PPC: For therapeutic tuberculosis (TB) vaccines
WHO Preferred Product Characteristics for Therapeutic Vaccines to Improve Tuberculosis Treatment Outcomes Family
14 June 2019
Indication
Protection against TB recurrence, following initial cure. Increase the proportion of cure at end of drug treatment.
Target population
All persons being treated for active TB, both drug sensitive and drug resistant Mycobacterium tuberculosis strains.
Efficacy
50% or greater efficacy in reducing the rate of recurrent TB after a standard course of drug treatment, and/or 50% or greater reduction in treatment failure at the end of drug treatment.
Safety
A safety and reactogenicity profile similar to other current WHO-recommended routine vaccines for use in adolescents and adults would be preferred.
Product type
Vaccine
Status
Active
Safety
Dose regimen: A minimal number of doses required. A requirement for more than three doses to achieve immunization would not be desirable due to logistical and cost concerns. Durability of protection: Initial proof-of-concept for prevention of recurrence could be demonstrated on the basis of one year of follow-up.
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