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CEPI Centralized Clinical Laboratory Network at UVRI: Advancing Global Vaccine Preparedness

In a world where emerging infectious diseases pose ever-present threats to public health, the Uganda Virus Research Institute (UVRI) stands as a beacon of readiness and scientific excellence. Through its critical partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) Centralized Clinical Laboratory Network (CLN), UVRI is at the forefront of standardized immunological testing and vaccine immunogenicity assessments. This collaboration is dedicated to ensuring that vaccines for viral threats—whether known pathogens like Ebola, Marburg, and Mpox, or future, yet-unknown diseases such as "Disease X"—are rigorously evaluated, fast-tracked for development, and prepared for rapid deployment to protect populations worldwide.

At the heart of UVRI's mission within CEPI's CLN lies a commitment to standardization, accuracy, and agility. Leveraging state-of-the-art infrastructure and decades of scientific expertise, UVRI processes and tests specimens from clinical trials and outbreak survivors across diverse regions. These efforts generate reliable, high-quality data essential for accelerating the global development and licensure of life-saving vaccines. UVRI's adaptive five-year framework ensures the institute remains responsive to emerging challenges, poised to integrate new technologies and expand capacities as pandemic threats evolve.

Through this initiative, UVRI not only enhances global epidemic preparedness but also contributes to regional capacity building and technology transfer. By training scientists, optimizing assays, and fostering collaborations, UVRI strengthens the ability of Africa and the world to confront future viral threats swiftly and effectively. Together with CEPI, UVRI is driving the global mission to ensure that no future epidemic catches us unprepared.

 

Goal of CEPI: Strengthening Global Health Security Through Vaccine Innovation

CEPI's mission is to accelerate the development of vaccines against emerging and re-emerging infectious diseases, safeguarding the world from potential epidemic and pandemic threats. Through the creation and support of the Centralized Clinical Laboratory Network (CLN), CEPI ensures standardized, high-quality immunological testing and assay validation, fostering global collaboration and preparedness. In alignment with the ambitious “100 Days Mission,” CEPI aims to reduce vaccine development timelines to just 100 days, revolutionizing rapid responses to new and evolving pathogens, including the anticipated “Disease X.” By partnering with strategic hubs like Uganda Virus Research Institute (UVRI), CEPI builds regional and global capacities, supports technology transfer, and ensures equitable access to cutting-edge tools for combating viral epidemics. Together, these initiatives fortify global health security, ensuring that communities worldwide are protected through innovation, collaboration, and proactive epidemic preparedness.

Specific Objectives of CEPI's Centralized Clinical Laboratory Network (CLN)

1. Accelerate Vaccine Development Timelines
   • Support CEPI’s ambitious "100 Days Mission" to develop vaccines against emerging infectious diseases within 100 days.
   • Facilitate rapid identification and evaluation of the most promising vaccine candidates through standardized and reliable immunogenicity testing.
2. Standardize Assay Development and Validation
   • Harmonize immunological assay protocols across a global network to ensure consistency, accuracy, and comparability of vaccine efficacy data.
   • Establish and qualify assays such as ELISA, ELISpot, neutralization assays, flow cytometry, Luminex multiplex serology, and Meso Scale Discovery (MSD) platforms for robust vaccine immunogenicity assessment.
3. Strengthen Global Health Security
   • Enhance global preparedness for epidemic and pandemic threats, including potential “Disease X,” by maintaining a responsive and adaptive testing infrastructure.
   • Support rapid response to emerging viral outbreaks through the timely assessment of vaccine candidates.
4. Expand Testing Capacity in the Global South
   • Increase the geographic reach and capacity of immunological and molecular testing by integrating key laboratories in the Global South, such as UVRI, into the CEPI CLN.
   • Minimize sample transfer delays by establishing regional testing hubs, thereby accelerating vaccine assessments and licensure.
5. Enhance Regional Outbreak Preparedness and Response
   • Empower regional laboratories like UVRI with cutting-edge technologies and expertise to support local and regional outbreak response.
   • Facilitate the collection, analysis, and dissemination of immunogenicity data to inform public health interventions and vaccine deployment strategies.
6. Promote Technology Transfer and Capacity Building
   • Foster the transfer of advanced immunological testing technologies to regional partners.
   • Provide ongoing training, capacity building, and mentorship to strengthen laboratory capabilities in emerging and re-emerging infectious diseases.
7. Ensure Data Integrity and Quality Assurance
   • Implement rigorous quality assurance and quality control (QA/QC) protocols, including participation in external quality assessments (EQAs) and adherence to Good Clinical and Laboratory Practices (GCLP).
   • Guarantee high-quality, reliable data to support vaccine licensure and global health decision-making.
8. Facilitate Collaborative Research and Innovation
   • Strengthen global collaboration by integrating research sites and laboratories within the CEPI CLN framework.
   • Encourage multi-institutional partnerships to advance vaccine research, discovery, and immunogenicity testing.
9. Support Ethical and Compliant Research Practices
   • Ensure that all testing is conducted with full ethical compliance, including appropriate informed consent, participant confidentiality, and adherence to national and international regulations.
   • Uphold principles of transparency, data ownership, and responsible reporting of findings.
10. Advance Global Vaccine Equity
11. • Contribute to the equitable distribution and evaluation of vaccines by providing timely and standardized data to inform global vaccine strategies.
    • Support vaccine access and readiness in regions most vulnerable to emerging infectious diseases.

Key Activities

1. Standardized Immunogenicity Testing:
• UVRI conducts rigorous, standardized testing of vaccine candidates for priority diseases, including Ebola, Marburg, Lassa, Nipah, Rift Valley Fever, SARS-CoV-2, Mpox, and unidentified emerging threats.
• Utilizing validated assays such as ELISA, ELISpot, flow cytometry, Luminex serology, and pseudovirus neutralization assays, UVRI ensures high-quality, consistent data across clinical trials globally.
2. Assay Development, Validation, and Optimization:
• UVRI develops and optimizes cutting-edge assays for vaccine trials and outbreak responses.
• Ensures assay validation to CEPI’s standards, facilitating rapid and accurate immunogenicity assessments critical for vaccine licensure.
3. Capacity Building and Technology Transfer:
• UVRI strengthens regional capabilities by transferring advanced technologies, such as Genomic characterisation and immun profiling.
• Provides comprehensive training and mentorship to enhance outbreak preparedness and vaccine research capacity in East and Central Africa.
4. Supporting Clinical Trials and Outbreak Response:
• As a central testing hub, UVRI processes specimens from clinical trials and survivor cohorts across diverse regions, adhering to stringent biohazard containment and safety protocols.
• Facilitates rapid data generation to inform vaccine efficacy and accelerate development timelines in alignment with CEPI's 100 Days Mission.
5. Quality Assurance and Data Integrity:
• Implements Good Clinical and Laboratory Practice (GCLP) standards, participates in external quality assessments, and conducts regular audits to ensure data integrity and reliability.
• Manages secure, confidential data handling to support global vaccine research efforts.
6. Global Health Impact:
• Contributes to the development of vaccines that protect vulnerable populations against epidemic and pandemic threats.
• Positions UVRI as a leader in global epidemic preparedness through collaborative research, standardized protocols, and high-impact immunological assessments.

Recent Impact /Achievements by the department/unit/project

The Coalition for Epidemic Preparedness Innovations (CEPI) Centralized Clinical Laboratory Network (CLN) at the Uganda Virus Research Institute (UVRI) plays a pivotal role in strengthening global health security through standardized molecular and immunogenicity testing, assay development, and validation. This collaboration positions UVRI as a critical hub for accelerating vaccine development timelines and enhancing regional outbreak preparedness, in line with CEPI's "100 Days Mission" to fast-track vaccine development against emerging and re-emerging infectious diseases.

Impact and Achievements

1. Molecular Diagnostics for the Mpox SMART Trial in the DRC

In response to the Mpox outbreak in the Democratic Republic of Congo (DRC), UVRI will contribute molecular diagnostics to the Mpox SMART (Smallpox vaccine for Mpox post-exposure prophylaxis) trial. This initiative supports accurate detection and monitoring of Mpox cases, providing essential data to guide clinical trials and public health interventions in the region.

2. Ebola and Marburg Assay Development and Optimization

UVRI is instrumental in developing and optimizing critical assays for the detection of immune responses against Ebola and Marburg viruses. These assays are essential for evaluating vaccine candidates and supporting clinical trials aimed at preventing these highly lethal diseases. The rigorous validation of these assays will ensure high-quality, reliable data that inform vaccine licensure and deployment strategies.

3. Immunogenicity Assessments for Mpox Vaccine Trials

As part of CEPI's CLN, UVRI has conducted comprehensive immunogenicity assessments for Mpox vaccine trials. By applying validated immunological assays, UVRI ensures that vaccine candidates are evaluated for their effectiveness in generating protective immune responses. This work supports the development of vaccines that can mitigate future Mpox outbreaks.

4. Specimen Collection for Assay Standardization and Vaccine Development

UVRI facilitates the collection and processing of specimens from diverse regions, including clinical trial participants and survivors of viral outbreaks. These specimens are crucial for the standardization of immunogenicity assays and for advancing the development of vaccines against priority diseases such as Lassa fever, Rift Valley fever, Nipah virus, and potential "Disease X" pathogens.

5. Mpox Outbreak Investigation and Serological Detection Optimization

During ongoing Mpox outbreaks, UVRI contributes to the investigation and optimized serological detection methodologies. These efforts enhance the accuracy and speed of identifying Mpox cases, improving outbreak response capabilities and informing public health strategies.

Major Funders

The Coalition for Epidemic Preparedness Innovations (CEPI) is funded by a diverse group of public, private, philanthropic, and international organizations. These funders include:

Government Funders

1. United Kingdom – Department of Health and Social Care (DHSC)
2. Norway – Norwegian Ministry of Foreign Affairs
3. Germany – Federal Ministry of Education and Research (BMBF)
4. Japan – Ministry of Health, Labour and Welfare (MHLW)
5. Australia – Department of Foreign Affairs and Trade (DFAT)
6. Canada – Global Affairs Canada
7. United States – Department of Health and Human Services (HHS)
8. European Union – European Commission (EC)
9. India – Department of Biotechnology
10. Saudi Arabia – King Salman Humanitarian Aid and Relief Center
11. Sweden – Ministry of Health and Social Affairs
12. Finland – Ministry for Foreign Affairs
13. Austria – Federal Ministry of Education, Science and Research

Philanthropic Funders

1. Bill & Melinda Gates Foundation
2. Wellcome Trust

Private Sector Funders

1. Microsoft
2. Visa Foundation
3. Nippon Telegraph and Telephone Corporation (NTT)

International Organizations

1. World Health Organization (WHO)
2. Gavi, the Vaccine Alliance

Other Contributors

• CEPI also receives contributions from other organizations, NGOs, and consortia focused on global health and pandemic preparedness.