Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: A randomised, placebo-controlled phase 2b trial

The Lancet

Volumn 381, Issue 9871, 2013, Pages 1021-1028

  Tameris, Michele D ^a   Hatherill, Mark ^a   Landry, Bernard S ^b   Scriba, Thomas J ^a   Snowden, Margaret Ann ^b   Lockhart, Stephen ^c,d   Shea, Jacqueline E ^c   McClain, J Bruce ^b   Hussey, Gregory D ^a,f   Hanekom, Willem A ^a   Mahomed, Hassan ^a,g   McShane, Helen ^e  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b AERAS   (United States)

^c Oxford Emergent Tuberculosis Consortium   (United Kingdom)

^d Emergent Biosolutions   (United Kingdom)

^e UNIVERSITY OF OXFORD   (United Kingdom)

^f UNIVERSITY OF CAPE TOWN   (South Africa)

^g STELLENBOSCH UNIVERSITY   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

BCG VACCINE; GAMMA INTERFERON; INTERLEUKIN 2; TUMOR NECROSIS FACTOR ALPHA;

ARTICLE; CHILD CARE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; GASTROENTERITIS; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFANT; LOWER RESPIRATORY TRACT INFECTION; MALE; NORMAL HUMAN; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOUTH AFRICA; TUBERCULOSIS; VACCINATION;

EID: 84875382846     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(13)60177-4     Document Type: Article

References (33)

1. WHO. Global tuberculosis report 2012. http://apps.who.int/iris/bitstream/ 10665/75938/1/9789241564502-eng.pdf (accessed Jan 2, 2013).
2. Stop TB Partnership. The global plan to stop TB 2011-2015. http://www.stoptb.org/global/plan/(accessed Jan 2, 2013).
3. Trunz B, Fine P, Dye C. Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a me ta-analysis and assessment of cost-effectiveness. Lancet 2006; 367: 1173-80.
4. Rodrigues L, Diwan V, Wheeler J, et al. P rotective effect of BCG against tuberculous meningitis and miliary tuberculosis: a meta-analysis. Int J Epidemiol 1993; 22: 1154-58.
5. Fine P. Variation in protection by BCG: implications of and for heterologous immunity. Lancet 1995; 346: 1339-45.
6. Colditz GA, Berkey CS, Mosteller F, et al. The efficacy of bacillus Calmette-Guerin vaccination of newborns and infants in the pre vention of tuberculosis: meta-analyses of the published literature. Pediatrics 1995; 96: 29-35.
7. Basu Roy R, Sotgiu G, Altet-Gomez N, et al. Identifying predictors of interferon-gamma release assay results in pediatric latent tuberculosis: a protective role of bacillus Calmette-Guerin?: a pTB-NET collaborative study. Am J Respir Crit Care Med 2012; 186: 378-84.
8. Mahomed H, Kibel M, Hawkridge T, et al. The impact of a change in bacille Calmette-Guerin vaccine policy on tuberculosis incidence in children in Cape Town, South Africa. Pediatr Infect Dis J 2006; 25: 1167-72.
9. Moyo S, Verver S, Mahomed H, et al. Age-related tuberculosis incidence and severity in children under 5 years of age in Cape Town, South Africa. Int J Tuberc Lung Dis 2010; 14: 149-54.
10. Brennan MJ, Thole J. Tuberculosis vaccines: a strategic bl ueprint for the next decade. Tuberculosis (Edinb) 2012; 92 (suppl 1): S6-13.
11. McShane H, Pathan A, Sander C, et al. Recombinant modified vaccinia virus Ankara expressing antigen 85A boo sts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med 2004; 10: 1240-44.
12. Vordermeier H, Villarreal-Ramos B, Cockle P, et al. Viral booster vaccines improve Mycobacterium bovis BCG-induced protection against bovine tuberculosis. Infect Immun 2009; 77: 3364-73.
13. Verreck F, Vervenne R, Kondova I, et al. MVA85A boostin g of BCG and an attenuated, phoP deficient M tuberculosis vaccine both show protective efficacy against tuberculosis in rhesus macaques. PloS One 2009; 4: e5264.
14. Goonetilleke N, McShane H, Hannan C, Anderson R, Brookes R, Hill A. Enhanced immunogenicity and protective efficacy against Mycobacterium tuberculosis of bacille Calmette-Guerin vaccine using mucosal administration and boosting with a recombinan t modified vaccinia virus Ankara. J Immunol 2003; 171: 1602-09.
15. Williams A, Goonetilleke NP, McShane H, et al. Boosting with poxviruses enhances Mycobacterium bovis BCG efficacy against tuberculosis in guinea pigs. Infect Immun 2005; 73: 3814-16.
16. Scriba TJ, Tameris M, Mansoor N, et al. Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants. J Infect Dis 2011; 203: 1832-43.
17. Ota M, Odutola A, Owiafe P, et al. Immunogenicity of the tuberculosis va ccine MVA85A is reduced by coadministration with EPI vaccines in a randomized controlled trial in Gambian infants. Sci Transl Med 2011; 3: 88ra56.
18. Kaufmann SH. Fact and fiction in tuberculosis vaccine research: 10 years later. Lancet Infect Dis 2011; 11: 633-40.
19. Hanekom W, Dockrell H, OttenhoffT, et al. Immunologica l outcomes of new tuberculosis vaccine trials: WHO panel recommendations. PLoS Med 2008; 5: e145.
20. Baily GV. Tuberculosis prevention trial, Madras. Indian J Med Res 1980; 72 (suppl): 1-74.
21. Hawkridge A, Hatherill M, Little F, et al. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: r andomised trial. BMJ 2008; 337: 1275-82
22. Tameris M, McShane H, McClain J, et al. Lessons le arnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG. Tuberculosis (Edin) (in press).
23. Scriba TJ, Tameris M, Mansoor N, et al. Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells. Eur J Immunol 2010; 40: 279-90.
24. Moyo S, Verver S, Hawkridge A, et al. Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial. Int J Tuberc Lung Dis 2012; 16: 185-91.
25. Meyer J, Harris S, Satti I, et al. Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery. Vaccine 2013; 31: 1026-33.
26. Hatherill M. Safety and immunogenicity of MVA85A pr ime and bacille Calmette-Guérin boost vaccination (MVA(TB)029). http://www. clinicaltrials.gov/ct2/show/NCT1650389 (accessed Jan 29, 2013).
27. Kagina B, Abel B, Scriba T, et al. Specific T cell frequency and cytokine expression profile do not correlate with protection against tuberculosis after bacillus Calmette-Guerin vaccination of newborns. Am J Resp Crit Care Med 2010; 182: 1073-79.
28. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med 2009; 361: 2209-20.
29. Rts SCTP, Agnandji S, Lell B, et al. A phase 3 trial of RTS, S/AS01 malaria vaccine in African infants. N Engl J Med 2012; 367: 2284-95.
30. Taylor J, Turner O, Basaraba R, Belisle J, Huygen K, Orme I. Pulmonary necrosis resulting from DNA vaccination against tuberculosis. Infect Immun 2003; 71: 2192-98.
31. ® assay in young children investigated for tuberculosis in South Africa. Int J Tuberc Lung Dis 2011; 15: 1176-81.
32. Graham S, Ahmed T, Amanullah F, et al. Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tu berculosis disease. Consensus from an expert panel. J Infect Dis 2012; 205 (Suppl 2): S199-208.
33. Hatherill M, Verver S, Mahomed H, et al. Consensus statement on diagnostic end points for infan t tuberculosis vaccine trials. Clin Infect Dis 2012; 54: 493-501.