Back
References TB Vaccine Development Pathway

Introduction

The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development - ScienceDirect
Systematic review of mathematical models exploring the epidemiological impact of future TB vaccines
WHO Preferred Product Characteristics for New Tuberculosis Vaccines
WHO Report on BCG vaccine use
Therapeutic_TB_Vaccination_WHO_PPC_for_public_review

Function 1: Project Management

Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles
FDA Guidance
UK MRC guidance
BCG SSI
BCG SII
BCG Tice
WHO PPC for New TB Vaccines

Function 3: Product Characterisation and Quality

New live mycobacterial vaccines: the Geneva consensus on essential steps towards clinical development
The second Geneva Consensus: Recommendations for novel live TB vaccines
ICH Q8
ICH Q11
ICH Q2
Guideline on quality aspects included in the product information for vaccines for human use (18 October 2018; EMA/CHMP/BWP/133540/2017

Function 4: Production Process

ICH Q7
ICH Q8
ICH Q11
ICH Q2
Vaccine process technology
EMA guidelines on adjuvant in vaccines
Quality aspects on quality, non-clinical and clinical aspects of live viral vectored vaccines
Liposome Drug Products FDA Guidance
Josefsberg and Buckland 2012
N. Garçon, M. Friede, Evolution of Adjuvants Across the Centuries, Chapter 6, pp 61-74, in S.A. Plotkin, P.A. Offit, W.A. Orenstein, K.M. Edwards (eds), Vaccines, 7th edition, Elsevier 2018
S.S. Ahmed, R.W. Ellis, Rino Rappuoli, Technologies for Making New Vaccines, chapter 66, pp.1283-1304, in Plotkin 7th ed.
D.B. Weiner, G.J. Nabel, Development of Gene-Based Vectors for Immunization, chapter 67, pp 1305-1319, in Plotkin 7th ed.
WHO recommendations BCG vaccines, 2013

Function 5: Preclinical Safety

WHO Recommendations
WHO guidelines on non-clinical evaluation of vaccines. WHO Technical report series No927, 2005
FDA/CBER Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, 11/2007
WHO Technical Report Series No 941, 2007
EMA/CHMP/VWP/141697/2009
The second Geneva Consensus: Recommendations for novel live TB vaccines
Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials
FDA

Function 6: Preclinical Immunogenicity

Mouse and Guinea Pig Models of Tuberculosis
Identification and Evaluation of Novel Protective Antigens for the Development of a Candidate Tuberculosis Subunit Vaccine
A multistage tuberculosis vaccine that confers efficient protection before and after exposure
A nonhuman primate toxicology and immunogenicity study evaluating aerosol delivery of AERAS-402/Ad35 vaccine
GHVAP
TRANSVAC

Function 7: Preclinical Protection/Efficacy

Experimental animal modelling for TB vaccine development
Animal models of tuberculosis: Lesson learnt
Animal Models of Tuberculosis: An Overview
Identification and Evaluation of Novel Protective Antigens for the Development of a Candidate Tuberculosis Subunit Vaccine
Comparative Analysis of Different Vaccine Constructs Expressing Defined Antigens from Mycobacterium tuberculosis
Tuberculosis vaccine development; from mouse to man
Evaluation of vaccines in the EU TB Vaccine Cluster using a guinea pig aerosol infection model of tuberculosis
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
Revaccination of Guinea Pigs With the Live Attenuated Mycobacterium tuberculosis Vaccine MTBVAC Improves BCG's Protection Against Tuberculosis
TBVI services
CTVD
NIAID/NIH pre-clinical models
Toward Tuberculosis Vaccine Development: Recommendations for Nonhuman Primate Study Design

Function 8: Regulatory

A regulatory plan for TB vaccines – points to consider
World Health Organization (WHO)
AVAREF
Africa Network
Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes
GAVI, the Vaccine Alliance
WHO prequalification
WHO guidelines on the non-clinical evaluation of vaccine adjuvants and adjuvanted vaccines, 2013
WHO Guidelines for assessing the quality, safety and safety of DNA vaccines
FDA Guidance for Industry, Considerations for plasmid DNA vaccines for infectious disease indications, Nov 2007
EMA/CHMP/VWP/141697/2009, Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines
Liposome containing vaccines: Liposome drug products, FDA Guidance for Industry, April 2018
The second Geneva Consensus meeting
US Pharmacopeia (USP)
WHO recommendations on BCG vaccines
SRA
CCDS information
ICHE2E: Guideline on Pharmacovigilance Planning
EDQM
CBER batch release
CTD
ICH M2 EWG
Model insert BCG vaccine
WHO/IVB/05.23

Function 9: Clinical Development and Operations

Innovative clinical trial designs to rationalize TB vaccine development
Good Participatory Guidelines for TB Vaccines
Study synopsis
Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination

Function 12: Clinical Efficacy

WHO definitions of TB 2014
Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries
WHO PPC for New TB Vaccines

Function 13: Market, Access and Implementation

WHO PPC for New TB Vaccines
SAGE report BCG
WHO PPC for Therapeutic vaccines – Preferred product characteristics for therapeutic vaccines to improve tuberculosis treatment outcomes: Key considerations from World Health Organization consultations
Vaccines Europe
Impact and cost-effectiveness of new tuberculosis vaccines in low- and middle-income countries
GAVI vaccine investment strategy

About

Rational approach to selection and clinical development of TB vaccine candidates
The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development