Potential implementation strategies, acceptability, and feasibility of new and repurposed TB vaccines

Abstract

Recently, two Phase 2B tuberculosis vaccine trials reported positive efficacy results in adolescents and adults. However, experience in vaccinating these age groups is limited. We identified potential implementation strategies for the M72/AS01E vaccination and BCG-revaccination-like candidates and explored their acceptability and feasibility. We conducted in-depth semi-structured interviews among key decision makers to identify implementation strategies and target groups in South Africa, India, and China. Thematic and deductive analysis using a coding framework were used to identify themes across and within settings. In all three countries there was interest in novel TB vaccines, with school-attending adolescents named as a likely target group. In China and India, older people were also identified as a target group. Routine vaccination was preferred in all countries due to stigma and logistical issues with targeted mass campaigns. Perceived benefits for implementation of M72/AS01E were the likely efficacy in individuals with Mycobacterium tuberculosis (Mtb) infection and efficacy for people living with HIV. Perceived challenges for M72/AS01E included the infrastructure and the two-dose regimen required. Stakeholders valued the familiarity of BCG but were concerned about the adverse effects in people living with HIV, a particular concern in South Africa. Implementation challenges and opportunities were identified in all three countries. Our study provides crucial information for implementing novel TB vaccines in specific target groups and on country specific acceptability and feasibility. Key groups for vaccine implementation in these settings were identified, and should be included in clinical trials and implementation planning.

New tuberculosis vaccines in India: Modelling the potential health and economic impacts of adolescent/adult vaccination with M72/AS01Eand BCG-revaccination

“…We modelled a subset of delivery scenarios, which may differ from the strategies India will choose. We evaluated numerous age-targeting alternatives informed by expert opinion and results from interviews with key decision-makers in India, 30 but did not investigate targeting specific groups, such as healthcare workers, people completing tuberculosis treatment, or household contacts of people with tuberculosis, who could be at high risk of developing tuberculosis disease and may be prioritised for vaccination. This strategy has previously been suggested to have a high population-level impact per individual vaccinated, 31,32 and is an important aspect for future country-level models to address, to support decision making.…”

Feasibility of novel adult tuberculosis vaccination in South Africa: a cost-effectiveness and budget impact analysis

“…Participants were chosen based on their expertise (TB, vaccines, vaccine policy, vaccine supply, and vaccine delivery), sector (civil society, academic, Ministry of Health, Ministry of Finance, or membership in a non-governmental organisation), and scope (national, regional, and local level). Further details of the interview process and summary of responses are described in Pelzer et al 19 , Supplementary Note 1 and Supplementary Table 5 .…”

Mapping the Existing Body of Knowledge on New and Repurposed TB Vaccine Implementation: A Scoping Review

“…Various strategies for TB vaccine implementation were identified, which are summarized in table 10. Target populations that were similar across the countries were adolescents, adults, socially vulnerable groups, PLHIV and other people with immunocompromised systems, and healthcare workers 34,35 . The elderly and high risk contacts were target populations evaluated in India and China 34 and in South Africa the mining-community was evaluated as a target population 21 .…”

“…Target populations that were similar across the countries were adolescents, adults, socially vulnerable groups, PLHIV and other people with immunocompromised systems, and healthcare workers 34,35 . The elderly and high risk contacts were target populations evaluated in India and China 34 and in South Africa the mining-community was evaluated as a target population 21 . In the Indian context, a focus on high-risk populations by targeting high incidence geographic 'hotspots' was also assessed 22 .…”