Terms of the TB Vaccines Pipeline
The Working Group on New TB Vaccines (WGNV) compiles a pipeline of tuberculosis (TB) vaccine candidates for use in humans, for both preventive and therapeutic indications (“Pipeline”). Vaccines being developed for veterinary use are not included in this Pipeline.
1. Sources of Information and Updates
Information in this Pipeline is reported by vaccine sponsors/lead developers or is found in a clinical trial registry or other public source of information. The Pipeline will be updated annually though outreach by WGNV to vaccine sponsors/lead developers. It may also be updated if a sponsor/lead developer voluntarily notifies WGNV of a change in a candidate’s development status or if WGNV becomes aware of a candidate’s status change through a clinical trial registry or other publicly available information.
The source of information for each candidate and the date most recently updated are indicated in the detailed candidate information page (found by clicking the candidate name in the online Pipeline).
2. Criteria for Inclusion and Designation of Stage/Phase
The Pipeline is compiling information on TB vaccine candidates from proof-of-concept in animal models through to phase 4 post-licensure studies. The stages of development in the Pipeline align with the stages of development outlined in the TB Vaccine Development Pathway, which provides a proposed structured development path and suggested gating criteria and describes the different functions and capabilities typically required to advance a candidate TB vaccine to its next stage of development. Exceptions to this Pipeline alignment may be made in the case of licensed products being studied for public health and policy information purposes.
2.1 Preclinical Development
Candidates in the preclinical stage comprise the following two stages of development.
- Proof-of-concept in animal models – the candidate has demonstrated protection and immunogenicity in at least one animal model, demonstrated by at least one article published in a peer-reviewed journal (Stage B)
- Preclinical evaluation (Stage C)
- Preparation for entry into first clinical trials, including GMP and toxicology studies and preparing the clinical trial application (Stage D)
Information about immune responses, immune tissue localization, and trained immunity for preclinical vaccine candidates are categorized as follows:
Hypothesized. This is the predicted or intended immune response for this candidate, but it has not yet been experimentally demonstrated.
Demonstrated. The predicted or intended immune response has been experimentally demonstrated.
Preclinical candidates will be included in the Pipeline if there is research actively being conducted on the candidate or research activities have been conducted on the candidate within the past five years and there are plans to continue research on the candidate. Candidates for which there has been no active research activity in the past five years or for which no updates have been received from the developer will be removed from the Pipeline.
2.2 Clinical Development
Candidates in clinical development are categorized by latest phase of clinical development, based on active or completed clinical trials. The following criteria must be met for a clinical trial to be included in the Pipeline:
- The trial sponsor must have sufficient funding committed to complete the trial;
- The protocol must have received applicable regulatory authority and ethics committee approvals; and
- The trial must be registered in a recognized national or international clinical trial database
Other organizations that publish TB vaccine pipelines may use different criteria to categorize phase of development, and their pipelines may therefore differ from the WGNV Pipeline.
Recognizing that there are delays between clinical trials, vaccine candidates that are not currently in active trials will continue to be listed in the Pipeline for up to five years after completion of the latest trial unless the vaccine sponsor informs WGNV that the candidate is no longer in active development. If the candidate has not advanced after five years or updates have not been provided by the sponsor, the candidate will be removed from the Pipeline.
The following definitions are used for the Pipeline:
Platform. Platform refers to the type of vaccine, based on how it is structured and how it produces an immune response in the body.
Vaccine Sponsor/Lead Developer. The institution that is leading the development of a vaccine candidate and owns the intellectual property or holds a license for further development of a vaccine candidate.
Development Partners. Institution(s) with whom the Sponsor/Lead Developer is partnering for the development of the vaccine candidate, including clinical trial sponsors, manufacturing partners, and/or vaccine authorization holders.
Clinical Trial Sponsor: An organization that is responsible for a clinical trial. This may be but is not necessarily the Vaccine Sponsor or Lead Developer of the vaccine candidate.
Indication(s). The specific goal(s) the vaccine candidate has been designed to achieve, such as prevention of disease, prevention of Mycobacterium tuberculosis (Mtb) infection, prevention of TB recurrence, or shortening duration of treatment. The Pipeline separates the indication(s) by primary – the main goal(s) – the vaccine is designed to achieve; and other indication(s).
Target Population(s). The populations for which the vaccine is being developed, including different age groups (for example, infants, adolescents, and/or adults); people with Mtb infection or people who are not infected with Mtb, and people living with HIV.
Immunological response: The hypothesized or demonstrated immune response produced by the body when exposed to a pathogen such as Mtb. T-cells and B-cells and/or the cytokines or antibodies, respectively, they produce are the most commonly measured immunological responses in TB vaccine development.
Active (clinical trial status): Participants are being actively recruited for a clinical trial or follow-up visits are being conducted. Clinical trials that are preparing for recruitment may be listed as active if they meet the criteria mentioned in Section 2.2.
Completed (clinical trial status): Participants are no longer being recruited and all follow-up visits have been conducted.
Primary endpoint(s)/objective(s) for clinical trial: The primary measure and outcome that the trial sponsor is seeking in this trial, as listed in the clinical trial registry. Secondary endpoint(s)/objective(s) are not listed in this Pipeline but can be found in the clinical trial registry listing.
Target population(s) for clinical trial: The population groups that are being recruited for this trial. This includes the age group for the trial as well as any other specific population criteria.
4. Sortable Pipelines
The Preclinical and Clinical Pipelines can be sorted by stage or phase of development, platform, whether the candidate is in an active clinical trial (Clinical Pipeline only), target indication(s), target population(s), and route of administration by clicking on the “Sortable Pipeline” button on the online Pipeline. The Preclinical Pipeline can be further sorted by immunological response, immune tissue localization, animal models in which the candidate has been tested, and whether the candidate is intended to elicit trained immunity. Please note that information in the Sortable Pipelines is included for a vaccine candidate if this information has been provided by the Vaccine Sponsor or Lead Developer. If this information has not been provided, the candidate will not appear in these filters.
5. Downloadable Pipeline Images
Downloadable PowerPoint slides are available for public use, showing vaccine candidates in clinical development by latest phase of development and vaccine candidates in active clinical trials.
Preclinical candidates will be included in this or a separate downloadable image as that information becomes available.
The TB Vaccine Pipeline (“Pipeline”) is provided for informational purposes. The information used in this Pipeline (“Information”) was reported by the Vaccine Sponsor, Lead Developer, Clinical Trial Sponsor, or found in the public domain associated with the specific candidate and should be considered “as is.” The Stop TB Partnership Working Group on New TB Vaccines does not guarantee or warrant the accuracy, completeness, or reliability of any of the Information displayed in this Pipeline. Use of any such Information, for whatever purpose, shall be at the user’s own risk and liability.
26 January 2024