WG report backs:New TB Vaccines & TB/HIV

INAT Meeting

November 12, 2010

Berlin

Goal and strategies forNew 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 1002Max Planck, Vakzine Projekt Mgmt, TBVI

rBCG30*UCLA, NIH, NIAID, Aeras

AdAg85AMcMaster University

Hybrid-I+CAF01SSI

Hyvac 4/ AERAS-404SSI, Sanofi-Pasteur, Aeras, Intercell

RUTIArchivel Farma

M smegmatis*

Hybrid-I+IC31SSI, TBVI, Intercell

M72GSK, Aeras

MVA85A/AERAS-485Oxford-Emergent Tuberculosis Consortium (OETC), Aeras

AERAS-402/ Crucell Ad35Crucell, Aeras

M vaccae*Immodulon, NIH

Preclinical Phase II Phase 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-422Aeras

Mtb [∆lysA ∆panCD ∆secA2] Albert Einstein College of Medicine

MTBVAC01 [∆phoP, ∆fad D26] University of Zaragoza, Institute Pasteur, TuBerculosis Vaccine Initiative (TBVI)

HBHAInstitute Pasteur of Lille, INSERM, TBVI

Hybrid 56Statens Serum Institute (SSI), Aeras, Intercell, TBVI

HG85 A/BShanghai 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