WG report backs: New TB Vaccines & TB/HIV INAT Meeting November 12, 2010 Berlin

Goal and strategies for New TB Vaccines Safe and effective in preventing TB - including M/XDR- in children, adolescents and adults, including people with HIV Types of Vaccines –Preexposure –Postexposure (Current BCG vaccine strategy) –Immunotherapy Prime-Boost Strategy –Boost BCG or a recombinant BCG (rBCG) with a second, different vaccine designed to extend and enhance immune protection –Replace BCG with a recombinant BCG (rBCG) or attenuated live M.tb vaccine as the prime

TB Vaccine Pipeline VPM 1002 Max Planck, Vakzine Projekt Mgmt, TBVI rBCG30* UCLA, NIH, NIAID, Aeras AdAg85A McMaster University Hybrid-I+CAF01 SSI Hyvac 4/ AERAS-404 SSI, Sanofi-Pasteur, Aeras, Intercell RUTI Archivel Farma M smegmatis* Hybrid-I+IC31 SSI, TBVI, Intercell M72 GSK, Aeras MVA85A/ AERAS-485 Oxford-Emergent Tuberculosis Consortium (OETC), Aeras AERAS-402/ Crucell Ad35 Crucell, Aeras M vaccae* Immodulon, NIH Preclinical Phase IIPhase IIIPhase IIbPhase I *indicates candidates that have been in clinical trials in the past, but are not currently being tested in clinical trials Source: Tuberculosis Vaccine Candidates – 2009; Stop TB Partnership Working Group on New TB Vaccines As of November 2009 AERAS-422 Aeras Mtb [∆lysA ∆panCD ∆secA2] Albert Einstein College of Medicine MTBVAC01 [∆phoP, ∆fad D26] University of Zaragoza, Institute Pasteur, TuBerculosis Vaccine Initiative (TBVI) HBHA Institute Pasteur of Lille, INSERM, TBVI Hybrid 56 Statens Serum Institute (SSI), Aeras, Intercell, TBVI HG85 A/B Shanghai H&G Biotech Prime Boost Post-infection Immunotherapy Preclinical vaccine candidates are not yet in clinical trials, but have been manufactured under Good Manufacturing Practice (GMP) for clinical use and have undergone some preclinical testing that meets regulatory standards.

Facilitating access to New TB Vaccines Include new TB vaccines in EPI programs and extend the system to adolescent/adult vaccination Consider appropriate and innovative licensure procedures to accelerate access to market Strengthen health systems and identify innovative approaches to allow for mass vaccinations Find the “reasonable” balance between affordability, direct and indirect return on investment, societal benefits and sustainable production

Role for INAT? Can INAT play a role in clarifying the regulatory pathway? Help to clarify WHO mechanism (eg. STAG’s role in SAGE) and accelerate pre-qualification (can this process be done in conjunction with phase III studies) Assist in identifying what information is needed and by whom (eg. MOH, EPI and/or NTP) to make decisions about uptake of vaccines on country level

Current priorities of TB/HIV WG 3 I’s - IPT/ICF Guidelines Global Consultation on the implementation considerations for scale-up of Xpert MTB/RIF TB/HIV Collaborative Policy revision Focus on delivery of decentralized HIV services (eg. ART) in TB settings Ensuring linkages between diagnostic and care Systematize and regulate use of GeneXpert at PEPFAR sites

Role of INAT? Influence NACP and HIV service providers Need guidance from INAT on the role they can play for implementation WGs