Preclinical Pipeline Submission Form

Use this form to submit information about candidates in preclinical development.

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. The stage gates associated with phases of development are noted on this form.

By submitting information through this platform, you agree to have the information shared for public viewing and public use. Please do not submit confidential information or information that is not yet available for the public.

TB Vaccine Preclinical Candidate Submission Form

"*" indicates required fields

Please indicate if this is a new submission or an update for a vaccine candidate previously submitted*

New submission

Update for candidate previously submitted

Vaccine Candidate Information

Vaccine Candidate Name*

Vaccine Description (Required for new submissions)

Provide a brief description of the vaccine candidate (limit 400 characters), including vaccine platform, antigens expressed, adjuvant, and formulation, as relevant. Please do not summarize research and/or trial results in this section.

Lead vaccine development institution*

Vaccine development partner(s) (if applicable)

Type of Vaccine (required for new submissions)

RNA

Mycobacterial - Inactivated

Mycobacterial - Live attenuated

Protein/Adjuvant

Viral Vector

Other

Stage of Development (required for new submissions)

Please indicate the stage of development of this vaccine candidate. If a candidate is in more than one stage, indicate the latest stage of development. If the candidate is in human clinical trials, please complete the TB Vaccine Clinical Candidate Submission Form.

Proof of concept in animal model(s) - candidate has demonstrated protection and immunogenicity in at least one animal model (Stage B)

Preclinical evaluation (Stage C)

Preparation for First-in-Human Ph 1 (Stage D)

Other

What is the primary target indication for this vaccine candidate? (required for new submissions)

Prevention of Mtb infection or sustained infection

Prevention of TB disease

Prevention of TB recurrence

Immunotherapy/Shortening TB treatment

Immunotherapy/Improving TB cure rates

To be determined

Other

Indicate any additional indication(s) for this vaccine candidate (check all that apply)

Prevention of Mtb infection or sustained infection

Prevention of TB disease

Prevention of TB recurrence

Immunotherapy / Shortening TB treatment

Immunotheraphy / Improving TB cure rates

Other (please specify)

Other target indication(s)

Please indicate the target population(s) for the vaccine candidate (check all that apply) (required for new submissions)

Adults

Adolescents

Children

Infants

Elderly

People with MDR-TB

People with Mtb infection

People without Mtb infection

People with active TB

People cured of active TB

People living with HIV

Other

To be determined

Other target population(s)

What is the target route of administration for this vaccine candidate?

Aerosol

Intradermal

Intramuscular

Intranasal

Subcutaneous

To be determined

Other

Preclinical Candidate Information

Is research currently being conducted on this vaccine candidate?

Yes

If research is not currently being conducted, has there been research activity on this candidate in the past five years?

Yes

If research is not currently being conducted on this candidate, are there plans to continue to conduct research on this candidate in the future?

Yes

Please provide a brief description of future plans for this vaccine candidate

In which animal model(s) has this vaccine candidate been tested? (Check all that apply)

Cow

Ferret

Guinea pig

Mouse

Nonhuman primate

Rabbit

Other

Please specify other animal model(s)

Are the results published?

Yes

Publication(s)

If the results of testing in animal model(s) are published, please upload the publication(s) here.

Drop files here or

Accepted file types: pdf, Max. file size: 300 MB, Max. files: 5.

What is the predicted/hypothesized target immunological response this vaccine candidate is intended to generate?

B-cell/Antibody

T-cell

Other

Please specify other intended immunological response

What are the characteristics of the intended B-cell/antibody response? (optional)

What is the predicted/intended T-cell phenotype? (Check all that apply)

CD4

CD8

Gamma-delta (γδ)

Natural Killer (NK)

CD1

HLA-E

MR1

Other

Please specify other predicted/intended T-cell phenotype

What is the predicted/intended T-cell functional profile? (Check all that apply)

IFN-γ

TNF-α

IL-17

Cytolytic Capacity

Polycytotoxicity

Mycobacterial growth inhibition

Other

Please specify other predicted/intended T-cell functional profile

What immunological response has been experimentally demonstrated for this vaccine candidate? (Check all that apply)

B-cell/Antibody

T-cell

Other

What are the characteristics of the demonstrated B-cell response?

Please specify other demonstrated immunological response

What T-cell phenotype has been experimentally demonstrated? (Check all that apply)

CD4

CD8

Gamma-delta (γδ)

Natural Killer (NK)

CD1

HLA-E

MR1

Other

Please specify other demonstrated T-cell phenotype

What T-cell functional profile has been experimentally demonstrated? (Check all that apply)

IFN-γ

TNF-α

IL-17

Cytolytic Capacity

Polycytotoxicity

Mycobacterial growth inhibition

Other

Please specify other validated demonstrated profile

What is the intended preferential immune tissue localization of this vaccine candidate?

Gut

Lung

Lymph node

Skin

Other

Specify other preferential tissue localization

What immune tissue localization has been experimentally demonstrated?

Gut

Lung

Lymph node

Skin

Other

Please indicate other demonstrated tissue localization

Is this vaccine candidate intended to elicit trained immunity?

Yes

Has trained immunity been experimentally demonstrated?

Yes

Publications

Please provide links or PDFs of publications of data validating immune responses, tissue localization, trained immunity, clinical research findings or other research data and findings about this candidate.

Weblinks

https://

Uploads

You do not need to upload articles if weblinks are already provided above.

Drop files here or

Accepted file types: pdf, Max. file size: 10 MB, Max. files: 5.

Other Information (Optional)

Other Information

If you have other information you would like to share about this candidate, please enter it here.

Submitter Information

Submitter Name*

First Last

Institution*

Submitter Email*

Enter Email Confirm Email

Date Submitted*

MM slash DD slash YYYY

Authorization*

I confirm that I am authorized to submit this form on behalf of the vaccine sponsor/lead vaccine development institution for this vaccine candidate

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Newsletters

I would like to receive information about becoming involved in the Stop TB Partnership Working Group on New TB Vaccines.

I would like to receive periodic email updates about TB vaccine R&D from the Working Group on New TB Vaccines.

Consent*

I consent

By checking this box, you consent to the storage and use of your information by IAVI and the Working Group on New TB Vaccines (WGNV), to verify your information and contact you in connection with your submission and the WGNV Program. All information will be stored and used in compliance with our Privacy Policy

Please confirm that all information is correct before submitting.

Preclinical Pipeline Submission Form

TB Vaccine Preclinical Candidate Submission Form

Vaccine Candidate Information

Preclinical Candidate Information

Publications

Other Information (Optional)

Submitter Information

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Useful Links

About WGNV

Our Priorities

TB Vaccine Pipeline

Resources

Become a Member

Take Action