Guesry, Pierre

doi:10.1016/s0140-6736(81)91847-x

Cited by 156 publications

(56 citation statements)

References 5 publications

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“…The detection of differences in genetic regulation could be facilitated, since it is well known that antibody responses are regulated on the single epitope level. As a consequence, compared with other studies [2,5,10,12,21], we observe a relatively high percentage (19%) of non-and low-responders and their immune system is now being studied.…”

Section: Discussionmentioning

confidence: 51%

“…This is of practical importance in view of revaccination policy, since the initial anti-HBs titer was shown to predict the loss of protection after between 1 and 5 years [11]. As far as the seroconversion rates after the third injection are concerned, there is no difference between the experimental vaccine and the commercially available ones [2,4,23].…”

Section: Discussionmentioning

confidence: 99%

“…The studies of Szmuness et al [21,22], Maupas et al [12], Crosnier et al [2,3], and ReerinkBrongers et al [18] demonstrated the safety and efficacy of active immunization against hepatitis B in homosexuals, children in Senegal, hemodialysis unit staff and patients, and volunteers. These populations are not only at high risk as far as morbidity and mortality of the acute illness is concerned, but also because of chronic viral hepatitis, liver cirrhosis, and primary liver cell carcinomaconditions which to date cannot be treated effectively.…”

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confidence: 99%

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German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

et al. 1986

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Summary.Of the medical staff of our hospital 217 members at high risk for hepatitis B were immunized with an experimental hepatitis B vaccine and anti-HBs titers used to study the influence of two dosage schedules, age, and sex on immunogenicity. Participants were 34 years of age (mean; range, 20-61); they were divided into two groups and vaccinated three times. Group A received 42 lag HBsAg for each vaccination. Group B received 84 lag for the first and 21 lag for the second and third vaccinations. The seroconversion rate was 32.7% after the first, 78.8% after the second, and 95.7% after the third vaccination. The participants who failed to produce anti-HBs titer (3 IU/1; n = 9) or whose anti-HBs titers were below 50 IU/1 (n= 31) were vaccinated a fourth time. Only mild side effects of injections were observed in a third of all participants, usually in the form of a sore arm.Between groups A and B there were no significant differences as far as the seroconversion rate and anti-HBs titer were concerned. Nonresponders plus low-responders accounted for 19%. Female participants produced a markedly higher anti-HBs titer than males, and the female/male ratio among non-and low-responders was 1:2; among nonresponders, 1:2.5. There was a negative correlation of the anti-HBs titer with the age of the participants. These results not only have practical consequences for revaccination policy, but also offer the opportunity to further study the genetic regulation Abbreviations: anti-HBc = antibody to hepatitis B core antigen ; anti-HBe= antibody to hepatitis B e antigen; anti-HBs =anti-body to hepatitis B surface antigen; HBsAg=hepatitis B surface antigen; IU/1 = international units per liter; MSD = Merck, Sharp, and Dohme of the immune response to a complex peptide antigen in man.

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Section: Discussionmentioning

confidence: 51%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

et al. 1986

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“…Up to now the only available vaccine consists of HBsAg 22 nm particles purified from sera of HBV chronic carriers (Szmuness et al, 1980;Crosnier et al, 1981). Recombinant DNA technology is therefore an attractive alternative to produce HBsAg material for vaccine purposes.…”

Section: Discussionmentioning

confidence: 99%

Secretion of the hepatitis B virus surface antigen from mouse cells using an extra-chromosomal eucaryotic vector.

Stenlund¹,

Lamy²,

Moreno‐López³

et al. 1983

The EMBO Journal

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Recombinant DNA molecules which contained a subgenomic fragment of the hepatitis B virus (HBV) genome, the pML2 vector and the bovine papillomavirus type 1 (BPV) genome were constructed. The HBV fragment includes the entire transcription unit for the hepatitis B surface antigen (HBsAg). After propagation in Escherichia coli, the recombinant plasmids were cleaved with endonucleases SalI and PvuI to eliminate most of the bacterial sequences before transfection of mouse C127 cells. Foci were observed 10–14 days after transfection. Cells from selected foci were cloned and the supernatants were assayed for the presence of HBsAg. Most of the clones tested were found to secrete HBsAg particles into the growth medium. These particles appear to be similar to the 22 nm particles present in the serum of HBV chronic carriers. SDS‐polyacrylamide gel electrophoresis revealed that the particles contain two polypeptides, probably representing the glycosylated and unglycosylated forms of the HBsAg major polypeptide. An analysis of DNA from the transformed clones revealed that they contain multiple extra‐chromosomal copies of the recombinant, which, however, had suffered rearrangement.

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“…7 and elevated levels of transaminases among healthy, presumed immuno-•O competent vaccine recipients who had * developed an o p t i m a l a n t i b o d y 4^ response (ie, >10 S/N units by radioimmunoassay) to the surface antigen 1 (anti-HBJ. [1][2][3][4][5][6][7] However, data from follow-up of vaccinated h o m o s e x u a l males have revealed that HB s Ag developed and transaminases became * elevated in some whose maximum H postvaccination anti-HB s response was * s u b o p t i m a l (ie, 2.1 to < 1 0 S/N units). 7 …”

mentioning

confidence: 99%

Hepatitis B Infection in a Vaccinated Renal Dialysis Staff Worker

et al. 1986

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Randomised Placebo-Controlled Trial of Hepatitis B Surface Antigen Vaccine in French Haemodialysis Units: I, Medical Staff

Cited by 156 publications

References 5 publications

German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

Secretion of the hepatitis B virus surface antigen from mouse cells using an extra-chromosomal eucaryotic vector.

Hepatitis B Infection in a Vaccinated Renal Dialysis Staff Worker

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