References TB Vaccine Development Pathway

The TB Vaccine Development Pathway

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Product Characterization and Quality

Stage A
ICH Q11
Stage A
ICH Q2
Stage A
ICH Q8
Stage A
New live mycobacterial vaccines: the Geneva consensus on essential steps towards clinical development

Arun T. Kamatha, UliFruth, Michael J. Brennan, Roland Dobbelaer, Peter Hubrechts, Mei Mei Ho, Ronald E. Mayner, Jelle Thole, Barry Walker, Margaret Liu, Paul-Henri Lambert

Stage A
The second Geneva Consensus: Recommendations for novel live TB vaccines

B.Walker, M.J.Brennan, M.M.Ho, J.Eskola, G.Thiry, J.Sadoff, R.Dobbelaer, L.Grode, M.A.Liu, U.Fruth, P.H.Lambert

Production Process

Stage B
ICH Q11
Stage B
ICH Q2
Stage B
ICH Q7
Stage B
ICH Q8
Stage B
Vaccine process technology

Jessica O. Josefsberg, Barry Buckland

Preclinical Safety

Stage A
The second Geneva Consensus: Recommendations for novel live TB vaccines

B.Walker, M.J.Brennan, M.M.Ho, J.Eskola, G.Thiry, J.Sadoff, R.Dobbelaer, L.Grode, M.A.Liu, U.Fruth, P.H.Lambert

Stage D
Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials

Ainhoa Arbues, Juan I. Aguilo, Jesus Gonzalo-Asensio, Dessislava Marinova, Santiago Uranga, Eugenia Puentes, Conchita Fernandez, Alberto Parra, Pere Joan Cardon, Cristina Vilaplana, Vicente Ausina, Ann Williams, SimonClark, Wladimir Malaga, Christophe Guilhot, Brigitte Gicquel, CarlosMartin

Preclinical Immunogenicity

Stage A
A multistage tuberculosis vaccine that confers efficient protection before and after exposure

Claus Aagaard, Truc Hoang, Jes Dietrich, Pere-Joan Cardona, Angelo Izzo, Gregory Dolganov, Gary K Schoolnik, Joseph P Cassidy, Rolf Billeskov & Peter Andersen

Stage A
Identification and Evaluation of Novel Protective Antigens for the Development of a Candidate Tuberculosis Subunit Vaccine

Elena Stylianou, Rachel Harrington-Kandt, Julia Beglov, Naomi Bull, Nawamin Pinpathomrat, Gwendolyn M. Swarbrick, Deborah A. Lewinsohn, David M. Lewinsohn, Helen McShane

Stage A
Mouse and Guinea Pig Models of Tuberculosis

Ian M Orme, Diane J Ordway

Stage C
A nonhuman primate toxicology and immunogenicity study evaluating aerosol delivery of AERAS-402/Ad35 vaccine

David A Hokey, Robert Wachholder, Patricia A Darrah, Diane L Bolton, Dan H Barouch, Krystal Hill, Veerabadran Dheenadhayalan, Stephan Schwander, C Steven Godin, Macaya Douoguih, Maria Grazia Pau, Robert A Seder, Mario Roederer, Jerald C Sadoff & Donata Sizemore

Stage C
GHVAP
Stage C
TRANSVAC

Preclinical Protection/Efficacy

Stage A
Animal Models of Tuberculosis: An Overview

Ann Williams, Ian M. Orme

Stage A
Animal models of tuberculosis: Lesson learnt

Amit Kumar Singh, Umesh D Gupta

Stage A
CTVD
Stage A
Comparative Analysis of Different Vaccine Constructs Expressing Defined Antigens from Mycobacterium tuberculosis

T. Mark Doherty, Anja W. Olsen, Joachim Weischenfeldt, Kris Huygen, Sushila D’Souza, Tatiana K. Kondratieva, Vladimir V. Yeremeev, Alexander S. Apt, Barbel Raupach, Leander Grode, Stefan Kaufmann, and Peter Andersen

Stage A
Evaluation of vaccines in the EU TB Vaccine Cluster using a guinea pig aerosol infection model of tuberculosis

Ann Williams, Graham J. Hatch, Simon O. Clark, Karen E. Gooch, Kim A. Hatch, Graham A. Hall, Kris Huygen, Tom H.M.Ottenhoff, Kees L.M.C.Franken, PeterAndersen, T.Mark Doherty, Stefan H.E.Kaufmann, LeanderGrode, PeterSeiler, CarlosMartin, Brigitte Gicquel, Stewart T.Cole, Priscille Brodin, Philip D.Marsh

Stage A
Experimental animal modelling for TB vaccine development

Pere-Joan Cardona, Ann Williams

Stage A
Identification and Evaluation of Novel Protective Antigens for the Development of a Candidate Tuberculosis Subunit Vaccine

Elena Stylianou, Rachel Harrington-Kandt, Julia Beglov, Naomi Bull, Nawamin Pinpathomrat, Gwendolyn M. Swarbrick, Deborah A. Lewinsohn, David M. Lewinsohn, Helen McShane

Stage A
The Protective Effect of the Mycobacterium bovis BCG Vaccine Is Increased by Coadministration with the Mycobacterium tuberculosis 72-Kilodalton Fusion Polyprotein Mtb72F in M. tuberculosis-Infected Guinea Pigs

Lise Brandt, Yasir A. W. Skeiky, Mark R. Alderson, Yves Lobet, Wilfried Dalemans, Oliver C. Turner, Randall J. Basaraba, Angelo A. Izzo, Todd M. Lasco, Philip L. Chapman, Steven G. Reed, Ian M. Orme

Stage C
Toward Tuberculosis Vaccine Development: Recommendations for Nonhuman Primate Study Design

Dominick J. Laddy, Aurelio Bonavia, Willem A. Hanekom, Deepak Kaushal, Ann Williams, Mario Roederer, Robert A. Seder, Sally Sharpe, Frank A. W. Verreck, Patricia A. Darrah

Clinical Development And Operations

Stage B
Innovative clinical trial designs to rationalize TB vaccine development

R.D.Ellis, M.Hatherill. D.Tait, M.Snowden, G.Churchyard, W.Hanekom, T.Evans, A.M.Ginsberg

Stage E
Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination

Elisa Nemes, Ph.D., Hennie Geldenhuys, M.B., Ch.B., Virginie Rozot, Ph.D., Kathryn T. Rutkowski, M.Sc., Frances Ratangee, B.N., Nicole Bilek, Ph.D., Simbarashe Mabwe, M.Sc., Lebohang Makhethe, B.Sc., Mzwandile Erasmus, B.Sc., Asma Toefy, B.Sc., Humphrey Mulenga, M.P.H., Willem A. Hanekom, M.B., Ch.B., et al., for the C-040-404 Study Team

Clinical Efficacy

Stage E
Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries

Gwenan M. Knight, Ulla K. Griffiths, Tom Sumner, Yoko V. Laurence, Adrian Gheorghe, Anna Vassall, Philippe Glaziou, and Richard G. White

Market Access

Stage G
Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries

Gwenan M. Knight, Ulla K. Griffiths, Tom Sumner, Yoko V. Laurence, Adrian Gheorghe, Anna Vassall, Philippe Glaziou and Richard G. White

Resource 
SAGE report BCG
Resource 
WHO PPC for Therapeutic vaccines – Preferred product characteristics for therapeutic vaccines to improve tuberculosis treatment outcomes: Key considerations from World Health Organization consultations

Johan Vekemans, Michael James Brennan, Mark Hatherill, Lewis Schrager, Bernard Fritzell, Kathryn Rutkowski, Beatrice De Vos, Matteo Zignol, Georges Thiry, Ann M. Ginsberg, Barry Walker