Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: A phase 1, double-blind, randomised controlled trial

The Lancet Infectious Diseases

Volumn 14, Issue 10, 2014, Pages 939-946

  Satti, Iman ^a   Meyer, Joel ^a   Harris, Stephanie A ^a   Thomas, Zita Rose Manjaly ^a   Griffiths, Kristin ^a   Antrobus, Richard D ^a   Rowland, Rosalind ^a   Ramon, Raquel Lopez ^a   Smith, Mary ^a   Sheehan, Sharon ^a   Bettinson, Henry ^b   McShane, Helen ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b CHURCHILL HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BCG VACCINE; PLACEBO; AEROSOL; BACTERIAL ANTIGEN;

ADULT; AEROSOL; ANTIBODY BLOOD LEVEL; ARTHRALGIA; ARTICLE; BCG VACCINATION; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CLINICAL EVALUATION; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG DELIVERY SYSTEM; DRUG FEVER; DRUG INDUCED HEADACHE; DYSPNEA; ERYTHEMA; FATIGUE; FEMALE; HEMOPTYSIS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; INJECTION SITE SWELLING; LUNG LAVAGE; MALAISE; MALE; MEDICAL NEBULIZER; MODIFIED VACCINIA VIRUS ANKARA; MYALGIA; NAUSEA AND VOMITING; NORMAL HUMAN; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SKIN PAIN; SKIN SWELLING; SORE THROAT; THORAX PAIN; VACCINIA VIRUS; WHEEZING; ADVERSE EFFECTS; CLINICAL TRIAL; IMMUNOLOGY; INHALATIONAL DRUG ADMINISTRATION; INTRADERMAL DRUG ADMINISTRATION; MIDDLE AGED; MYCOBACTERIUM BOVIS; SAFETY; STANDARDS; TUBERCULOSIS; VACCINATION; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADULT; AEROSOLS; ANTIGENS, BACTERIAL; BCG VACCINE; CD4-POSITIVE T-LYMPHOCYTES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNITY, CELLULAR; INJECTIONS, INTRADERMAL; MALE; MIDDLE AGED; MYCOBACTERIUM BOVIS; SAFETY; TUBERCULOSIS; TUBERCULOSIS VACCINES; VACCINATION; YOUNG ADULT;

EID: 84908137673     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(14)70845-X     Document Type: Article

References (30)

1. Global tuberculosis report 2013, (accessed Feb 21, 2013). http://www.who.int/tb/publications/global_report/en/.
2. Trunz BB, Fine P, Dye C Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectiveness. Lancet 2006, 367:1173-1180.
3. Colditz GA, Brewer TF, Berkey CS, et al. Efficacy of BCG vaccine in the prevention of tuberculosis. Meta-analysis of the published literature. JAMA 1994, 271:698-702.
4. McShane H, Pathan AA, Sander CR, et al. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med 2004, 10:1240-1244.
5. Rodrigues LC, Diwan VK, Wheeler JG Protective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. Int J Epidemiol 1993, 22:1154-1158.
6. Santosuosso M, McCormick S, Zhang X, Zganiacz A, Xing Z Intranasal boosting with an adenovirus-vectored vaccine markedly enhances protection by parenteral Mycobacterium bovis BCG immunization against pulmonary tuberculosis. Infect Immun 2006, 74:4634-4643.
7. Gherardi MM, Esteban M Recombinant poxviruses as mucosal vaccine vectors. J Gen Virol 2005, 86:2925-2936.
8. White AD, Sibley L, Dennis MJ, et al. Evaluation of the safety and immunogenicity of a candidate tuberculosis vaccine, MVA85A, delivered by aerosol to the lungs of macaques. Clin Vaccine Immunol 2013, 20:663-672.
9. Sabin AB Immunization against measles by aerosol. Rev Infect Dis 1983, 5:514-523.
10. British Thoracic Society guidelines on diagnostic flexible bronchoscopy. Thorax 2001, 56(suppl 1):i1-21. British Thoracic Society Bronchoscopy Guidelines Committee, a Subcommittee of Standards of Care Committee of British Thoracic Societya Subcommittee of Standards of Care Committee of British Thoracic Society.
11. Meyer J, Harris SA, Satti I, et al. Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery. Vaccine 2013, 31:1026-1033.
12. Rowland R, Pathan AA, Satti I, Poulton ID, et al. Safety and immunogenicity of an FP9-vectored candidate tuberculosis vaccine (FP85A), alone and with candidate vaccine MVA85A in BCG-vaccinated healthy adults: a phase I clinical trial. Hum Vaccin Immunother 2013, 9:50-62.
13. Hanekom WA, Hughes J, Mavinkurve M, et al. Novel application of a whole blood intracellular cytokine detection assay to quantitate specific T-cell frequency in field studies. J Immunol Methods 2004, 291:185-195.
14. Beveridge NE, Price DA, Casazza JP, et al. Immunisation with BCG and recombinant MVA85A induces long-lasting, polyfunctional Mycobacterium tuberculosis-specific CD4+ memory T lymphocyte populations. Eur J Immunol 2007, 37:3089-3100.
15. Chapman RS, Cross KW, Fleming DM The incidence of shingles and its implications for vaccination policy. Vaccine 2003, 21:2541-2547.
16. Kupferschmidt K Infectious disease. Taking a new shot at a TB vaccine. Science 2011, 334:1488-1490.
17. Flynn JL, Chan J, Triebold KJ, Dalton DK, Stewart TA, Bloom BR An essential role for interferon gamma in resistance to Mycobacterium tuberculosis infection. J Exp Med 1993, 178:2249-2254.
18. Roach DR, Bean AG, Demangel C, France MP, Briscoe H, Britton WJ TNF regulates chemokine induction essential for cell recruitment, granuloma formation, and clearance of mycobacterial infection. J Immunol 2002, 168:4620-4627.
19. Millington KA, Innes JA, Hackforth S, et al. Dynamic relationship between IFN-gamma and IL-2 profile of Mycobacterium tuberculosis-specific T cells and antigen load. J Immunol 2007, 178:5217-5226.
20. Khader SA, Bell GK, Pearl JE, et al. IL-23 and IL-17 in the establishment of protective pulmonary CD4+ T cell responses after vaccination and during Mycobacterium tuberculosis challenge. Nat Immunol 2007, 8:369-377.
21. Santosuosso M, Zhang X, McCormick S, Wang J, Hitt M, Xing Z Mechanisms of mucosal and parenteral tuberculosis vaccinations: adenoviral-based mucosal immunization preferentially elicits sustained accumulation of immune protective CD4 and CD8 T cells within the airway lumen. J Immunol 2005, 174:7986-7994.
22. Mogues T, Goodrich ME, Ryan L, LaCourse R, North RJ The relative importance of T cell subsets in immunity and immunopathology of airborne Mycobacterium tuberculosis infection in mice. J Exp Med 2001, 193:271-280.
23. Flynn JL, Goldstein MM, Triebold KJ, Koller B, Bloom BR Major histocompatibility complex class I-restricted T cells are required for resistance to Mycobacterium tuberculosis infection. Proc Natl Acad Sci USA 1992, 89:12013-12017.
24. Silver RF, Zukowski L, Kotake S, et al. Recruitment of antigen-specific Th1-like responses to the human lung following bronchoscopic segmental challenge with purified protein derivative of Mycobacterium tuberculosis. Am J Respir Cell Mol Biol 2003, 29:117-123.
25. Chackerian AA, Perera TV, Behar SM Gamma interferon-producing CD4+ T lymphocytes in the lung correlate with resistance to infection with Mycobacterium tuberculosis. Infect Immun 2001, 69:2666-2674.
26. Yang ZY, Wyatt LS, Kong WP, Moodie Z, Moss B, Nabel GJ Overcoming immunity to a viral vaccine by DNA priming before vector boosting. J Virol 2003, 77:799-803.
27. Tameris MD, Hatherill M, Landry BS, et al. Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial. Lancet 2013, 381:1021-1028.
28. Barclay WR, Busey WM, Dalgard DW, et al. Protection of monkeys against airborne tuberculosis by aerosol vaccination with bacillus Calmette-Guerin. Am Rev Respir Dis 1973, 107:351-358.
29. Walrath JR, Silver RF The alpha4beta1 integrin in localization of Mycobacterium tuberculosis-specific T helper type 1 cells to the human lung. Am J Respir Cell Mol Biol 2011, 45:24-30.
30. Rosenthal SR, McEnery JT, Raisys N Aerogenic BCG vaccination against tuberculosis in animal and human subjects. J Asthma Res 1968, 5:309-323.