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Int J Infect Dis. 2019 Sep 6. pii: S1201-9712(19)30365-0. doi: 10.1016/j.ijid.2019.08.035. [Epub ahead of print]

Effectiveness of single dose rifampicin after BCG-vaccination to prevent leprosy in close contacts of patients with newly diagnosed leprosy: a cluster randomized controlled trial.

Author information

1
Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands; Department of Infectious Diseases, Leiden University Medical Centre, The Netherlands. Electronic address: j.richardus@erasmusmc.nl.
2
Rural Health Program, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.
3
Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
4
Department of Infectious Diseases, Leiden University Medical Centre, The Netherlands.

Abstract

OBJECTIVE:

To assess the effectiveness of SDR after BCG-vaccination in preventing leprosy in contacts.

DESIGN:

Single-centre, cluster-randomized controlled trial.

SETTING:

Leprosy control programme in northwest Bangladesh.

PARTICIPANTS:

14,988 contacts of 1,552 new leprosy patients; randomized in the SDR- arm (7,379) and SDR + arm (7,609).

INTERVENTIONS:

Intervention group: BCG-vaccination followed by SDR 8-12 weeks later.

CONTROL GROUP:

BCG only.

FOLLOW-UP:

at one and two years after intake.

MAIN OUTCOME MEASURE:

The occurrence of leprosy.

RESULTS:

The incidence rate per 10,000 person-years-at-risk was 44 in the SDR- arm and 31 in the SDR + at 1 year, and 34 in the SDR- arm and 41 in the SDR + arm at 2 years. There was a statistically non-significant (p = 0.148; 42%) reduction for PB leprosy in the SDR + arm at 1 year. Of all new cases, 33.6% appeared within 8-12 weeks after BCG-vaccination.

CONCLUSION:

In the first year, SDR after BCG-vaccination reduced PB leprosy incidence among contacts by 42%. This was a statistically non-significant reduction due to the limited number of cases after SDR was administered. To which extent SDR suppresses excess leprosy cases after BCG-vaccination is difficult to establish because many appeared before the SDR intervention.

TRIAL REGISTRATION:

Netherlands Trial Register: NTR3087.

KEYWORDS:

Bacillus Calmette-Guérin vaccine; chemoprophylaxis; household contacts; immunoprophylaxis; leprosy; rifampicin

PMID:
31499206
DOI:
10.1016/j.ijid.2019.08.035
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