Tuberculosis
Conditions
Interventions
Randomized, controlled, nonblinded, parallel, two-arms study of the interferon-gamma (an immune response mediator) production induced by the revaccination with Bacille of Calmette-Guérin (BCG) Moreau-
Biological/vaccine
Behavioural
Sponsors
Fundação Oswaldo Cruz - Bahia
Fundação de Amparo à Pesquisa da Bahia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Healthy volunteers; enrolled in the first year of graduate courses of Medicine, Physiotherapy, Dentistry, Nursing, Phonoaudiology, Nutrition or Pharmacy of two universities; with visible/measurable BCG scar; negative in double testing with PPD RT 23 (2 tuberculin units, 7-10 days of interval between tests).
Exclusion criteria
Exclusion criteria: Positive serology for the human immunodifciency virus (HIV 1/2) using an immunoenzimatic assay (ELISA); HIV test refusal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased interferon-gamma production two months after the intervention compared to the baseline in at least 30% of the participants, evaluated in the supernatants of whole blood cultures stimulated with whole H37Rv Mycobacterium tuberculosis antigen, using a multiparametric immunoassay with latex microspheres.;The interferon-gama production was increased by at least 3.3 fold in 46% of the revaccinated volunteers two months after the intervention as compared with the baseline. This increase of at least 3.3-fold was associated with an increased production of this mediator in comparison with the control group one year after the intervention, as well as with levels above the median production within the revaccinated group. The results obtained are described in the journal Vaccine (http://dx.doi.org/10.1016/j.vaccine.2013.04.079) | — |
Secondary
| Measure | Time frame |
|---|---|
| Significatively diminished serum IgE levels (both total and specific to Dermatophagoides pteronyssinus, measured using the ImmunoCAP kit- ImmunoCAP Phadia AB, Uppsala, Sweden), considering an alpha error of 5%, when comparing the values obtained two months after the intervention with the baseline.;Data under analysis. | — |
Countries
Brazil
Contacts
Public ContactTheolis Bessa
Fundação Oswaldo Cruz - Bahia
Outcome results
None listed