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Impact of isoniazid preventive therapy on the evaluation of long-term effectiveness of infant MVA85A vaccination.
Bunyasi, E W; Luabeya, A K K; Tameris, M; Geldenhuys, H; Mulenga, H; Landry, B S; Scriba, T J; Schmidt, B-M; Hanekom, W A; Mahomed, H; McShane, H; Hatherill, M.
Affiliation
  • Bunyasi EW; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Luabeya AKK; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Tameris M; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Geldenhuys H; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Mulenga H; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Landry BS; Aeras, Rockville, Maryland, USA.
  • Scriba TJ; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Schmidt BM; Department of Social and Behavioral Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town.
  • Hanekom WA; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
  • Mahomed H; Department of Health, Western Cape and Division of Community Health, Stellenbosch University, Stellenbosch, South Africa.
  • McShane H; Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
  • Hatherill M; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Int J Tuberc Lung Dis ; 21(7): 778-783, 2017 07 01.
Article in En | MEDLINE | ID: mdl-28633702
ABSTRACT

SETTING:

South Africa.

OBJECTIVE:

To evaluate the long-term effectiveness of infant modified vaccinia Ankara virus-expressing antigen 85A (MVA85A) vaccination against tuberculosis (TB).

DESIGN:

We analysed data from a double-blind randomised placebo-controlled Phase 2b MVA85A infant TB vaccine trial (2009-2012), with extended post-trial follow-up (2012-2014). Isoniazid preventive therapy (IPT) was provided by public health services according to national guidelines. The primary outcome was curative treatment for TB disease. Survival analysis and Poisson regression were used for study analysis.

RESULTS:

Total follow-up was 10 351 person-years of observation (pyo). Median follow-up age was 4.8 years (interquartile range 4.4-5.2). There were 328 (12%) TB cases. TB disease incidence was 3.2/100 pyo (95%CI 2.8-3.5) overall, and respectively 3.3 (95%CI 2.9-3.9) and 3.0 (95%CI 2.6-3.5)/100 pyo in the MVA85A vaccine and placebo arms. A total of 304 children (11%) received IPT, with respectively 880 and 9471 pyo among IPT and non-IPT recipients. There were 23 (7.6%) TB cases among 304 IPT recipients vs. 305 (12.9%) among 2374 non-IPT recipients (P = 0.008). IPT effectiveness was 85% (95%CI 76-91).

CONCLUSION:

Extended follow-up confirms no long-term effectiveness of infant MVA85A vaccination, but a six-fold reduction in TB risk can be attributed to IPT. National TB programmes in high TB burden countries should ensure optimal implementation of IPT for eligible children.
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Full text: 1 Database: MEDLINE Main subject: Tuberculosis / Tuberculosis Vaccines / Isoniazid / Antitubercular Agents Type of study: Clinical_trials / Guideline / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Child, preschool / Female / Humans / Infant / Male Country/Region as subject: Africa Language: En Year: 2017 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Tuberculosis / Tuberculosis Vaccines / Isoniazid / Antitubercular Agents Type of study: Clinical_trials / Guideline / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Child, preschool / Female / Humans / Infant / Male Country/Region as subject: Africa Language: En Year: 2017 Type: Article