Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB): studies in volunteers at a low risk of infection with hepatitis B virus
The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine (CLB) were evaluated in 471 healthy human volunteers, who, both in their occupations and in their private lives, had been at minimal risk of being infected with hepatitis B virus. The first 202 individuals receive...
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| Veröffentlicht in: | American journal of epidemiology 1984-11, Vol.120 (5), p.694-702 |
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| container_title | American journal of epidemiology |
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| creator | LELIE, P. N REESINK, H. W DE JONG-VAN MANEN, S. T DEES, P. J REERINK-BRONGERS, E. E |
| description | The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine (CLB) were evaluated in 471 healthy human volunteers, who, both in their occupations and in their private lives, had been at minimal risk of being infected with hepatitis B virus. The first 202 individuals received three 3-micrograms doses of heat-inactivated hepatitis B surface antigen (HBsAg) at one-month intervals (trial A). A total of 42% one month after the first injection, 84% after two months, and 93% after five months had become anti-HBs (antibody to hepatitis B surface antigen) positive. In a second randomized study (trial B), the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers. When the dose of HBsAg was diminished from 3 micrograms to 1.5, 0.6, and 0.25 microgram, no decrease of the anti-HBs response was observed. However, when the dose was diminished to 0.1 microgram of HBsAg, the anti-HBs response dropped significantly to 63% (p less than 0.001). In the recipients of all five vaccine dosages, no influence of sex and age was found on the anti-HBs conversion rates. During the eight-month observation period, none of the vaccinees became HBsAg and/or anti-HBc (antibody to hepatitis B core antigen) positive, and none developed antibodies associated with autoimmune liver disease. No serious side effects were observed. |
| doi_str_mv | 10.1093/oxfordjournals.aje.a113936 |
| format | Article |
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N ; REESINK, H. W ; DE JONG-VAN MANEN, S. T ; DEES, P. J ; REERINK-BRONGERS, E. E</creator><creatorcontrib>LELIE, P. N ; REESINK, H. W ; DE JONG-VAN MANEN, S. T ; DEES, P. J ; REERINK-BRONGERS, E. E</creatorcontrib><description>The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine (CLB) were evaluated in 471 healthy human volunteers, who, both in their occupations and in their private lives, had been at minimal risk of being infected with hepatitis B virus. The first 202 individuals received three 3-micrograms doses of heat-inactivated hepatitis B surface antigen (HBsAg) at one-month intervals (trial A). A total of 42% one month after the first injection, 84% after two months, and 93% after five months had become anti-HBs (antibody to hepatitis B surface antigen) positive. In a second randomized study (trial B), the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers. When the dose of HBsAg was diminished from 3 micrograms to 1.5, 0.6, and 0.25 microgram, no decrease of the anti-HBs response was observed. However, when the dose was diminished to 0.1 microgram of HBsAg, the anti-HBs response dropped significantly to 63% (p less than 0.001). In the recipients of all five vaccine dosages, no influence of sex and age was found on the anti-HBs conversion rates. During the eight-month observation period, none of the vaccinees became HBsAg and/or anti-HBc (antibody to hepatitis B core antigen) positive, and none developed antibodies associated with autoimmune liver disease. No serious side effects were observed.</description><identifier>ISSN: 0002-9262</identifier><identifier>EISSN: 1476-6256</identifier><identifier>DOI: 10.1093/oxfordjournals.aje.a113936</identifier><identifier>PMID: 6496450</identifier><identifier>CODEN: AJEPAS</identifier><language>eng</language><publisher>Cary, NC: Oxford University Press</publisher><subject>Adult ; Autoantibodies - isolation & purification ; Biological and medical sciences ; Dose-Response Relationship, Immunologic ; Female ; Hepatitis B - immunology ; Hepatitis B Surface Antigens - administration & dosage ; hepatitis B virus ; Human viral diseases ; Humans ; Immunization - methods ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Vaccines - administration & dosage ; Viral diseases ; Viral hepatitis</subject><ispartof>American journal of epidemiology, 1984-11, Vol.120 (5), p.694-702</ispartof><rights>1985 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27867,27922,27923</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=8914088$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/6496450$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LELIE, P. 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A total of 42% one month after the first injection, 84% after two months, and 93% after five months had become anti-HBs (antibody to hepatitis B surface antigen) positive. In a second randomized study (trial B), the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers. When the dose of HBsAg was diminished from 3 micrograms to 1.5, 0.6, and 0.25 microgram, no decrease of the anti-HBs response was observed. However, when the dose was diminished to 0.1 microgram of HBsAg, the anti-HBs response dropped significantly to 63% (p less than 0.001). In the recipients of all five vaccine dosages, no influence of sex and age was found on the anti-HBs conversion rates. During the eight-month observation period, none of the vaccinees became HBsAg and/or anti-HBc (antibody to hepatitis B core antigen) positive, and none developed antibodies associated with autoimmune liver disease. No serious side effects were observed.</description><subject>Adult</subject><subject>Autoantibodies - isolation & purification</subject><subject>Biological and medical sciences</subject><subject>Dose-Response Relationship, Immunologic</subject><subject>Female</subject><subject>Hepatitis B - immunology</subject><subject>Hepatitis B Surface Antigens - administration & dosage</subject><subject>hepatitis B virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunization - methods</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Vaccines - administration & dosage</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0002-9262</issn><issn>1476-6256</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1984</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>K30</sourceid><recordid>eNqFkc9uFDEMxqMKVLaFR6gUAarKYZb8nwk3uipQaSUuva_cTNJmmUmGJLNtH4c3bYAtElw42bJ__mzrQ-g1JUtKNH8f711M_TbOKcCQl7C1S6CUa64O0IKKVjWKSfUMLQghrNFMsRfoKOctIZRqSQ7RoRJaCUkW6MflOM4h3tjgjS8PGEKPMzhb0-gw4GmAPELT2-R3tse3FkrjA5jid1B-FSYovviMz_EOjPHB4rPV-vzdB5zL3HubsQ94F4c5FGtTxlCq6hDvcPL5288dPjhb5WLAd77c_i3o05xfoueufmlf7eMxuvp0cbX60qy_fr5cfVw3E9OiNLrtOSfESM1aTRxrZc-1tBqoaxWj1FAFVraGEieZElwCF0yBJnXqWjp-jE5_y04pfp9tLpvRZ2OHAYKNc950lDOhuu6_YPWhkx2XFXzzD_jkWGWIUqKVglTqZE_N16PtN1PyI6SHzd6h2n-770M2MLgEwfj8B-s0FaRe9QgBpqTP</recordid><startdate>198411</startdate><enddate>198411</enddate><creator>LELIE, P. 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N</au><au>REESINK, H. W</au><au>DE JONG-VAN MANEN, S. T</au><au>DEES, P. J</au><au>REERINK-BRONGERS, E. E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB): studies in volunteers at a low risk of infection with hepatitis B virus</atitle><jtitle>American journal of epidemiology</jtitle><addtitle>Am J Epidemiol</addtitle><date>1984-11</date><risdate>1984</risdate><volume>120</volume><issue>5</issue><spage>694</spage><epage>702</epage><pages>694-702</pages><issn>0002-9262</issn><eissn>1476-6256</eissn><coden>AJEPAS</coden><abstract>The safety and immunogenicity of a plasma-derived heat-inactivated hepatitis B vaccine (CLB) were evaluated in 471 healthy human volunteers, who, both in their occupations and in their private lives, had been at minimal risk of being infected with hepatitis B virus. The first 202 individuals received three 3-micrograms doses of heat-inactivated hepatitis B surface antigen (HBsAg) at one-month intervals (trial A). A total of 42% one month after the first injection, 84% after two months, and 93% after five months had become anti-HBs (antibody to hepatitis B surface antigen) positive. In a second randomized study (trial B), the immunogenicity of five different dosages of the vaccine was compared in 269 volunteers. When the dose of HBsAg was diminished from 3 micrograms to 1.5, 0.6, and 0.25 microgram, no decrease of the anti-HBs response was observed. However, when the dose was diminished to 0.1 microgram of HBsAg, the anti-HBs response dropped significantly to 63% (p less than 0.001). In the recipients of all five vaccine dosages, no influence of sex and age was found on the anti-HBs conversion rates. During the eight-month observation period, none of the vaccinees became HBsAg and/or anti-HBc (antibody to hepatitis B core antigen) positive, and none developed antibodies associated with autoimmune liver disease. No serious side effects were observed.</abstract><cop>Cary, NC</cop><pub>Oxford University Press</pub><pmid>6496450</pmid><doi>10.1093/oxfordjournals.aje.a113936</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-9262 |
| ispartof | American journal of epidemiology, 1984-11, Vol.120 (5), p.694-702 |
| issn | 0002-9262 1476-6256 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals Digital Archive Legacy; Periodicals Index Online |
| subjects | Adult Autoantibodies - isolation & purification Biological and medical sciences Dose-Response Relationship, Immunologic Female Hepatitis B - immunology Hepatitis B Surface Antigens - administration & dosage hepatitis B virus Human viral diseases Humans Immunization - methods Infectious diseases Male Medical sciences Middle Aged Vaccines - administration & dosage Viral diseases Viral hepatitis |
| title | Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB): studies in volunteers at a low risk of infection with hepatitis B virus |
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