IVI and Colombia
Official Relations
2021 Visit by the President of Colombia
The President of the Republic of Colombia, His Excellency Iván Duque Márquez, paid an official visit to IVI headquarters in Seoul during his state visit to the Republic of Korea. The delegation from Colombia included Madame María Juliana Ruiz, First Lady, His Excellency Fernando Ruiz, Minister of Health and Social Protection of Colombia, and His Excellency Juan Carlos Caiza Rosero, Ambassador of Colombia to the Republic of Korea.
During the visit, President Duque delivered a letter of intention to IVI Director General Jerome Kim for Colombia to become an IVI member state. Subsequently, a Memorandum of Understanding was signed between the Ministry of Health and Social Protection of Colombia and IVI to explore opportunities for future collaboration and knowledge sharing in the areas of capacity building, infectious disease research, epidemiology, and vaccine research and development.
President Duque made an address at IVI, stating “IVI is an institution that saves lives. We acknowledge that in these difficult times we are facing in history, there must be more cooperation and equality in distributing vaccines around the world. Becoming a member of IVI is a must for a country like Colombia. And it is a must not only to face the challenges of COVID-19, but to be able to develop vaccines and distribute vaccines for common illness we face on a regular basis.”
Ongoing Collaboration
COCOA-H: COVID vaccine Clinical and Operational Alliance
IVI is collaborating with SK bioscience through the COCOA consortium to advance the development of SK’s COVID-19 recombinant protein nanoparticle vaccine with funding from CEPI. The funding for COCOA-H was awarded in June 2022, and IVI is responsible for leading the phase III heterologous booster clinical trial.
The study title is “A Phase III, Placebo-controlled, Randomized, Observer-blinded, Multi-national, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in Adults Aged 18 Years and Older’’.
The primary objective is to assess and compare the immune responses against the original strain before and post heterologous dose of GBP510 25µg adjuvanted with AS03 and demonstrate superiority in adults aged 18 years and older without prior of SARS-CoV-2 infection. Another primary objective is to assess the immune response against circulating variants of concern (i.e., Omicron variant) induced by a single heterologous booster dose of GBP510 25µg adjuvanted with AS03 (a subset of at least approximately 10% of participants may be randomly selected from the Test and Placebo groups in each cohort).
Participants will receive 2 doses of primary vaccination in 6 predefined cohorts at least 12 weeks before being recruited and will be followed up for 12 months after recruitment. The participants will be unblinded after 4 weeks of recruitment and the Placebo group population will be advised to receive a booster vaccine that is available in their country.
The consortium agreement was executed in June 2022, and recruitment was completed in both Nepal and Colombia in early August 2023. The 3rd Data and Safety Monitoring Board (DSMB) meeting was completed in July 2023 and no safety concern was raised. Preparation for interim analysis is ongoing and will be completed in early 2024. Study activities are ongoing in both countries without any major roadblocks
In Colombia, the COCOA-H project is conducted in collaboration with the Centro de Atencion Investigacion Mecica (CAIMED), Policlinicio Social de Norte, and ICON plc in Bogotá.
IVI’s Global Chikungunya vaccine Clinical Development Program (GCCDP) was initiated in June 2020 in partnership with Bharat Biotech in India to advance Bharat’s chikungunya vaccine candidate with the ultimate goal of achieving WHO prequalification and emergency use listing. This program involves a Phase II/III randomized, controlled vaccine clinical trial with an adaptive and seamless design to evaluate the safety and immunogenicity of a two-dose regimen of BBV87 chikungunya vaccine in healthy subjects aged 12-65 years in five countries across Asia and Latin America, including Colombia, Costa Rica, Guatemala, Panama, and Thailand. These studies are running in parallel to Bharat Biotech’s clinical trials in India as part of the global clinical development plan of BBV87 vaccine.
From November 2022 to February 2023, the team finalized data sets for Parts A and B of the study. Subsequently, the third Data and Safety Monitoring Board meeting concluded in May 2023 with no identified safety issues. The optimal dose for Part C has been selected and supported by the immunogenicity and safety data and results of the non-human primate study. Beginning 2024, recruitment for Part C will be initiated and consultations with WHO entities, NRAs, and National Immunization Technical Advisory Groups (NITAGs) will continue.
In December 2023, IVI convened the first Chikungunya Global Stakeholder Meeting in Panama in partnership with Gorgas Institute, bringing together stakeholders across government, research and development, and industry to map a comprehensive landscape of the problem of chikungunya and to advocate for the recognition, approval, and support of a global chikungunya vaccine agenda.
In Colombia, the GCCDP project is conducted in collaboration with CAIMED, CDLC, and CDI.
Previous Collaboration
Phase 3 clinical trials of SK bioscience’s licensed recombinant protein vaccine candidate (GBP510)
IVI coordinated global clinical trials of SK bioscience’s GBP50 vaccine in five countries: Korea, New Zealand, the Philippines, Thailand, Ukraine, Vietnam, and Colombia.
These trials demonstrated both superiority and non-inferiority of the vaccine compared to the comparator vaccine (AstraZeneca’s Vaxzevria®).
Based on the results, the GBP510 (brand name SKYCovione™) was licensed by the Korean Ministry of Food & Drug Safety in June 2022.
Zika
IVI partnered with Fundación Universidad del Norte and Universidad del Valle in Colombia to form ZikaPLAN (Zika Preparedness Latin American Network), a consortium which works to prevent the spread of Zika virus by developing a better understanding of the disease and building a sustainable preparedness and response capacity in Latin America.
Dengue Disease Surveillance and Economic Impact Studies
IVI established two consortiums to implement its dengue vaccine efforts: the Pediatric Dengue Vaccine Initiative (PDVI) and the subsequent Dengue Vaccine Initiative (DVI).
DVI sponsored the dengue surveillance studies of Colombia’s Dr. Jorge Osorio in the endemic area of Medellin, Colombia and provided funding for the development of a field site to study the disease and transmission factors. This work provided important information on the natural history of dengue, such as evolution of circulating viruses, clinical characterization of the disease and the economic burden of the disease. The studies in Colombia informed the development of a statistical and mathematical model for understanding the vectors of dengue transmission and the potential impact of dengue vaccine immunization.
As part of DVI’s dengue surveillance in Colombia and Thailand, IVI’s Policy and Economic Research team conducted healthcare utilization surveys, household surveys, and cost of illness surveys to estimate the economic burden of dengue patients and the household demand for dengue vaccines. The results suggested that a private market for dengue vaccines exists in Colombia, Thailand, and Vietnam and that sales may be robust if vaccine prices are low enough.
International Cooperation on Dengue Research
In 2015, DVI convened the Americas Dengue Prevention Board at the Colombian National Health Institute (Instituto Nacional de Salud de Colombia – INS) with scientists, global health experts, mathematicians, and representatives of dengue vaccine manufacturers to discuss updates in dengue vaccines and vaccine introduction. The meeting was instrumental given the new available clinical trial data, particularly the results of the first Phase III trials ever completed for a dengue vaccine candidate. These results demonstrated that a safe and effective dengue vaccine is feasible.
In 2013, DVI hosted a number of meetings between dengue vaccine developers and the national regulatory authorities (NRAs) of Brazil, Colombia, Indonesia, Malaysia, Mexico, the Philippines, and Thailand to share perspectives on vaccine licensure and the introduction of dengue vaccine into their national immunization programs. The NRAs of the attending countries agreed to explore join evaluations of vaccine candidates, the sharing of epidemiological data, and the establishment of contacts between their respective Ministries of Health.
In 2012, PDVI sponsored the meeting of the Pan American Dengue Research Network in Cartagena, Colombia and provided funding to support the participation of young scientists. Chaired by Dr. Jorge Osorio of the Universidad de Antioquia, the meeting brought together 219 scientists from 22 countries and presented progress updates on all of the dengue vaccines in clinical testing at that time and surveillance studies on dengue infection in Colombia, Nicaragua, and Peru.