Abstract
The M72/AS01E tuberculosis vaccine showed 50% (95%CI: 2–74%) efficacy in a phase 2B trial in preventing active pulmonary tuberculosis disease, but potential cost-effectiveness of adolescent immunisation is unknown. We estimated the impact and cost-effectiveness of six scenarios of routine adolescent M72/AS01E-like vaccination in South Africa and India. All scenarios suggested an M72/AS01E-like vaccine would be highly (94–100%) cost-effective in South Africa compared to a cost-effectiveness threshold of $2480/disability-adjusted life-year (DALY) averted. For India, a prevention of disease vaccine, effective irrespective of recipient’s M. tuberculosis infection status at time of administration, was also highly likely (92–100%) cost-effective at a threshold of $264/DALY averted; however, a prevention of disease vaccine, effective only if the recipient was already infected, had 0–6% probability of cost-effectiveness. In both settings, vaccinating 50% of 18 year-olds was similarly cost-effective to vaccinating 80% of 15 year-olds, and more cost-effective than vaccinating 80% of 10 year-olds. Vaccine trials should include adolescents to ensure vaccines can be delivered to this efficient-to-target population.
Highlights
The M72/AS01E tuberculosis vaccine showed 50% (95%CI: 2–74%) efficacy in a phase 2B trial in preventing active pulmonary tuberculosis disease, but potential cost-effectiveness of adolescent immunisation is unknown
It allows us to assess the relative importance of routinely vaccinating adolescents with diseasepreventing vaccines that are (i) effective irrespective of whether the recipient is infected with M. tuberculosis at the time of vaccination (“pre- and post-infection efficacy”); or (ii) effective only when the recipient is already infected with M. tuberculosis (“postinfection efficacy”), see Box 1
We modelled vaccine types which were differentially effective depending on whether the recipient was infected by Mycobacterium tuberculosis (Mtb):
Summary
The M72/AS01E tuberculosis vaccine showed 50% (95%CI: 2–74%) efficacy in a phase 2B trial in preventing active pulmonary tuberculosis disease, but potential cost-effectiveness of adolescent immunisation is unknown. We estimated the impact and cost-effectiveness of six scenarios of routine adolescent M72/AS01E-like vaccination in South Africa and India. For India, a prevention of disease vaccine, effective irrespective of recipient’s M. tuberculosis infection status at time of administration, was highly likely (92–100%) cost-effective at a threshold of $264/DALY averted; a prevention of disease vaccine, effective only if the recipient was already infected, had 0–6% probability of cost-effectiveness. Previous work has estimated the epidemiological impact of hypothetical or pipeline vaccines to prevent tuberculosis infection and/or disease[6,7,8], including the impact of a post-exposure vaccine on drug-resistant tuberculosis[9,10], and when delivered via routine immunisation of 9-year-olds accompanied by recurring mass campaigns to adolescents/adults[10,11]. We simulate three scenarios of routine adolescent vaccination, assuming a coverage of 80% is reached among 10-year-olds and 15-year-olds, and that a lower coverage of 50% is reached among 18-year-olds, to reflect potential difficulties in reaching older adolescents in vaccination campaigns
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