Leprosy and tuberculosis Infections and Infestations
Conditions
Interventions
The trial was explained in public meetings with village headmen and to each household as they were visited.
Individuals with a BCG scar were randomised (by vaccine vial*) to receive e
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy 2. Aged over 3 months 3. Born after 1914 4. No history of leprosy or tuberculosis
Exclusion criteria
Exclusion criteria: 1. Aged under 3 months 2. Born before 1914 3. Evidence of past or current leprosy or tuberculosis 4. Severe malnutrition or other severe illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Presence of clinical leprosy, confirmed as certain or probable by an algorithm based upon clinical findings and biopsy, with onset at any time after vaccination until end of 2018. The algorithm for diagnostic certainty is described in detail in Pönnighaus et al, 1987. 2. Presence of clinical tuberculosis, confirmed as certain or probable based on sputum smear, sputum culture, biopsy and GeneXpert, and ascertained at least 6 months after vaccination until end of 2018: 2.1. Pulmonary tuberculosis was considered certain if culture-positive or GeneXpert-positive plus at least one other specimen positive on culture or GeneXpert or microscopy and probable if culture- or GeneXpert- or microscopy-positive but not fulfilling criteria for certain, excluding those with only a single scanty smear (i.e. fewer than 10 bacilli per 100 fields) 2.2. Extrapulmonary tuberculosis was considered certain if confirmed by histology or microscopy or culture/GeneXpert and probable if histology suggestive or clinical lymph node tuberculosis. Note that since only 2 of 96 extrapulmonary TB are 'probable' in new data, it was decided to restrict to histologically or microscopy or culture/GeneXpert confirmed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time since vaccination measured from the date of vaccination to the date when the individual was first seen by project staff with clinical signs (for leprosy) or to the earliest of the date of first diagnostic specimen, or of registration or of start of treatment (for tuberculosis) 2. Tuberculin status at vaccination assessed with RT23 tuberculin (produced by Danish Statens Serum Institut) 2 IU injected intradermally into the volar surface of the forearm. Induration was measured along and across arm after 48 – 72 hours. Average diameter was used in analyses. 3. M tuberculosis lineage assessed using assessed by whole genome sequence, if available, or, if unavailable, by restriction fragment length polymorphism, or spoligotype 4. HIV status assessed by algorithm based upon rapid tests. Individuals considered HIV negative if last negative report was <1 year before or any time after key date and as HIV positive if first positive report was any time before and up to 1 year after key date (unless known HIV negative at the key date). The participant's HIV status was classed as unknown otherwise. Self reports of HIV positivity or ART use were accepted as evidence of HIV positivity | — |
Countries
Malawi
Outcome results
None listed