Table 2 BCG vaccination against leprosy

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1 SAGE evidence to recommendatis framework i Detailed evidence related to the evidence to recommendati table can be found in the background papers preseed to the Strategic Advisory Group of Experts (SAGE) Immunizati in October Questi: Should BCG be recommended, over no vaccinati, to immunocompete individuals to mitigate the burden of leprosy in leprosyendemic couries? Populati: Immunocompete individuals. Iervei: BCG vaccinati. Comparis(s): vaccinati in the coext of routine leprosy corol s. Outcome: Leprosy disease. Background: Although the fight against leprosy has gained csiderable success, with a target for eliminati as a public health problem set in 2000, more than 200,000 cases were reported in The detecti rate of the disease (a proxy of incidence rate) is ly slightly declining at a rate of about 3% per year. 2 Early diagnosis and complete treatme with multi-drug therapy (MDT) remain the key strategies for reducing disease burden. Although not specifically indicated for prevei of leprosy, there is strg evidence that BCG vaccinati is effective to preve leprosy and that it has coributed to the decline in the incidence of the disease 3. Despite known evidence the effectiveness of BCG to preve leprosy, there are no WHO recommendatis for use of BCG for the prevei of leprosy. Several studies from high burden couries have examined the efficacy/ effectiveness of other vaccines and the combinati of post-exposure prophylaxis with BCG at birth. A curre study is assessing the effect of BCG revaccinati amg a large cohort of coacts. 1 accessed September Weekly Epidemiological Record 2012, 3 Setia et al, The role of BCG in prevei of leprosy: a meta-analysis. Lancet Infect Dis Mar;6(3):

2 BENEFITS & HARMS OF THE OPTIONS PROBLEM Benefits of the Are the desirable aicipated effects large? Harms of the Are the aicipated effects small? CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL INFORMATION Is the problem a setting by public health priori? Leprosy is an infectious disease with importa clinical, social, and public health. BCG vaccinati has been associated with reductis in the incidence of leprosy. In 5 trials, the efficacy of BCG vaccine against leprosy was 20-80% and the effectiveness in 6 cohort studies was 41-62% and 20-90% in 17 case-corol studies, respectively. 5 Evidence indicates BCG at birth is effective for preveing future leprosy infecti. One sub-study from a large RCT found effects of a single dose rifampicin (SDR) greater in perss who also received childhood BCG (OR 0.20 (95% CI )). 6 The limited Evidence available does not support an increased safe risk for BCG vaccinati in a populati with a high leprosy burden. With ly limited efficacy of a chemoprophylaxis regimen, the availabili of a vaccine becomes an importa tool. The efficacy of BCG is variable (20-90%) taking io accou differe factors (e.g. age at vaccinati, clinical form, number of doses, pe of study, the latitude of study area). 4 The evidence for BCG re-vaccinati (two RCTs) is incsiste. Limited data efficacy amg differe age groups 4 Merle CS1, Cunha SS, Rodrigues LC. BCG vaccinati and leprosy protecti: review of curre evidence and status of BCG in leprosy corol. Expert Rev Vaccines Feb 5 Smith and Saunders Leprosy. BMJ Clin Evid. Jun 28;2010. pii: Shuring et al., tective effect of the combinati BCG vaccinati and rifampicin prophylaxis in leprosy prevei. Vaccine v 23;27(50):

3 VALUES & PREFERENCES Balance between benefits and harms What is the overall quali of this evidence for the critical outcomes? both neither Unclear Effectiveness of the included studies Very low Low comparis Moderate High Safe of the Evidence of the protective efficacy and effectiveness for BCG vaccine given in infancy is given. In corast, evidence adverse eves is limited. Effects of vaccinati risk of leprosy There is limited evidence of protective efficacy of revaccinati of BCG against leprosy. included studies Very Moderate Low low High 7 How certain is the relative importance of the desirable and outcomes? Values and preferences of the target Importa Possibly importa babl y no importa importa known undesir able outcom es babl y Unc erta in babl y Vari es evidence available although it is assumed that, in general, there is no importa. In the coext of implemeati, same communicati strategies of BCG vaccinati against TB could be used. Whether some individuals are ccerned about the theoretical risk of disseminated BCG disease or systemic BCG-itis to such an exte as to refuse vaccinati is unknown. 7 Richardus JH and Oskam L. tectig people against leprosy: chemoprophylaxis and immunoprophylaxis. Clin Dermatol Jan-Feb;33(1):

4 ACCEPTABILITY EQUITY RESOURCE USE populati: Are the desirable effects large relative to effects? Are the resources required small? research evidence was ideified. Costs of BCG at birth are likely to be mainly related to the cost of the vaccine. In couries with high TB endemici, there is no need for extra resources for BCG as a tool to preve leprosy. However, if BCG vaccinati discoinues, there may be additial costs. Costeffectiveness research evidence was ideified. Given the affordabili of the BCG vaccine, couries will need to csider whether the BCG vaccine is a priori to fund. However, there is an additial benefit of the BCG vaccine being effective in the prevei of two diseases. What would be the impact health inequities? Which opti is acceptable to key stakeholders (Ministries of Health, Immunizati Managers)? Increased Reduced Iervei Com paris Both Neit her Unclear Implemeing BCG vaccine, in particular in resource-cstrained settings, is expected to reduce health inequities related to prevei of leprosy. research evidence was ideified. Administering of the BCG vaccine against leprosy is assumed to be an acceptable opti to key stakeholders. 4

5 FEASIBILITY Which opti is acceptable to target group? Iervei Com paris Both Neit her Unclear research evidence was ideified. However, in some settings vaccinati programs are already performed and appear acceptable. Increasing protecti of the populati against also leprosy by BCG vaccinati is likely to increase acceptabili to the target group. Is the feasible to impleme? bab ly Uncer tai n ba bly Varie s The is feasible if coordinated between maternal child health, EPI and TB. Balance of Undesirable clearly outweigh desirable Undesirable probably outweigh desirable The balance between desirable and is closely balanced or n Desirable probably outweigh Desirable clearly outweigh Type of recommendati We recommend the We suggest csidering recommendati of the We recommend the comparis We recommend against the and the comparis 5

6 Only in the coext of rigorous research Only with targeted mitoring and evaluati Recommendati (text) Only in specific coexts or specific (sub)populatis In couries or settings with a high incidence of TB or leprosy, a single dose of BCG vaccine should be given to neates at birth, or as so as possible thereafter, for prevei of TB and leprosy disease. If it cannot be given at birth, it should be given at the earliest opportuni thereafter and should not be delayed. Any delay in vaccinati may lead to opportunities for known or unknown exposure to TB or leprosy infected coacts. Co-administrati of BCG with the hepatitis B birth dose is safe and strgly recommended. In order to avoid missed opportunities for neatal vaccinati, BCG multi-dose vials should be opened and used despite any wastage of unused vaccine.. If the birth dose was missed, catch-up vaccinati of unvaccinated older infas and children is recommended since evidence shows it is beneficial. Catch-up vaccinati should be de at the earliest cvenie encouer with the health-care system to minimize known or unknown exposure to TB or leprosy infected coacts. Implemeati csideratis BCG vaccinati relies the assumpti of BCG availabili and that it is already routinely administered as part of the natial immunizati programme. Mitoring and evaluati There might be the need to impleme a mitoring system for adverse eves if other vaccines will be used (BCG adverse eves mitoring already part of the EPI) Research priorities Trials new and existing vaccines including studies LepVax, a new sub-unit vaccine are needed. Any novel TB vaccines should also be evaluated for leprosy prevei and vice versa. 6

7 i This Evidence to Recommendati table is based the DECIDE Work Package 5: Strategies for communicating evidence to inform decisis about health system and public health s. Evidence to a recommendati (for use by a guideline panel). 7