TBVI

What TBVI does

TuBerculosis Vaccine Initiative (TBVI) is a non-profit foundation established in 2015 and headquartered in Lelystad, Netherlands, that facilitates the discovery and development of new, safe, and effective tuberculosis vaccines through partnership coordination rather than direct laboratory work. The organization functions as a Product Development Partnership, identifying and coordinating TB vaccine research projects, facilitating knowledge exchange through scientific meetings and publications, and advocating for increased global investment in TB vaccine R&D. TBVI coordinates two major multi-partner consortia: the TBVAC-HORIZON project (19 partners, Horizon Europe funded, April 2023 to March 2027) focused on lung immunity and mucosal TB vaccine pipelines, and the MTBVAC AVANTE consortium (12 partners, €18.2 million from Global Health EDCTP3 against a €74.8 million total budget, running through April 2030) advancing the MTBVAC vaccine candidate through Phase 2b and Phase 3 clinical trials across sub-Saharan Africa.

TBVI's core products are research coordination services and consortium facilitation programs rather than commercial vaccines. The underlying technology TBVI helps advance is MTBVAC, the only TB vaccine candidate currently in clinical trials based on an attenuated form of Mycobacterium tuberculosis, originally designed by researchers at University of Zaragoza and Institut Pasteur and industrially developed by Biofabri (part of Spain's Zendal Group). TBVI has also facilitated selection of 10 early-stage TB vaccine candidates for head-to-head testing under TBVAC-HORIZON. The foundation operates with a small leadership team of approximately 13 professionals, including figures with prior senior R&D roles at Pfizer Vaccines, GSK Vaccines, and the European Commission.

TBVI's business model is grant-based rather than commercial. The organization receives project funding from public sources including the European Union (Horizon Europe, EDCTP3, EU4Health via HaDEA), UK Research and Innovation, and the Swiss State Secretariat for Education, Research and Innovation. Revenue is not publicly disclosed, and there are no commercial sales. Customer segments are effectively the global TB vaccine research community: academic institutions, research organizations, clinical trial centers in sub-Saharan Africa, and regional manufacturing partners in India (Bharat Biotech) and Brazil (Fundação Ataulpho de Paiva) for downstream equitable access. The TBVI Annual Symposium in Les Diablerets, Switzerland, attended by over 115-120 researchers, developers, funders, and policymakers from up to 20 countries, serves as the primary convening channel for the network.

Name

TBVI

Legal name

TuBerculosis Vaccine Initiative

Website

https://tbvi.eu

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

TuBerculosis Vaccine Initiative (TBVI) is a Netherlands-based non-profit foundation that coordinates global TB vaccine R&D partnerships, managing major EU-funded consortia advancing vaccine candidates like MTBVAC through clinical trials in sub-Saharan Africa.

Ownership category

akta.pro rank

Product category

Vaccine Research & Development

NAICS

Scientific Research and Development Services (5417), Voluntary Health Organizations (813212)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Disease-Specific Global Initiatives (HIV/TB/Malaria/NTDs) (HLAJAOAE)

akta.pro secondary industries

Immunization & Vaccine Access Partnerships (Global Vaccine Alliances) (HLAJAOAF), Clinical Development & Regulatory for Vaccines (trials, pharmacovigilance, lot release) (HLAAAEAK), Global Health Research, Evidence & Technical Assistance Organizations (HLAJAKAN)

Keywords

• TB vaccine research
• Vaccine clinical development
• Research consortium coordination
• Global health partnerships
• Vaccine R&D facilitation

Headquarters

HQ city

Lelystad

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Project-based Grant Funding: TBVI operates as a non-profit foundation funded through public and private project grants from organizations including EU Horizon Europe, EDCTP3, and Global Health EDCTP3. The organization receives funding to coordinate and facilitate TB vaccine research and development partnerships.

Distribution channels2 records

Marketing channels5 records

Core offering

TBVI is a non-profit foundation that facilitates the discovery and development of new, safe and effective tuberculosis (TB) vaccines by identifying, developing and coordinating research projects, facilitating knowledge exchange through scientific meetings, publications, and networking, and providing technical inputs for evidence-based advocacy. The organization coordinates multi-partner consortia such as TBVAC-HORIZON (19 partners, lung immunity and mucosal vaccine pipeline) and MTBVAC AVANTE (12 partners, Phase 2b/3 clinical development of the MTBVAC vaccine candidate). TBVI does not commercialize vaccines directly but serves as a coordination and facilitation body connecting academic, industry, clinical, and funding partners.

Product overview

TBVI (TuBerculosis Vaccine Initiative) is a non-profit foundation that functions as a research and innovation partnership facilitating the discovery and development of new tuberculosis vaccines. Rather than manufacturing vaccines directly, TBVI serves as a coordination and facilitation body that identifies, develops and coordinates TB vaccine research projects; facilitates knowledge exchange through scientific meetings, publications, and networking; and advocates for increased TB vaccine R&D investment on the global agenda. TBVI's core offerings include research coordination services, the TBVAC-HORIZON consortium program (a Horizon Europe-funded four-year project with 19 partners focused on lung immunity and vaccine pipeline diversification), and facilitation of clinical development programs including MTBVAC AVANTE (supporting Phase 2b and Phase 3 trials of the MTBVAC vaccine candidate). The organization connects partners worldwide to create an enabling environment for TB vaccine research and product development with the ultimate goal of relieving the global burden of TB.

Differentiator

Problem solved

Functional benefit

Products and services

• TBVAC-HORIZON Research Program A four-year Horizon Europe-funded research project coordinated by TBVI (April 2023 – March 2027) that aims to improve understanding of lung immunity to tuberculosis infection and establish a diversified innovative TB vaccine pipeline targeting mucosal immunity. The consortium consists of 19 partners and includes work packages on immune protection mechanisms, mucosal vaccine delivery, biomarker assays, and GMP tools development. Ten early-stage TB vaccine candidates have been selected for head-to-head testing under this program.
• MTBVAC AVANTE Clinical Development Program A four-year international consortium program funded through April 2030 that advances the clinical development of MTBVAC, the only TB vaccine candidate based on an attenuated form of Mycobacterium tuberculosis currently in clinical trials. The program supports two major trials: the Phase 2b IMAGINE trial in adolescents and adults across South Africa, Kenya, and Tanzania, and the Phase 3 MTBVACN3 trial in newborns across South Africa, Madagascar, and Senegal. The consortium includes 12 partners from Europe and Africa.
• TBVI Research & Development Facilitation Services TBVI facilitates the discovery and development of new tuberculosis vaccines by identifying, developing, and coordinating research projects; facilitating knowledge exchange through scientific meetings, publications, and networking; and providing technical inputs to advocate for increased TB vaccine R&D investment on the global agenda. The service connects partners from around the world to create an enabling environment for TB vaccine research and innovation, with the ultimate goal to relieve the burden of TB.
• MTBVAC Phase 3 Clinical Trial Support TBVI and Biofabri partnered with the European Health and Digital Executive Agency (HaDEA) under the EU4Health Programme to accelerate the final stages of MTBVAC clinical development. This supports a Phase 3 clinical trial in neonates evaluating protective efficacy, safety, and immunogenicity in HIV-unexposed and HIV-exposed populations across African countries.

Quantifiable outcome

• Over 79 million lives saved since 2000 through global TB efforts (referenced in context)
• +1 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

19 partnerships are on record, tiered core and secondary.

• MTBVAC AVANTE Consortium (12 partners)coreStrategic or Co-development Partner · 4 June 2026The MTBVAC AVANTE consortium officially launched with €18.2 million funding from Global Health EDCTP3. The four-year program aims to advance clinical development of MTBVAC through ongoing trials in sub-Saharan Africa evaluating efficacy, safety, and immunogenicity in adolescents, adults, and newborns. Partners include Biofabri, IAVI, TBVI, IAVI Africa, IAVI South Africa, Enhancing Care Foundation, Ifakara Health Institute, SATVI, Universidad de Zaragoza, University of Cape Town, Wits Health Consortium, and Kenya Medical Research Institute.
• TBVAC-HORIZON Consortium (19 partners)coreStrategic or Co-development Partner · 1 April 2023TBVAC-HORIZON is a Horizon Europe funded project to improve understanding of lung immunity to TB infection and establish diversified innovative TB vaccine pipeline targeting mucosal immunity. Consortium includes TBVI (coordinator), BPRC, CNRS, UT3, INMI-IRCCS, Institut Pasteur, Institut Pasteur de Lille, LUMC, SSI, UNIZAR, UULM, CZ Vaccines, UNIBAS, VFI, UKHSA, LSHTM, MHRA, ULEIC, and UOXF. Project runs April 2023 - March 2027 with funding under grant agreement No 101080309.
• Biofabri (Zendal Group)coreStrategic or Co-development PartnerBiofabri is the lead coordinator and industrial developer of MTBVAC vaccine candidate. They are a Spanish biopharmaceutical company created in 2008 specializing in vaccine research, development, and manufacturing for humans, belonging to the Zendal Group.
• IAVIcoreStrategic or Co-development PartnerIAVI is a global nonprofit biomedical research organization with locations in the U.S., Europe, Africa, and India that develops vaccines and antibodies for HIV, TB, and emerging infectious diseases. IAVI sponsors the Phase 2b IMAGINE clinical trial and contributes clinical research expertise through their South Africa and Africa operations.
• Bharat Biotech International LimitedsecondaryStrategic or Co-development PartnerPartnership established with Bharat Biotech in India to facilitate regional manufacturing capacities for MTBVAC to ensure broad and equitable access if the vaccine proves safe and effective.
• Fundação Ataulpho de Paiva (FAP)secondaryStrategic or Co-development PartnerPartnership established with FAP in Brazil to facilitate regional manufacturing capacities for MTBVAC to ensure broad and equitable access if the vaccine proves safe and effective.
• South African Tuberculosis Vaccine Initiative (SATVI)coreStrategic or Co-development PartnerSATVI is a clinical trial partner conducting TB vaccine research at University of Cape Town with a 110-strong clinical and immunology laboratory research team. They have conducted 23 clinical trials of 9 novel TB vaccine candidates in over 3,000 participants.
• Ifakara Health InstitutecoreStrategic or Co-development PartnerClinical trial partner in Tanzania participating in MTBVAC AVANTE consortium for Phase 2b IMAGINE trial.
• Kenya Medical Research InstitutecoreStrategic or Co-development PartnerClinical trial partner in Kenya participating in MTBVAC AVANTE consortium for Phase 2b IMAGINE trial.
• University of ZaragozacoreTechnology or IntegrationUniversity of Zaragoza, led by Prof. Carlos Martin, designed the MTBVAC vaccine. The university continues as a partner in both MTBVAC AVANTE and TBVAC-HORIZON consortia.
• Institut PasteurcoreTechnology or IntegrationInstitut Pasteur, led by Prof. Brigitte Gicquel, co-designed the MTBVAC vaccine. Institut Pasteur also participates in TBVAC-HORIZON consortium through Roland Brosch's Integrated Mycobacterial Pathogenomics Unit.
• Vaccine Monitoring Collaboration for Europe (VAC4EU)secondaryStrategic or Co-development PartnerTBVI and EVI partnership with VAC4EU for collaborative fundraising efforts, knowledge sharing, and exploring opportunities to co-create and collaborate on topics of mutual interest in vaccine safety and benefit monitoring.
• Wits Health ConsortiumcoreStrategic or Co-development PartnerClinical trial partner in South Africa participating in MTBVAC AVANTE consortium for Phase 2b IMAGINE trial.
• University of Cape Town Lung InstitutecoreStrategic or Co-development PartnerClinical trial partner in South Africa participating in MTBVAC AVANTE consortium.
• Enhancing Care Foundation NPCcoreStrategic or Co-development PartnerClinical trial partner in South Africa participating in MTBVAC AVANTE consortium.
• Biomedical Primate Research Centre (BPRC)coreTechnology or IntegrationBPRC contributes to TBVAC-HORIZON through preclinical evaluation of new vaccines for TB in non-human primate models. Dr Frank Verreck leads the TB Research & Immunology programme.
• University of OxfordcoreStrategic or Co-development PartnerProf. Helen McShane serves as Chair of TBVAC-HORIZON's Translational Research. Oxford is conducting aligned clinical studies including the TB46 study with first participant enrolled April 2024.
• London School of Hygiene and Tropical Medicine (LSHTM)coreTechnology or IntegrationLSHTM participates in TBVAC-HORIZON with Prof. Hazel Dockrell leading immunology research on mycobacterial diseases.
• Statens Serum Institut (SSI)coreTechnology or IntegrationSSI participates in TBVAC-HORIZON with Dr Rasmus Mortensen leading TB Vaccine Research, focusing on protective mechanisms of vaccine mediated immunity.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Access to Advanced Health Institute (AAHI, formerly IDRI): Nonprofit biotech developing vaccines and immune therapies for infectious diseases including TB, with adjacent adjuvant and formulation capabilities. Operates in adjacent global health vaccine R&D space with comparable mission-driven, multi-disease approach.
• Medicines Development for Global Health: Non-profit pharmaceutical company developing medicines and vaccines for diseases of poverty using a partnership-driven model. Comparable to TBVI in being a mission-driven, grant-supported entity advancing neglected-disease product development through external manufacturing and clinical partners.

Others

• Biofabri (Zendal Group): Spanish biopharmaceutical company that is the industrial developer and lead coordinator of MTBVAC. While a commercial CDMO rather than a nonprofit, Biofabri is TBVI's closest vaccine development partner and counterpart in the MTBVAC program.

Broad incumbents

• PATH: Large global health nonprofit with vaccine, diagnostic, and device programs across multiple diseases. PATH operates a much broader portfolio than TBVI but shares the nonprofit, grant-funded, partnership-driven model for advancing vaccine access in low-resource settings.
• Gavi, the Vaccine Alliance: Public-private global health partnership that finances vaccine introduction and access in lower-income countries. While Gavi focuses on procurement and rollout rather than R&D, TBVI's regional manufacturing partnerships in India and Brazil are explicitly structured to enable future Gavi-eligible supply.

Direct peers

• International AIDS Vaccine Initiative (IAVI): Global nonprofit biomedical research organization developing vaccines and antibodies for HIV, TB, and emerging infectious diseases. IAVI is both a TBVI partner in MTBVAC AVANTE and a sponsor of the Phase 2b IMAGINE trial, operating a closely analogous product development partnership model.
• European Vaccine Initiative (EVI): European non-profit foundation coordinating vaccine R&D across multiple infectious disease indications with similar grant-funded, partnership-driven model. TBVI staff are seconded to EVI and they partner on fundraising with VAC4EU, indicating deep operational overlap.
• Coalition for Epidemic Preparedness Innovations (CEPI): Global partnership that coordinates funding and development of vaccines against epidemic threats, using a grant-funded, multi-stakeholder coordination model parallel to TBVI's. Both organizations serve as conveners and funders of late-stage vaccine clinical development across global networks.

Regional players

• South African Tuberculosis Vaccine Initiative (SATVI): Clinical trial partner at University of Cape Town with a 110-strong team and a track record of 23 clinical trials of 9 novel TB vaccine candidates in 3,000+ participants. Operates regionally in South Africa but is a leading TB vaccine clinical execution partner globally.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/tuberculosis-vaccine-inititive-tbvi-
• Xx.com/TBVI_EU

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about TBVI