Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: A phase I/II, randomized trial

AIDS

Volumn 28, Issue 12, 2014, Pages 1769-1781

  Thacher, Eleonora G ^a   Cavassini, Matthias ^a   Audran, Régine ^a   Thierry, Anne Christine ^a   Bollaerts, Anne ^b   Cohen, Joe ^b   Demoitié, Marie Ange ^b   Ejigu, Dawit ^b   Mettens, Pascal ^b   Moris, Philippe ^b   Ofori Anyinam, Opokua ^b   Spertini, François ^a  

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b GSK   (Belgium)

Author keywords

AS01; HIV positive on antiretroviral therapy,immunogenicity; M72; tuberculosis vaccine

Indexed keywords

BCG VACCINE; CD40 LIGAND; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; GAMMA INTERFERON; INTERLEUKIN 2; LAMIVUDINE PLUS ZIDOVUDINE; M72 AS01; SODIUM CHLORIDE; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; ADJUVANT SYSTEM 01; ANTI-RETROVIRAL AGENTS; ANTIBODIES, BACTERIAL; DRUG COMBINATIONS; IMMUNOGLOBULIN G; LIPID A; PLACEBOS; SAPONINS; TUBERCULOSIS VACCINES;

ADULT; ARTICLE; BCG VACCINATION; CD4 LYMPHOCYTE COUNT; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; HEADACHE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE PRURITUS; LABORATORY TEST; MALE; MEDICAL RECORD; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SWITZERLAND; TUBERCULOSIS; VIREMIA; VIRUS LOAD; ADOLESCENT; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; BLOOD; CD4-POSITIVE T-LYMPHOCYTES; CLINICAL TRIAL; COMPLICATION; DRUG COMBINATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HIV INFECTIONS; HUMANS; IMMUNOLOGY; METHODS; MIDDLE AGED; PATHOLOGY; SINGLE-BLIND METHOD; T-LYMPHOCYTE SUBSETS; TREATMENT OUTCOME; VACCINATION; YOUNG ADULT;

ADOLESCENT; ADULT; ANTI-RETROVIRAL AGENTS; ANTIBODIES, BACTERIAL; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4-POSITIVE T-LYMPHOCYTES; DRUG COMBINATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HIV INFECTIONS; HUMANS; IMMUNOGLOBULIN G; LIPID A; MALE; MIDDLE AGED; PLACEBOS; SAPONINS; SINGLE-BLIND METHOD; SWITZERLAND; T-LYMPHOCYTE SUBSETS; TREATMENT OUTCOME; TUBERCULOSIS; TUBERCULOSIS VACCINES; VACCINATION; YOUNG ADULT;

EID: 84904176496     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000343     Document Type: Article

References (57)

1. Getahun H, Gunneberg C, Granich R, Nunn P. HIV infectionassociated tuberculosis the epidemiology and the response. Clin Infect Dis 2010 50 (Suppl 3)S201-S207.
2. Pawlowski A, Jansson M, Sköld M, Rottenberg ME, Källenius G. Tuberculosis and HIV co-infection. PLoS Pathog 2012 8e1002464.
3. World Health Organization. Global tuberculosis control WHO report 2013. Geneva, Switzerland WHO 2013. WHO/HTM/TB/2013.11. pp. 1-289. URL http//whqlibdoc.who.int/publications/2011/9789241500708-eng.pdf [accessed 16 April 2013].
4. Modjarrad K, Vermund SH. Effect of treating co-infections on HIV-1 viral load a systematic review. Lancet Infect Dis 2010 10455-463.
5. Geldmacher C, Zumla A, Hoelscher M. Interaction between HIV and Mycobacterium tuberculosis HIV-1-induced CD4 T-cell depletion and the development of active tuberculosis. Curr Opin HIV AIDS 2012 7268-275.
6. Sutherland JS, Young JM, Peterson KL, Sanneh B, Whittle HC, Rowland-Jones SL, et al. Polyfunctional CD4Rand CD8RT cell responses to tuberculosis antigens in HIV-1-infected patients before and after antiretroviral treatment. J Immunol 2010 1846537-6544.
7. Glynn JR, Murray J, Bester A, Nelson G, Shearer S, Sonnenberg P. High rates of recurrence in HIV-infected and HIV-uninfected patients with tuberculosis. J Infect Dis 2010 201704-711.
8. Horsburgh CR Jr, O'Donnell M, Chamblee S, Moreland JL, Johnson J, Marsh BJ, et al. Revisiting rates of reactivation tuberculosis a population-based approach. Am J Respir Crit Care Med 2010 182420-425.
9. Aaron L, Saadoun D, Calatroni I, Launay O, Mémain N, Vincent V, et al. Tuberculosis in HIV-infected patients a comprehensive review. Clin Microbiol Infect 2004 10388-398.
10. World Health Organization. Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings.20111-39, See http//whqlibdoc.who.int/ publications/2011/9789241500708-eng.pdf (accessed 16 April 2013).
11. Hermans SM, Kiragga AN, Schaefer P, Kambugu A, Hoepelman AI, Manabe YC. Incident tuberculosis during antiretroviral therapy contributes to suboptimal immune reconstitution in a large urban HIV clinic in sub-Saharan Africa. PLoS One 2010 5e10527.
12. Houben RM, Glynn JR, Mboma S, Mzemba T, Mwaungulu NJ, Mwaungulu L, et al. The impact of HIV and ART on recurrent tuberculosis in a sub-Saharan setting. AIDS 2012 262233-2239.
13. Palacios E, Franke M, Muñoz M, Hurtado R, Dallman R, Chalco K, et al. HIV-positive patients treated for multidrug-resistant tuberculosis clinical outcomes in the HAART era. Int J Tuberc Lung Dis 2012 16348-354.
14. Dheda K, Shean K, Zumla A, Badri M, Streicher EM, Page-Shipp L, et al. Early treatment outcomes and HIV status of patients with extensively drug-resistant tuberculosis in South Africa a retrospective cohort study. Lancet 2010 3751798-1807.
15. North RJ, Jung Y-J. Immunity to tuberculosis. Annu Rev Immunol 2004 22599-623.
16. Lawn SD, Bekker L-G, Wood R. How effectively does HAART restore immune responses to Mycobacterium tuberculosis? Implications for tuberculosis control. AIDS 2005 191113-1124.
17. Gupta A, Wood R, Kaplan R, Bekker L-G, Lawn SD. Tuberculosis incidence rates during 8 years of follow-up of an antiretroviral treatment cohort in South Africa comparison with rates in the community. PLoS One 2012 7e34156.
18. Harries AD, Lawn SD, Getahun H, Zachariah R, Havlir DV. HIV and tuberculosis-science and implementation to turn the tide and reduce deaths. J Int AIDS Soc 2012 1517396.
19. Suthar AB, Lawn SD, Del Amo J, Getahun H, Dye C, Sculier D, et al. Antiretroviral therapy for prevention of tuberculosis in adults with HIV a systematic review and meta-analysis. PLoS Med 2012 9e1001270.
20. Doherty M, Ford N, Vitoria M, Weiler G, Hirnschall G. The 2013 WHO guidelines for antiretroviral therapy evidencebased recommendations to face new epidemic realities. Curr Opin HIV AIDS 2013 8528-534.
21. Tuboi SH, Brinkhof MW, Egger M, Stone RA, Braitstein P, Nash D, et al. Discordant responses to potent antiretroviral treatment in previously naive HIV-1-infected adults initiating treatment in resource-constrained countries the antiretroviral therapy in low-income countries (ART-LINC) collaboration. J Acquir Immune Defic Syndr 2007 4552-59.
22. Gazzola L, Tincati C, Bellistri GM, Monforte A, Marchetti G. The absence of CD4R T cell count recovery despite receipt of virologically suppressive highly active antiretroviral therapy clinical risk, immunological gaps, and therapeutic options. Clin Infect Dis 2009 48328-337.
23. Kernodle DS. Decrease in the effectiveness of Bacille Calmette-Guérin vaccine against pulmonary tuberculosis a consequence of increased immune suppression by microbial antioxidants, not overattenuation. Clin Infect Dis 2010 51177-184.
24. World Health Organization. Revised BCG vaccination guidelines for infants at risk for HIV infection. Wkly Epidemiol Rec 2007 82193-196.
25. Colditz GA, Berkey CS, Mosteller F, Brewer TF, Wilson ME, Burdick E, et al. The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis meta-analyses of the published literature. Pediatrics 1995 9629-35.
26. Orme IM. Vaccine development for tuberculosis current progress. Drugs 2013 731015-1024.
27. von Reyn CF, Bakari M, Arbeit RD, Lahey T, Ramadhani A, Egwaga S. New vaccines for the prevention of tuberculosis in human immunodeficiency virus infection. Int J Tuberc Lung Dis 2012 16718-723.
28. von Reyn CF, Mtei L, Arbeit RD, Waddell R, Cole B, MacKenzie T, et al. Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. AIDS 2010 24675-685.
29. Montoya J, Solon JA, Cunanan SR, Acosta L, Bollaerts A, Moris P, et al. A randomized, controlled dose-finding Phase II study of the M72/AS01 candidate tuberculosis vaccine in healthy PPD-positive adults. J Clin Immunol 2013 331360-1375.
30. Leroux-Roels I, Forgus S, De Boever F, Clement F, Demoitié MA, Mettens P, et al. Improved CD4R T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations a randomized trial. Vaccine 2013 312196-2206.
31. Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, et al. Induction and regulation of T-cell immunity by the novel TB vaccine M72/AS01 in South African adults. Am J Respir Crit Care Med 2013 188492-502.
32. Schoeni-Affolter F, Ledergerber B, Rickenbach M, Rudin C, Günthard HF, Telenti A, et al. Cohort profile the Swiss HIV Cohort study. Int J Epidemiol 2010 391179-1189.
33. Manuel O, Pascual M, Hoschler K, Giulieri S, Alves D, Ellefsen K, et al. Humoral response to the influenza A H1N1/09 monovalent AS03-adjuvanted vaccine in immunocompromised patients. Clin Infect Dis 2011 52248-256.
34. Potsch DV, Camacho LA, Tuboi S, Villar LM, Miguel JC, Ginu?́no C, et al. Vaccination against hepatitis B with 4-double doses increases response rates and antibodies titers in HIVinfected adults. Vaccine 2012 305973-5977.
35. Søgaard OS, Schønheyder HC, Bukh AR, Harboe ZB, Rasmussen TA, østergaard L, et al. Pneumococcal conjugate vaccination in persons with HIV the effect of highly active antiretroviral therapy. AIDS 2010 241315-1322.
36. Elzi L, Schlegel M, Weber R, Hirschel B, Cavassini M, Schmid P, et al. Reducing tuberculosis incidence by tuberculin skin testing, preventive treatment, and antiretroviral therapy in an area of low tuberculosis transmission. Clin Infect Dis 2007 4494-102.
37. Garçon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines concepts, achievements and perspectives. Expert Rev Vaccines 2007 6723-739.
38. Garçon N, Van Mechelen M. Recent clinical experience with vaccines using MPL-and QS-21-containing Adjuvant Systems. Expert Rev Vaccines 2011 10471-486.
39. Moris P, van der Most R, Leroux-Roels I, Clement F, Dramé M, Hanon E, et al. H5N1 influenza vaccine formulated with AS03A induces strong cross-reactive and polyfunctional CD4 T-cell responses. J Clin Immunol 2011 31443-454.
40. Lichterfeld M, Gandhi RT, Simmons RP, Flynn T, Sbrolla A, Yu XG, et al. Induction of strong HIV-1-specific CD4R T-cell responses using an HIV-1 gp120/NefTat vaccine adjuvanted with AS02A in ARV-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr 2012 591-9.
41. Harrer T, Plettenberg A, Arasteh K, Van Lunzen J, Fätkenheuer G, Jaeger H, et al. Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection a randomised placebo-controlled study. Vaccine 2014 322657-2665.
42. Lange CG, Lederman MM, Medvik K, Asaad R, Wild M, Kalayjian R, et al. Nadir CD4R T-cell count and numbers of CD28R CD4R T-cells predict functional responses to immunizations in chronic HIV-1 infection. AIDS 2003 172015-2023.
43. Brandt L, Feino Cunha J, Weinreich Olsen A, Chilima B, Hirsch P, Appelberg R, et al. Failure of the Mycobacterium bovis BCG vaccine some species of environmental mycobacteria block multiplication of BCG and induction of protective immunity to tuberculosis. Infect Immun 2002 70672-678.
44. Rook GA, Dheda K, Zumla A. Immune systems in developed and developing countries implications for the design of vaccines that will work where BCG does not. Tuberculosis (Edinb) 2006 86152-162.
45. Elias D, Wolday D, Akuffo H, Petros B, Bronner U, Britton S. Effect of deworming on human T cell responses to mycobacterial antigens in helminth-exposed individuals before and after bacille Calmette-Guérin (BCG) vaccination. Clin Exp Immunol 2001 123219-225.
46. Li XX, Zhou XN. Co-infection of tuberculosis and parasitic diseases in humans a systematic review. Parasit Vectors 2013 679.
47. Gordon CA, Acosta LP, Gray DJ, Olveda RM, Jarilla B, Gobert GN, et al. High prevalence of Schistosoma japonicum infection in carabao from Samar Province, the Philippines implications for transmission and control. PLoS Negl Trop Dis 2012 6e1778.
48. González R, Castro P, Garcia F, Plana M, Bayas JM, Lafuente S, et al. Effects of highly active antiretroviral therapy on vaccineinduced humoral immunity in HIV-infected adults. HIV Med 2010 11535-539.
49. Hejdeman B, Leandersson A-C, Fredriksson E-L, Sandström E, Wahren B, Bratt G. Better preserved immune responses after immunization with rgp 160 in HIV-1 infected patients treated with highly active antiretroviral therapy than in untreated patients with similar CD4 levels during at 2 years' followup. HIV Med 2003 4101-110.
50. Young JM, Adetifa IM, Ota MO, Sutherland JS. Expanded polyfunctional T cell response to mycobacterial antigens in TB disease and contraction posttreatment. PLoS One 2010 5e11237.
51. Qiu Z, Zhang M, Zhu Y, Zheng F, Lu P, Liu H, et al. Multifunctional CD4 T cell responses in patients with active tuberculosis. Sci Rep 2012 2216.
52. Matthews K, Ntsekhe M, Syed F, Scriba T, Russell J, Tibazarwa K, et al. HIV-1 infection alters CD4R memory T-cell phenotype at the site of disease in extrapulmonary tuberculosis. Eur J Immunol 2012 42147-157.
53. Wilkinson KA, Wilkinson RJ. Polyfunctional T cells in human tuberculosis. Eur J Immunol 2010 402139-2142.
54. Lahey T, Mitchell BK, Arbeit RD, Sheth S, Matee M, Horsburgh CR, et al. Polyantigenic interferon-g responses are associated with protection from TB among HIV-infected adults with childhood BCG immunization. PLoS One 2011 6e22074.
55. Glatman-Freedman A. The role of antibody-mediated immunity in defense against Mycobacterium tuberculosis advances toward a novel vaccine strategy. Tuberculosis (Edinb) 2006 86191-197.
56. Phuah JY, Mattila JT, Lin PL, Flynn JL. Activated B cells in the granulomas of nonhuman primates infected with Mycobacterium tuberculosis. Am J Pathol 2012 181508-514.
57. Pethe K, Alonso S, Biet F, Delogu G, Brennan MJ, Locht C, et al. The heparin-binding haemagglutinin of M. tuberculosis is required for extrapulmonary dissemination. Nature 2001 412190-194.