COVID-19

IVI is partnering with vaccine developers around the world to accelerate multiple safe and effective vaccines as efficiently as possible. We are conducting early- and late-stage clinical trials, establishing vaccine evaluation systems and developing COVID-19 vaccine adjuvants in addition to epidemiological studies and other capacity-building activities.

IVI works throughout the value chain to enable our global partners in COVID-19 vaccine development

Pre-clinical studies for SARS-CoV-2 vaccine and therapeutics

IVI supported pre-clinical studies for developing SARS-CoV-2 vaccine and therapeutics using established vaccine evaluation systems.

Establishing the WHO international standard for SARS-CoV-2

IVI supported the establishment of the WHO international standard and reference panel for anti-SARS-CoV-2 antibody, essential for clinical sample analysis. This project was supported by CEPI.

 

Additionally, IVI also supported the Korea standard and reference panel for anti-SARS-CoV-2 antibody in collaboration with the Korea Disease Control and Prevention Agency.

Clinical studies

IVI supported clinical studies for COVID-19 vaccine by analyzing binding and neutralizing antibody from the participants.

Clinical development

Conducting a Phase I/II clinical trial of INOVIO’s COVID-19 DNA vaccine (INO-4800) at two sites in South Korea in collaboration with INOVIO and the Korea National Institute of Health

  •  After the first trial participant received the vaccine on July 13, 2020, Part A enrollment was completed with 20 people on September 8, 2020. Follow-up visits for immunogenicity and safety assessment are ongoing and first interim analysis to compare safety profiles and immunogenicity assessment between the two dose groups have been conducted. Read more

 

  • Part B of the clinical trial (Phase IIa) will expand to four clinical trial sites, and the investigator meeting and site initiation visits have been planned.

 

This study is supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

 

Conducting a Phase 3 clinical trial of SK bioscience’s recombinant protein vaccine candidate (GBP510) in Europe and Southeast Asia

  • Based on the promising interim data from Phase I/II clinical trials, SK bioscience has formed the COVID vaccine Clinical and Operational Alliance (COCOA) and is working with IVI on global Phase 3 trials of the vaccine. The aim of this consortium is to make the GBP510 vaccine available worldwide with WHO prequalification (PQ) / WHO Emergency Use Listing (EUL). IVI and SK bioscience will jointly conduct the clinical trials, while SK proceeds with preparations to achieve WHO PQ and emergency use authorization (EUA) in individual countries. Read more

 

  • SK bioscience has also received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its Phase III investigational new drug (IND) application. This is the first Phase III IND approval by the MFDS for a COVID-19 vaccine developed domestically.

 

This study is supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

 

Conducting a Phase 3 clinical trial of Sanofi and GSK’s adjuvanted recombinant-protein COVID-19 vaccine candidate (VAT00008) in Nepal

  • A parallel-group, Phase 3 multi-stage, modified double-blind multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 adjuvanted with AS03 recombinant protein vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older. Read more

 

This study is supported by Sanofi Pasteur.

Epidemiology and Capacity Building

Conducting epidemiological studies of COVID-19 in Madagascar and Burkina Faso to determine disease burden and support both countries in reporting cases to the global COVID-19 data repository

  • While COVID-19 affects virtually every region of the world, the current understanding of the disease is primarily based on surveillance and epidemiologic investigations from China, Europe, and North and South America. While a lower number of cases are reported from many low- and middle-income countries, improved studies on transmission dynamics across contexts are highly important.

 

  • IVI’s COVIA project will support local institutions in Madagascar and Burkina Faso to detect COVID-19 by putting into place surveillance measures across health care centers. Additional efforts include tracing and testing household contacts of confirmed cases to improve household transmission data. Read more

 

This study is supported by the Swedish International Development Cooperation Agency.

 

Supporting clinical trial site preparedness in four African and Asian countries for potential COVID-19 Phase III efficacy vaccine trials

  • The Gates Foundation has awarded a preparatory grant for four sites and IVI has identified sites in the Philippines, Nepal, Ghana, and Mozambique for potential future late-stage vaccine clinical trials. Read more

 

This work is supported by the Bill & Melinda Gates Foundation.

 

Investigating the impact of COVID-19 in households

  • The Household Transmission Study is uniquely positioned alongside the Clover Biopharmaceuticals COVID-19 vaccine trial and will compare SARS-CoV-2 transmission rates in vaccine recipient households with those in control vaccine recipient households in Mozambique.

 

This study is supported by Clover Biopharmaceuticals.

 

Expanding access to COVID-19 vaccines in Africa

  • The Expanding Access and Delivery of COVID-19 vaccines in Africa (ECOVA) consortium led by IVI will carry out clinical trials of Sinopharm’s BBIBP-CorV vaccine in Mozambique which will support the expanded use of the vaccine on the African continent

 

  • The ECOVA research program aims to generate crucial data to inform the use of the vaccine in Africa, and potentially expand use of the vaccine to HIV-infected individuals. All results generated by ECOVA will be made available open source to inform policy makers and regulatory authorities’ recommendations on the use of BBIBP-CorV in national immunization programs. Read more

 

This study is supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

Ask A Vaccine Expert: COVID-19

 

A video series featuring IVI scientists answering common questions about COVID-19 vaccines and vaccinations.

A global pandemic demands responses without borders.

 

All of our work is made possible by core and project funding from the governments of South Korea, Sweden, India, and Finland; foundations; global health partners; and generous individuals. In unstable times, we’re grateful for these partnerships and proud to do our part in responding to the global health crisis we face today. Join us.

Page last updated in September 2021

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