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3. 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

Author

Eric Billaud, Marie-Josée Wendling, Georges Haour, Fabrice Carrat, Philippe Sogni, Lionel Piroth, Patrick Miailhes, David Rey, Faiza Ajana, Alexandra Rohel, Jean-Michel Molina, Cécilie Dufour, Marie-Louise Michel, Odile Launay, Le Trait d'Union, centre de soins de l'infection par le VIH [CHU Strasbourg], CHU Strasbourg, Département d'infectiologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Laboratoire de Virologie [Strasbourg], Service de Maladies Infectieuses et Tropicales [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Pathogenèse des Virus de l'Hépatite B (PVHB), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Service d'hépatologie médicale [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), ANRS France Recherche Nord & sud Sida-hiv hépatites, Service des Maladies Infectieuses et Tropicales [Hôpital Gustave Dron, Tourcoing], Centre Hospitalier Gustave Dron [Tourcoing], Service des maladies infectieuses et tropicales [CHU Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes), Service des Maladies Infectieuses et Tropicales [CHU Saint Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], CIC Cochin Pasteur (CIC 1417), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe hospitalier Broca-Université Paris Descartes - Paris 5 (UPD5)-Hôtel-Dieu-Hôpital Cochin [AP-HP], Département de santé publique [AP-HP Groupe Hospitalier Est Parisien], Hôpitaux universitaires Est parisien [AP-HP], French National Institute for Medical Research (Inserm)., French National Agency for Research on AIDS and Viral Hepatitis (ANRS)., ANRS HB04 B-BOOST study group : Aumaitre H, Berger JL, Devidas A, Abgrall S, Patey O, Thiebaut MC, Lucht F, Hoen B, Lascoux-Combe C, Lortholary O, Delcey V, De Truchis P, Jeantils V, Vittecoq D, Slama L, Zucman D, Levy Y, Katlama C, Simon A, Girard PM, Molina JM, Pierre-Francois S, Chennebault JM, Le Berre R, Neau D, Livrozet JM, Poizot-Martin I, Matheron S, Reynes J, Billaud É, Perre P, Durand J, Rosenthal É, Arvieux C, Cuzin L, Verdon R, Leclercq P, Ajana F, May T, Debab Y, Lefort A, Delacroix I, Beck-Wirth G, Poinsignon Y, Prazuck T, Philibert P, Viard JP, Andrieu M, Rey D, Carrat F, Launay O, Piroth L, Miailhes P, Ajana F, Sogni P, Michel ML, Wendling MJ, Rohel A, Dufour C, Bailly F, Hanslik T, Touze E, Pol S, Aboulker JP, Chaix ML, Gougeon ML, Allain L, Kaabeche K, Simony M, Rohel A, Metro A, Diallo A, Mendy Y, Paul C, Carrat F, van der Vliet D, Martin K, Pouget N, Dorival C, Dufour C, Rabiéga P, Bendriss R, Lutton O, Duflos Y, N'Diaye A, Boinet S, Toubiwou E, Madouni A, Kutala C, Chevallot C, Goderel I, Pourteau V, Quimbert S, Pannetier G, Bitchiné S, Sallé AV, Chau F., Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Université Paris Descartes - Paris 5 (UPD5)-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM), and Lissalde, Claire

Subjects
Male, Pediatrics, efficacy, HIV Infections, Booster dose, law.invention, 0302 clinical medicine, Randomized controlled trial, law, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, vaccine, Single-Blind Method, 030212 general & internal medicine, Vaccines, Synthetic, 0303 health sciences, number, infected patient, Middle Aged, Hepatitis B, 3. Good health, Vaccination, Treatment Outcome, Infectious Diseases, homosexual man, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, France, Viral hepatitis, Adult, medicine.medical_specialty, Hepatitis B vaccine, Immunization, Secondary, virus, Young Adult, 03 medical and health sciences, medicine, Humans, Hepatitis B Vaccines, Hepatitis B Antibodies, Aged, Intention-to-treat analysis, 030306 microbiology, business.industry, medicine.disease, rate, Regimen, injection, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, impaired response
Abstract

Equipe CHU UB (EA) Pôle MERS CT3 Hors Enjeu ANRS HB04 B-BOOST study group : Hugues Aumaitre (Centre Hospitalier Marechal Joff re, Perpignan, France); Jean-Luc Berger (Centre Hospitalier Universitaire de Reims– Hopital Robert Debre, Reims, France); Alain Devidas (Hopital Gilles de Corbeil–Centre Hospitalier Sud Francilien, Corbeil Essonne, France); Sophie Abgrall (Centre Hospitalier Universitaire Avicenne, Avicenne, France); Olivier Patey (Centre Hospitalier Intercommunal de Villeneuve St Georges, Villeneuve Saint Georges, France); Marie-Christine Drobacheff Thiebaut (Centre Hospitalier Universitaire de Besancon–Hopital Saint Jacques, Besancon, France); Frederic Lucht (Centre Hospitalier Universitaire de St Etienne–Hopital Nord, Saint Etienne, France); Bruno Hoen (Centre Hospitalier Universitaire de Besancon–Hopital Saint Jacques, Besancon, France); Caroline Lascoux-Combe (Hopital Saint Louis, Paris, France); Olivier Lortholary (Hopital Necker, Paris, France); Veronique Delcey (Hopital Lariboisiere, Paris, France); Pierre De Truchis (Hopital Raymond–Poincare, Garches, France); Vincent Jeantils (Hopital Jean Verdier, Bondy, France); Daniel Vittecoq (Le Kremlin Bicetre, France); Laurence Slama (Hopital Tenon, Paris, France); David Zucman (Hopital Foch, Suresnes, France); Yves Levy (Hopital Henri Mondor, Creteil, France); Christine Katlama (Hopital Pitie Salpetriere, Paris, France); Anne Simon (Hopital Pitie Salpetriere, Paris, France); Pierre-Marie Girard (Hopital Saint Antoine, Paris, France); Jean-Michel Molina (CISIH, Hopital Saint Louis, Paris, France); Sandrine Pierre-Francois (Centre Hospitalier Universitaire de Fort de France–Hopital Pierre Zobda Quitman, Fort de France, France); Jean-Marie Chennebault (Centre Hospitalier Universitaire d’Angers–Hopital de l’Hotel Dieu, Angers, France); Rozenn Le Berre (Centre Hospitalier Universitaire de Brest– Hopital de La Cavale Blanche, Brest, France); Didier Neau (Hopital Pellegrin, Bordeaux, France); Jean Michel Livrozet (Hopital Edouard Herriot, Lyon, France); Isabelle Poizot-Martin (Hopital Sainte Marguerite, Marseille, France); Sophie Matheron (Hopital Bichat, Paris, France); Jacques Reynes (Hopital Gui De Chauliac, Montpellier, France); Eric Billaud (Centre Hospitalier Universitaire de Nantes–Hotel Dieu, Nantes, France); Philippe Perre (Centre Hospitalier Departemental de Vendee–Les Oudairies, La Roche sur Yon, France); Jacques Durand (Centre Hospitalier Universitaire de Nice–Hopital de l’Archet, Nice, France); Eric Rosenthal (Centre Hospitalier Universitaire de Nice–Hopital de l’Archet, Nice, France); Cedric Arvieux (Centre Hospitalier Universitaire de Rennes–Hopital Pontchaillou, Rennes, France); Lize Cuzin (Centre Hospitalier Universitaire de Toulouse–Hopital Purpan, Toulouse, France); Renaud Verdon (Centre Hospitalier Universitaire Cote de Nacre, Caen, France); Pascale Leclercq (Centre Hospitalier Universitaire de Grenoble–Hopital Albert Michallon, Grenoble, France); Faiza Ajana (Hopital Gustave Dron, Tourcoing, France); Thierry May (Centre Hospitalier Universitaire Nancy–Hopital Brabois, Nancy, France); Yasmine Debab (Centre Hospitalier Universitaire de Rouen–Hopital Charles Nicolle, Rouen, France); Agnes Lefort (Hopital Beaujon, Clichy, France); Isabelle Delacroix (Centre Hospitalier Intercommunal de Creteil, Creteil, France); Genevieve Beck-Wirth (Hopital du Moenchberg, Mulhouse, France); Yves Poinsignon (Centre Hospitalier Bretagne-Atlantique Vannes, Vannes, France); Thierry Prazuck (Centre Hospitalier Regional–Hopital de La Source, Orleans, France); Patrick Philibert (Hopital Europeen Marseille, Marseille, France); Jean-Paul Viard (Hopital Hotel Dieu, Paris, France).; International audience; BACKGROUND:Revaccination with double-dose hepatitis B vaccine has been recommended in HIV-infected patients who do not respond to standard vaccination, but has not yet been assessed. We aimed to compare the safety and immunogenicity of a reinforced hepatitis B revaccination protocol with the standard revaccination schedule in HIV-infected patients not responding to primary vaccination.METHODS:We did this multicentre, open-label, randomised controlled trial, at 53 centres in France. HIV-infected adults (aged ≥18 years), with CD4 counts of 200 cells per μL or more and no response to a previous hepatitis B vaccination or a 20 μg booster dose, were randomly assigned (1:1), according to a computer-generated randomisation list with permuted blocks (block sizes of two to six), to receive either standard-dose (20 μg) or double-dose (40 μg) recombinant hepatitis B vaccine at weeks 0, 4, and 24. Randomisation was stratified by baseline CD4 count (200-349 vs ≥350 cells per μL). Patients and treating physicians were not masked to treatment allocation, but the randomisation list was concealed from the investigators who assigned participants to the vaccination groups. The primary endpoint was the proportion of responders, defined as patients with hepatitis B surface antibody (anti-HBs) titres of 10 mIU/mL or more, at week 28. We did analysis by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00670839.FINDINGS:Between May 19, 2008, and May 8, 2011, 178 participants were randomly assigned to the standard-dose group (n=90) or the double-dose group (n=88), of whom 176 (98%) participants were included in the primary efficacy analysis. At week 28, we recorded a response in 60 patients (67%, 95% CI 57-77) in the standard-dose group versus 64 patients (74%, 63-82) in the double-dose group (p=0·334). Except for more frequent local reactions in the double-dose group than the standard-dose group (13 [15%] vs four [4%] patients; p=0·020), there was no difference in safety between groups.INTERPRETATION:In adults with HIV-1 who have not responded to previous hepatitis B vaccination, double-dose revaccination did not achieve a higher response rate than did revaccination with standard single-dose regimen. However, the safety profile was similar between treatment groups. Our results should be assessed in future studies before double-dose vaccine can be considered for the standard of care of vaccine non-responders.FUNDING:French National Institute for Medical Research-French National Agency for Research on AIDS and Viral Hepatitis.

Published
2015

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