Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults

Vaccine

Volumn 32, Issue 31, 2014, Pages 3982-3988

  Hatherill, Mark ^a   Geldenhuys, Hendrik ^a   Pienaar, Bernadette ^a   Suliman, Sara ^a   Chheng, Phalkun ^b   Debanne, Sara M ^b   Hoft, Daniel F ^c   Boom, W Henry ^b   Hanekom, Willem A ^a   Johnson, John L ^b  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c S LOUIS UNIV HLTH SCIENCES CENTER   (United States)

Author keywords

BCG; Isoniazid; LTBI; Revaccination; Safety

Indexed keywords

BCG VACCINE; ISONIAZID; PYRIDOXINE;

ADULT; ANEMIA; ARTICLE; BCG VACCINATION; CHILL; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE DURATION; DRUG ANTIGENICITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG OVERDOSE; DRUG SAFETY; DYSPNEA; ENDOCRINE DISEASE; FATIGUE; FECES COLOR; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE ULCER; INTRADERMAL DRUG ADMINISTRATION; JAUNDICE; LATENT MYCOBACTERIUM TUBERCULOSIS INFECTION; LIVER DISEASE; LIVER TOXICITY; LOSS OF APPETITE; LYMPHADENITIS; LYMPHADENOPATHY; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALAISE; MALE; MEDICATION COMPLIANCE; MUSCULOSKELETAL DISEASE; MYALGIA; MYCOBACTERIUM BOVIS BCG; MYCOBACTERIUM TUBERCULOSIS; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; NEUTROPHILIA; OPEN STUDY; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT DISEASE; REVACCINATION; RHINORRHEA; RISK BENEFIT ANALYSIS; SCAR FORMATION; SIDE EFFECT; SINGLE BLIND PROCEDURE; SKIN APPENDAGE DISEASE; SKIN REDNESS; TONIC CLONIC SEIZURE; TREATMENT DURATION; TUBERCULIN TEST; TUBERCULOSIS; URINE COLOR; UROGENITAL TRACT DISEASE; WEIGHT REDUCTION; WHEEZING; CLINICAL TRIAL; IMMUNIZATION; LATENT TUBERCULOSIS; SOUTH AFRICA; YOUNG ADULT;

ADULT; BCG VACCINE; FEMALE; HUMANS; IMMUNIZATION, SECONDARY; ISONIAZID; LATENT TUBERCULOSIS; MALE; SOUTH AFRICA; TUBERCULIN TEST; YOUNG ADULT;

EID: 84901977648     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.04.084     Document Type: Article

References (43)

1. Zwerling A., et al. The BCG World Atlas: a database of global BCG vaccination policies and practices. PLoS Med 2011, 8(3):e1001012.
2. World Health Organization. Global Tuberculosis Control: WHO Report 2011. Geneva.
3. Mahomed H., et al. The tuberculin skin test versus QuantiFERON TB Gold(R) in predicting tuberculosis disease in an adolescent cohort study in South Africa. PLoS One 2011, 6(3):e17984.
4. Dye C., Williams B.G. Eliminating human tuberculosis in the twenty-first century. J R Soc Interface 2008, 5(23):653-662.
5. Abu-Raddad L.J., et al. Epidemiological benefits of more-effective tuberculosis vaccines: drugs, and diagnostics. Proc Nat Acad Sci USA 2009, 106(33):13980-13985.
6. Arbues A., et al. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine 2013, 31(42):4867-4873.
7. Grode L., et al. Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guerin mutants that secrete listeriolysin. J Clin Invest 2005, 115(9):2472-2479.
8. Grode L., et al. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine 2013, 31(9):1340-1348.
9. Hougardy J.M., et al. Regulatory T cells depress immune responses to protective antigens in active tuberculosis. Am J Respir Crit Care Med 2007, 176(4):409-416.
10. Armstrong J.A., Hart P. Response of cultured macrophages to Mycobacterium tuberculosis, with observations on fusion of lysosomes with phagosomes. J Exp Med 1971, 134:713-740.
11. Vergne I., et al. Mechanism of phagolysosome biogenesis block by viable Mycobacterium tuberculosis. Proc Nat Acad Sci USA 2005, 102(11):4033-4038.
12. Walburger A., et al. Protein kinase G from pathogenic mycobacteria promotes survival within macrophages. Science 2004, 304(5678):1800-1804.
13. Xu S., et al. Intracellular trafficking in Mycobacterium tuberculosis and Mycobacterium avium-infected macrophages. J Immunol 1994, 153(6):2568-2578.
14. von Reyn C.F., et al. Prevention of tuberculosis in bacille Calmette-Guerin-primed: HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine. Aids 2010, 24(5):675-685.
15. Rook G.A., al Attiyah R., Filley E. New insights into the immunopathology of tuberculosis. Pathobiology 1991, 59(3):148-152.
16. Rook G.A., Stanford J.L. The Koch phenomenon and the immunopathology of tuberculosis. Curr Top Microbiol Immunol 1996, 215:239-262.
17. Walker K.B., et al. The second Geneva Consensus: recommendations for novel live TB vaccines. Vaccine 2010, 28(11):2259-2270.
18. Leung C.C., et al. Efficacy of the BCG revaccination programme in a cohort given BCG vaccination at birth in Hong Kong. Int J Tuberc Lung Dis 2001, 5(8):717-723.
19. Karonga Prevention Trial Group Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Lancet 1996, 348(9019):17-24.
20. Ponnighaus J.M., et al. Efficacy of BCG vaccine against leprosy and tuberculosis in northern Malawi. Lancet 1992, 339(8794):636-639.
21. World Health Organization BCG vaccine. WHO position paper. Wkly Epidemiol Rec 2004, 27-38.
22. Rodrigues L.C., et al. Effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: the BCG-REVAC cluster-randomised trial. Lancet 2005, 366(9493):1290-1295.
23. Barreto M.L., et al. Evidence of an effect of BCG revaccination on incidence of tuberculosis in school-aged children in Brazil: second report of the BCG-REVAC cluster-randomised trial. Vaccine 2011, 29(31):4875-4877.
24. FitzGerald J.M. Management of adverse reactions to bacille Calmette-Guerin vaccine. Clin Infect Dis 2000, 31(3):S75-S76.
25. Hoft D.F., et al. Clinical reactogenicity of intradermal bacille Calmette-Guerin vaccination. Clin Infect Dis 1999, 28(4):785-790.
26. Baily G.V. Tuberculosis prevention Trial, Madras. Indian J Med Res 1980, 72:1-74.
27. Wilkinson K.A., et al. Effect of treatment of latent tuberculosis infection on the T cell response to Mycobacterium tuberculosis antigens. J Infect Dis 2006, 193(3):354-359.
28. Kopanoff D.E., Snider D.E., Caras G.J. Isoniazid-related hepatitis: a U.S. Public Health Service cooperative surveillance study. Am Rev Respir Dis 1978, 117(6):991-1001.
29. Andrews J.R., et al. Risk of progression to active tuberculosis following reinfection with Mycobacterium tuberculosis. Clin Infect Dis 2012, 54(6):784-791.
30. Brooks-Pollock E., et al. Epidemiologic inference from the distribution of tuberculosis cases in households in Lima: Peru. J Infect Dis 2011, 203(11):1582-1589.
31. National Tuberculosis Control Programme (NTCP) The South African tuberculosis control programme practical guidelines 2000 2000, Department of Health, Republic of South Africa. D. RoSA (Ed.).
32. Mahomed H., et al. Comparison of mantoux skin test with three generations of a whole blood IFN-gamma assay for tuberculosis infection. Int J Tuberc Lung Dis 2006, 10(3):310-316.
33. Mahomed H., et al. Predictive factors for latent tuberculosis infection among adolescents in a high-burden area in South Africa. Int J Tuberc Lung Dis 2011, 15(3):331-336.
34. Dourado I., et al. Rates of adverse reactions to first and second doses of BCG vaccination: results of a large community trial in Brazilian schoolchildren. Int J Tuberc Lung Dis 2003, 7(4):399-402.
35. Bottiger M., et al. A comparative study of Danish (Statens Seruminstitut): Glaxo and Behringwerke vaccines-revaccination of schoolchildren. J Biol Stand 1983, 11(1):1-12.
36. Global Tuberculosis Programme and Global Programme on Vaccines, Statement on BCG revaccination for the prevention of tuberculosis. Wkly Epidemiol Rec 1995:229-231.
37. Karonga Prevention Trial Group Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Lancet 1996, 348:17-24.
38. Hesseling A.C., et al. Consensus statement on the revised World Health Organization recommendations for BCG vaccination in HIV-infected infants. Int J Tuberc Lung Dis 2008, 12(12):1376-1379.
39. Hawkridge T., et al. Safety and immunogenicity of a new tuberculosis vaccine: MVA85A, in healthy adults in South Africa. J Infect Dis 2008, 198(4):544-552.
40. Scriba T.J., 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(1):279-290.
41. Scriba T.J., et al. A phase IIa trial of the new tuberculosis vaccine: MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults. Am J Respir Crit Care Med 2012, 185(7):769-778.
42. Gray D.M., Zar H., Cotton M. Impact of tuberculosis preventive therapy on tuberculosis and mortality in HIV-infected children. Cochrane Database Syst Rev 2009, 1:CD006418.
43. Johnson J.L., et al. Effect of isoniazid therapy for latent TB infection on QuantiFERON-TB gold in-tube responses in adults with positive tuberculin skin test results in a high TB incidence area: a controlled study. Chest 2014, 145(3):612-617.