Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine
To determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis. The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam,...
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| Veröffentlicht in: | AIDS (London) 2010-03, Vol.24 (5), p.675-685 |
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| creator | VON REYN, Charles F MTEI, Lillian HORSBURGH, Charles R PALLANGYO, Kisali ALBEIT, Robert D WADDELL, Richard COLE, Bernard MACKENZIE, Todd MATEE, Mecky BAKARI, Muhammad TVAROHA, Susan ADAMS, Lisa V |
| description | To determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis.
The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/microl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints).
Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events.
Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis. |
| doi_str_mv | 10.1097/QAD.0b013e3283350f1b |
| format | Article |
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The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/microl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints).
Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events.
Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis.</description><identifier>ISSN: 0269-9370</identifier><identifier>EISSN: 1473-5571</identifier><identifier>DOI: 10.1097/QAD.0b013e3283350f1b</identifier><identifier>PMID: 20118767</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Adult ; Bacterial diseases ; BCG Vaccine - immunology ; Biological and medical sciences ; CD4 antigen ; CD4 Lymphocyte Count ; Children ; Clinical trials ; Dose-Response Relationship, Immunologic ; Double-Blind Method ; Female ; HIV Infections - complications ; HIV Infections - epidemiology ; HIV Infections - immunology ; Human bacterial diseases ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunity, Cellular ; Immunization ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Isoniazid ; Male ; Medical sciences ; Mycobacterium ; Mycobacterium vaccae ; Side effects ; Skin tests ; Tanzania - epidemiology ; Tuberculin ; Tuberculosis ; Tuberculosis - epidemiology ; Tuberculosis - immunology ; Tuberculosis - prevention & control ; Tuberculosis and atypical mycobacterial infections ; Vaccines ; Vaccines, Inactivated - immunology ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>AIDS (London), 2010-03, Vol.24 (5), p.675-685</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-b14b4895dd3d0de2adcc17526c3b36d301c3978cb62dd5f36606482a3c97650d3</citedby><cites>FETCH-LOGICAL-c470t-b14b4895dd3d0de2adcc17526c3b36d301c3978cb62dd5f36606482a3c97650d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22592275$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20118767$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>VON REYN, Charles F</creatorcontrib><creatorcontrib>MTEI, Lillian</creatorcontrib><creatorcontrib>HORSBURGH, Charles R</creatorcontrib><creatorcontrib>PALLANGYO, Kisali</creatorcontrib><creatorcontrib>ALBEIT, Robert D</creatorcontrib><creatorcontrib>WADDELL, Richard</creatorcontrib><creatorcontrib>COLE, Bernard</creatorcontrib><creatorcontrib>MACKENZIE, Todd</creatorcontrib><creatorcontrib>MATEE, Mecky</creatorcontrib><creatorcontrib>BAKARI, Muhammad</creatorcontrib><creatorcontrib>TVAROHA, Susan</creatorcontrib><creatorcontrib>ADAMS, Lisa V</creatorcontrib><creatorcontrib>DarDar Study Group</creatorcontrib><title>Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine</title><title>AIDS (London)</title><addtitle>AIDS</addtitle><description>To determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis.
The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/microl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints).
Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events.
Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis.</description><subject>Adult</subject><subject>Bacterial diseases</subject><subject>BCG Vaccine - immunology</subject><subject>Biological and medical sciences</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Dose-Response Relationship, Immunologic</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - epidemiology</subject><subject>HIV Infections - immunology</subject><subject>Human bacterial diseases</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunity, Cellular</subject><subject>Immunization</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Isoniazid</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mycobacterium</subject><subject>Mycobacterium vaccae</subject><subject>Side effects</subject><subject>Skin tests</subject><subject>Tanzania - epidemiology</subject><subject>Tuberculin</subject><subject>Tuberculosis</subject><subject>Tuberculosis - epidemiology</subject><subject>Tuberculosis - immunology</subject><subject>Tuberculosis - prevention & control</subject><subject>Tuberculosis and atypical mycobacterial infections</subject><subject>Vaccines</subject><subject>Vaccines, Inactivated - immunology</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0269-9370</issn><issn>1473-5571</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1uFDEQhS1ERIbADRDyBrGhg3_advcKhQGSSJEACdha_mvGyGMntntQTsE5OAcXw5NMEmDDquSqr5786gHwBKNDjEbx8uPRm0OkEaaOkoFShias74EF7gXtGBP4PlggwsdupALtg4elfEMIMTQMD8A-QRgPgosF-PEhu42L1acI0wTrrF02c0jFF-gjfK2MD8HBpQprV6vrjudfP7OP3Xn2a2dfwJPTL52PkzPVWajsHGqBOqWyfX73dQVVbDrKVL9RV71VCq4zLgS4vjRJt4nLXgW4Ucb46B6BvUmF4h7v6gH4_O7tp-VJd_b--HR5dNaZXqDaadzrfhiZtdQi64iyxmDBCDdUU24pwoaOYjCaE2vZRDlHvB-IomYUnCFLD8Cra93zWTcjpp0gqyC3tlS-lEl5-fck-pX8mjYSI0YY6nFTeL5TyOlidqXKtS9bYyq6NBcp-p4L3G7-f5JSTpot2sj-mjQ5lZLddPshjOQ2ddlSl_-m3tae_mnmdukm5gY82wGqGBWmrKLx5Y4jbCREMPobqW26Ng</recordid><startdate>20100313</startdate><enddate>20100313</enddate><creator>VON REYN, Charles F</creator><creator>MTEI, Lillian</creator><creator>HORSBURGH, Charles R</creator><creator>PALLANGYO, Kisali</creator><creator>ALBEIT, Robert D</creator><creator>WADDELL, Richard</creator><creator>COLE, Bernard</creator><creator>MACKENZIE, Todd</creator><creator>MATEE, Mecky</creator><creator>BAKARI, Muhammad</creator><creator>TVAROHA, Susan</creator><creator>ADAMS, Lisa V</creator><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7QL</scope><scope>7T5</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>20100313</creationdate><title>Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine</title><author>VON REYN, Charles F ; MTEI, Lillian ; HORSBURGH, Charles R ; PALLANGYO, Kisali ; ALBEIT, Robert D ; WADDELL, Richard ; COLE, Bernard ; MACKENZIE, Todd ; MATEE, Mecky ; BAKARI, Muhammad ; TVAROHA, Susan ; ADAMS, Lisa V</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-b14b4895dd3d0de2adcc17526c3b36d301c3978cb62dd5f36606482a3c97650d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Bacterial diseases</topic><topic>BCG Vaccine - immunology</topic><topic>Biological and medical sciences</topic><topic>CD4 antigen</topic><topic>CD4 Lymphocyte Count</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Dose-Response Relationship, Immunologic</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>HIV Infections - complications</topic><topic>HIV Infections - epidemiology</topic><topic>HIV Infections - immunology</topic><topic>Human bacterial diseases</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunity, Cellular</topic><topic>Immunization</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>Infectious diseases</topic><topic>Isoniazid</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mycobacterium</topic><topic>Mycobacterium vaccae</topic><topic>Side effects</topic><topic>Skin tests</topic><topic>Tanzania - epidemiology</topic><topic>Tuberculin</topic><topic>Tuberculosis</topic><topic>Tuberculosis - epidemiology</topic><topic>Tuberculosis - immunology</topic><topic>Tuberculosis - prevention & control</topic><topic>Tuberculosis and atypical mycobacterial infections</topic><topic>Vaccines</topic><topic>Vaccines, Inactivated - immunology</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>VON REYN, Charles F</creatorcontrib><creatorcontrib>MTEI, Lillian</creatorcontrib><creatorcontrib>HORSBURGH, Charles R</creatorcontrib><creatorcontrib>PALLANGYO, Kisali</creatorcontrib><creatorcontrib>ALBEIT, Robert D</creatorcontrib><creatorcontrib>WADDELL, Richard</creatorcontrib><creatorcontrib>COLE, Bernard</creatorcontrib><creatorcontrib>MACKENZIE, Todd</creatorcontrib><creatorcontrib>MATEE, Mecky</creatorcontrib><creatorcontrib>BAKARI, Muhammad</creatorcontrib><creatorcontrib>TVAROHA, Susan</creatorcontrib><creatorcontrib>ADAMS, Lisa V</creatorcontrib><creatorcontrib>DarDar Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>VON REYN, Charles F</au><au>MTEI, Lillian</au><au>HORSBURGH, Charles R</au><au>PALLANGYO, Kisali</au><au>ALBEIT, Robert D</au><au>WADDELL, Richard</au><au>COLE, Bernard</au><au>MACKENZIE, Todd</au><au>MATEE, Mecky</au><au>BAKARI, Muhammad</au><au>TVAROHA, Susan</au><au>ADAMS, Lisa V</au><aucorp>DarDar Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine</atitle><jtitle>AIDS (London)</jtitle><addtitle>AIDS</addtitle><date>2010-03-13</date><risdate>2010</risdate><volume>24</volume><issue>5</issue><spage>675</spage><epage>685</epage><pages>675-685</pages><issn>0269-9370</issn><eissn>1473-5571</eissn><abstract>To determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis.
The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/microl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints).
Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events.
Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>20118767</pmid><doi>10.1097/QAD.0b013e3283350f1b</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | AIDS (London), 2010-03, Vol.24 (5), p.675-685 |
| issn | 0269-9370 1473-5571 |
| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Journals@Ovid Complete |
| subjects | Adult Bacterial diseases BCG Vaccine - immunology Biological and medical sciences CD4 antigen CD4 Lymphocyte Count Children Clinical trials Dose-Response Relationship, Immunologic Double-Blind Method Female HIV Infections - complications HIV Infections - epidemiology HIV Infections - immunology Human bacterial diseases Human immunodeficiency virus Human viral diseases Humans Immunity, Cellular Immunization Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology Infectious diseases Isoniazid Male Medical sciences Mycobacterium Mycobacterium vaccae Side effects Skin tests Tanzania - epidemiology Tuberculin Tuberculosis Tuberculosis - epidemiology Tuberculosis - immunology Tuberculosis - prevention & control Tuberculosis and atypical mycobacterial infections Vaccines Vaccines, Inactivated - immunology Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine |
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