Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): A multicentre, open-label, randomised controlled trial

The Lancet Infectious Diseases

Volumn 15, Issue 11, 2015, Pages 1283-1291

  Rey, David ^a   Piroth, Lionel ^b   Wendling, Marie Josée ^a   Miailhes, Patrick ^c   Michel, Marie Louise ^d   Dufour, Cécilie ^e   Haour, Georges ^e   Sogni, Philippe ^g   Rohel, Alexandra ^h   Ajana, Faiza ⁱ   Billaud, Eric ^j   Molina, Jean Michel ^k   Launay, Odile ^l   Carrat, Fabrice ^e,f,m   Aumaitre, Hugues ⁿ   Berger, Jean Luc ^o   Devidas, Alain ^p   Abgrall, Sophie ^q   Patey, Olivier ^r   Thiebaut, Marie Christine Drobacheff ^s   Lucht, Frédéric ^t   Hoen, Bruno ^s   Lascoux Combe, Caroline ^k   Lortholary, Olivier ^u   Delcey, Véronique ^v   Truchis, Pierre De ^w   Jeantils, Vincent ^x   Vittecoq, Daniel ^y   Slama, Laurence ^z   Zucman, David ^aa   Levy, Yves ^ab   Katlama, Christine ^ac   Simon, Anne ^ac   Girard, Pierre Marie ^ad   Pierre Francois, Sandrine ^ae   Chennebault, Jean Marie ^af   Le Berre, Rozenn ^ag   Neau, Didier ^ah   Livrozet, Jean Michel ^ai   Poizot Martin, Isabelle ^aj   Matheron, Sophie ^ak   Reynes, Jacques ^al   Perre, Philippe ^am   Durand, Jacques ^an   Rosenthal, éric ^an   Arvieux, Cédric ^ao   Cuzin, Lize ^ap   Verdon, Renaud ^aq   Leclercq, Pascale ^ar   May, Thierry ^as   Debab, Yasmine ^at   Lefort, Agnès ^au   Delacroix, Isabelle ^av   Beck Wirth, Geneviève ^aw   Poinsignon, Yves ^ax   Prazuck, Thierry ^ay   Philibert, Patrick ^az   Viard, Jean Paul ^ba   more..

^a UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^b UNIV BOURGOGNE FRANCHE COMTÉ   (France)

^c CROIX ROUSSE HOSPITAL   (France)

^d INSTITUT PASTEUR   (France)

^e INSERM   (France)

^f SORBONNE UNIVERSITÉ   (France)

^g Agence Nationale De Recherche Sur Le Sida Et Les Hépatites ^*  (France)

^h Unit for Basic and Clinical Research on Viral Hepatitis   (France)

ⁱ Hôpital Gustave Dron   (France)

^j NANTES UNIVERSITY HOSPITAL   (France)

^k SAINT LOUIS HOSPITAL   (France)

^l UNIVERSITÉ PARIS DESCARTES   (France)

^m ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

ⁿ Centre Hospitalier Maréchal Joff re   (France)

^o REIMS UNIVERSITY HOSPITAL   (France)

^p CENTRE HOSPITALIER SUD FRANCILIEN   (France)

^q Centre Hospitalier Universitaire Avicenne   (France)

^r Centre Hospitalier Intercommunal de Villeneuve Saint Georges   (France)

^s UNIVERSITY HOSPITAL OF BESANÇON   (France)

^t UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

^u HÔPITAL NECKER ENFANTS MALADES   (France)

^v HÔPITAL LARIBOISIÈRE   (France)

^w RAYMOND POINCARÉ HOSPITAL   (France)

^x HÔPITAL JEAN VERDIER   (France)

^y Hôpital Tenon ^*  (France)

^z HÔPITAL TENON   (France)

^aa FOCH HOSPITAL   (France)

^ab HENRI MONDOR HOSPITAL   (France)

^ac PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^ad HÔPITAL SAINT ANTOINE   (France)

^ae CENTRE HOSPITALIER UNIVERSITAIRE DE FORT DE FRANCE   (France)

^af ANGERS UNIVERSITY HOSPITAL   (France)

^ag SERVICE DE RHUMATOLOGIE   (France)

^ah HÔPITAL PELLEGRIN   (France)

^ai EDOUARD HERRIOT HOSPITAL   (France)

^aj HÔPITAL SAINTE MARGUERITE   (France)

^ak BICHAT HOSPITAL   (France)

^al GUI DE CHAULIAC HOSPITAL   (France)

^am Centre Hospitalier de Vendée   (France)

^an CENTRE HOSPITALIER UNIVERSITAIRE DE NICE   (France)

^ao RENNES UNIVERSITY HOSPITAL   (France)

^ap TOULOUSE UNIVERSITY HOSPITAL   (France)

^aq CHU CÔTE DE NACRE   (France)

^ar GRENOBLE UNIVERSITY HOSPITAL   (France)

^as UNIVERSITY HOSPITAL OF NANCY   (France)

^at ROUEN UNIVERSITY HOSPITAL   (France)

^au BEAUJON HOSPITAL   (France)

^av CENTRE HOSPITALIER INTERCOMMUNAL DE CRÉTEIL   (France)

^aw Hôpital du Moenchberg   (France)

^ax Centre Hospitalier Bretagne Atlantique   (France)

^ay CENTRE HOSPITALIER RÉGIONAL D ORLÉANS   (France)

^az Européen Hospital   (France)

^ba HÔTEL DIEU   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B SURFACE ANTIBODY; RECOMBINANT HEPATITIS B VACCINE; HEPATITIS B ANTIBODY; HEPATITIS B VACCINE; RECOMBINANT VACCINE;

ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD PRESSURE FLUCTUATION; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DIARRHEA; DRUG DOSE COMPARISON; DRUG SAFETY; EDEMA; ERYTHEMA; FEMALE; HEMATOMA; HEPATITIS B; HERPES ZOSTER OPHTHALMICUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERTENSION; HYPERTRANSAMINASEMIA; IMMUNOGENICITY; INFLAMMATION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; PAIN; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; REVACCINATION; RHINOPHARYNGITIS; TREATMENT RESPONSE; VITAMIN D DEFICIENCY; ADVERSE EFFECTS; BLOOD; CLINICAL TRIAL; FRANCE; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNIZATION; IMMUNOLOGY; MIDDLE AGED; PROCEDURES; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; FEMALE; FRANCE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HIV INFECTIONS; HUMANS; IMMUNIZATION, SECONDARY; MALE; MIDDLE AGED; SINGLE-BLIND METHOD; TREATMENT OUTCOME; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84945444443     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)00220-0     Document Type: Article

References (27)

1. Alberti A, Clumeck N, Collins S, et al. Short statement of the first European Consensus Conference on the treatment of chronic hepatitis B and C in HIV co-infected patients. J Hepatol 2005, 42:615-624.
2. Mast EE, Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part II: immunization of adults. MMWR Recomm Rep 2006, 55:1-33.
3. Konopnicki D, Mocroft A, de Wit S, et al. Hepatitis B and HIV: prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS 2005, 19:593-601.
4. Kellerman SE, Hanson DL, McNaghten AD, Fleming PL Prevalence of chronic hepatitis B and incidence of acute hepatitis B infection in human immunodeficiency virus-infected subjects. J Infect Dis 2003, 188:571-577.
5. Larsen C, Pialoux G, Salmon D, et al. Prevalence of hepatitis C and hepatitis B infection in the HIV-infected population of France, 2004. Euro Surveill 2008, 13:18888.
6. Thio CL, Seaberg EC, Skolasky R, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet 2002, 360:1921-1926.
7. Keet IPM, van Doornum G, Safary A, Coutinho RA Insufficient response to hepatitis B vaccination in HIV-positive homosexual men. AIDS 1992, 6:509-510.
8. Bruguera M, Cremades M, Salinas R, Costa J, Grau M, Sans J Impaired response to recombinant hepatitis B vaccine in HIV-infected persons. J Clin Gastroenterol 1992, 14:27-30.
9. Tayal SC, Sankar KN Impaired response to recombinant hepatitis B vaccine in asymptomatic HIV-infected individuals. AIDS 1994, 8:558-559.
10. Fonseca MO, Pang LW, de Paula Cavalheiro N, Barone AA, Heloisa Lopes M Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose. Vaccine 2005, 23:2902-2908.
11. Lemon SM, Thomas DL Vaccines to prevent viral hepatitis. N Engl J Med 1997, 336:196-204.
12. Rey D, Krantz V, Partisani M, Schmitt MP, et al. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine 2000, 18:1161-1165.
13. Launay O, Van der Vliet D, Rosenberg A, et al. Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1. A randomized controlled trial. JAMA 2011, 305:1432-1440.
14. Poland GA, Jacobson RM Prevention of hepatitis B with the hepatitis vaccine. N Engl J Med 2004, 351:2832-2838.
15. De Vries-Sluijs TEMS, Hansen BE, van Doornum GJJ, et al. A prospective open study of the efficacy of high-dose recombinant hepatitis B rechallenge vaccination in HIV-infected patients. J Infect Dis 2008, 197:292-294.
16. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents AIDSinfo, (June 22, 2015). https://aidsinfo.nih.gov/guidelines/html/4/adult-and-adolescent-oi-prevention-and-treatment-guidelines/344/hbv.
17. Wilkins E, Nelson M, Agarwal K, et al. British HIV Association guidelines for the management of hepatitis viruses in adults infected with HIV 2013. HIV Med 2013, 14(suppl 4):1-71.
18. Flynn PN, Cunningham CK, Rudy B, et al. Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. J AIDS 2011, 56:325-332.
19. Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K Comparison of immunogenicity and safety of four doses and four double doses vs standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One 2013, 8:e80409.
20. Potsch DV, Oliveira ML, Ginuíno C, et al. High rates of serological response to a modified hepatitis B vaccination schedule in HIV-infected adults subjects. Vaccine 2010, 28:1447-1550.
21. Potsch DV, Camacho LAB, Tuboi S, et al. Vaccination against hepatitis B with 4-double doses increases response rates and antibodies titers in HIV-infected adults. Vaccine 2012, 30:5973-5977.
22. Ni JD, Xiong YZ, Wang XJ, Xiu LC Does increased hepatitis B vaccination dose lead to a better immune response in HIV-infected patients than standard dose vaccination: a meta-analysis?. Int J STD AIDS 2013, 24:117-122.
23. Pettit NN, DePestel DD, Malani PN, Riddell J Factors associated with seroconversion after standard dose hepatitis B vaccination and high-dose revaccination among HIV-infected patients. HIV Clin Trials 2010, 11:332-339.
24. Rowley K, Payne B, Schmid M Determinants of response to repeat hepatitis B vaccination in HIV-infected prior non-responders. J Infect 2014, 69:98-99.
25. Cruciani M, Mengoli C, Serpelloni G, et al. Serologic response to hepatitis B vaccine with high dose and increasing number of injections in HIV infected adult patients. Vaccine 2009, 27:17-22.
26. Hadler SC, Francis DP, Maynard JE, et al. Long-term immunogenicity and efficacy of hepatitis B vaccine in homosexual men. N Engl J Med 1986, 315:209-214.
27. Wainwright RB, McMahon BJ, Bulkow LR, Parkinson AJ, Harpster AP Protection provided by hepatitis vaccine in a Yupik Eskimo population. Seven-year results. Arch Intern Med 1991, 151:1634-1636.