EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF: Double-blind Placebo-controlled Trial
The efficacy of a heat-inactivated hepatitis B vaccine, 3 μg of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in the con...
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Veröffentlicht in: | The Lancet (British edition) 1983-12, Vol.322 (8363), p.1323-1328 |
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creator | Desmyter, J. De Groote, G. Colaert, J. Reynders, M. Reerink-Brongers, E.E. Dees, P.J. Lelie, P.N. Reesink, H.W. |
description | The efficacy of a heat-inactivated hepatitis B vaccine, 3 μg of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (p= 0·00016), and 94% against HBsAg-positive hepatitis more than 3 months after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomised staff members receiving three monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (p=0·022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the fourth injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the four-dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects. |
doi_str_mv | 10.1016/S0140-6736(83)91089-9 |
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The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (p= 0·00016), and 94% against HBsAg-positive hepatitis more than 3 months after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomised staff members receiving three monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (p=0·022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the fourth injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the four-dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(83)91089-9</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Dialysis ; Effectiveness ; Emergency and intensive care: renal failure. Dialysis management ; Hemodialysis ; Hepatitis ; Hepatitis B ; Hepatitis B surface antigen ; Infections ; Intensive care medicine ; Medical sciences ; Patients ; Randomization ; Side effects ; Vaccines ; Viruses</subject><ispartof>The Lancet (British edition), 1983-12, Vol.322 (8363), p.1323-1328</ispartof><rights>1983</rights><rights>1984 INIST-CNRS</rights><rights>Copyright Elsevier Limited Dec 10, 1983</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0140-6736(83)91089-9$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=9437829$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Desmyter, J.</creatorcontrib><creatorcontrib>De Groote, G.</creatorcontrib><creatorcontrib>Colaert, J.</creatorcontrib><creatorcontrib>Reynders, M.</creatorcontrib><creatorcontrib>Reerink-Brongers, E.E.</creatorcontrib><creatorcontrib>Dees, P.J.</creatorcontrib><creatorcontrib>Lelie, P.N.</creatorcontrib><creatorcontrib>Reesink, H.W.</creatorcontrib><creatorcontrib>The Leuven Renal Transplantation Collaborative Group</creatorcontrib><title>EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF: Double-blind Placebo-controlled Trial</title><title>The Lancet (British edition)</title><description>The efficacy of a heat-inactivated hepatitis B vaccine, 3 μg of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (p= 0·00016), and 94% against HBsAg-positive hepatitis more than 3 months after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomised staff members receiving three monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (p=0·022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the fourth injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the four-dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects.</description><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Dialysis</subject><subject>Effectiveness</subject><subject>Emergency and intensive care: renal failure. Dialysis management</subject><subject>Hemodialysis</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B surface antigen</subject><subject>Infections</subject><subject>Intensive care medicine</subject><subject>Medical sciences</subject><subject>Patients</subject><subject>Randomization</subject><subject>Side effects</subject><subject>Vaccines</subject><subject>Viruses</subject><issn>0140-6736</issn><issn>1474-547X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1983</creationdate><recordtype>article</recordtype><recordid>eNo9kcFq3DAQhkVpoNukj1AQJIf2oESyZFvKpaheO2vYeANWQ3MSWnkMDo6dyruFkJePNwk5Dcx8zPzMh9B3Rs8ZZclFTZmgJEl58kPyn4pRqYj6hBZMpILEIv37GS0-kC_o6zTdU0pFQuMFes6Losx0doc3BV7l2pCy0pkpb7XJl3PjRpvSlDX-jW91lpVVjssKr3R-vVmWen1Xz6MDklemxrpa4troorjEy3G_7YFs-25o8E3vPGxH4sdhF8a-hwab0Ln-BB21rp_g23s9Rn-K3GQrst5czZnWBJhkO9I61TrWyKaRwvGItxyo8pRuuWA09lHUQAxJlECceumpYwAcPDiR0kRJHvNjdPq29zGM__Yw7ez9uA_DfNJGjMs4ZSI-UGfvlJu869vgBt9N9jF0Dy48WSV4KiM1Y7_eMJgT_-8g2Ml3MHhougB-Z5uxs4zagxj7KsYevm4lt69irOIvT5l6Kw</recordid><startdate>19831210</startdate><enddate>19831210</enddate><creator>Desmyter, J.</creator><creator>De Groote, G.</creator><creator>Colaert, J.</creator><creator>Reynders, M.</creator><creator>Reerink-Brongers, E.E.</creator><creator>Dees, P.J.</creator><creator>Lelie, P.N.</creator><creator>Reesink, H.W.</creator><general>Elsevier Ltd</general><general>Lancet</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>ASE</scope><scope>C1K</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>KB~</scope><scope>M7N</scope><scope>NAPCQ</scope></search><sort><creationdate>19831210</creationdate><title>EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF: Double-blind Placebo-controlled Trial</title><author>Desmyter, J. ; De Groote, G. ; Colaert, J. ; Reynders, M. ; Reerink-Brongers, E.E. ; Dees, P.J. ; Lelie, P.N. ; Reesink, H.W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-e181t-fa9fa1d8dd84a323f3e09c00b34105c22de5e626e57c8c0a1ee3ecea470698353</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1983</creationdate><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Dialysis</topic><topic>Effectiveness</topic><topic>Emergency and intensive care: renal failure. Dialysis management</topic><topic>Hemodialysis</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Hepatitis B surface antigen</topic><topic>Infections</topic><topic>Intensive care medicine</topic><topic>Medical sciences</topic><topic>Patients</topic><topic>Randomization</topic><topic>Side effects</topic><topic>Vaccines</topic><topic>Viruses</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Desmyter, J.</creatorcontrib><creatorcontrib>De Groote, G.</creatorcontrib><creatorcontrib>Colaert, J.</creatorcontrib><creatorcontrib>Reynders, M.</creatorcontrib><creatorcontrib>Reerink-Brongers, E.E.</creatorcontrib><creatorcontrib>Dees, P.J.</creatorcontrib><creatorcontrib>Lelie, P.N.</creatorcontrib><creatorcontrib>Reesink, H.W.</creatorcontrib><creatorcontrib>The Leuven Renal Transplantation Collaborative Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>British Nursing Index</collection><collection>Environmental Sciences and Pollution Management</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Newsstand Professional</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Desmyter, J.</au><au>De Groote, G.</au><au>Colaert, J.</au><au>Reynders, M.</au><au>Reerink-Brongers, E.E.</au><au>Dees, P.J.</au><au>Lelie, P.N.</au><au>Reesink, H.W.</au><aucorp>The Leuven Renal Transplantation Collaborative Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF: Double-blind Placebo-controlled Trial</atitle><jtitle>The Lancet (British edition)</jtitle><date>1983-12-10</date><risdate>1983</risdate><volume>322</volume><issue>8363</issue><spage>1323</spage><epage>1328</epage><pages>1323-1328</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>The efficacy of a heat-inactivated hepatitis B vaccine, 3 μg of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (p= 0·00016), and 94% against HBsAg-positive hepatitis more than 3 months after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomised staff members receiving three monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (p=0·022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the fourth injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the four-dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects.</abstract><cop>London</cop><pub>Elsevier Ltd</pub><doi>10.1016/S0140-6736(83)91089-9</doi><tpages>6</tpages></addata></record> |
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subjects | Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Dialysis Effectiveness Emergency and intensive care: renal failure. Dialysis management Hemodialysis Hepatitis Hepatitis B Hepatitis B surface antigen Infections Intensive care medicine Medical sciences Patients Randomization Side effects Vaccines Viruses |
title | EFFICACY OF HEAT-INACTIVATED HEPATITIS B VACCINE IN HAEMODIALYSIS PATIENTS AND STAFF: Double-blind Placebo-controlled Trial |
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