Research Center

Research Center

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The Center for Attention and Diagnosis of Infectious Diseases (CDI) has the Certification of Good Clinical Practices issued by INVIMA for the development of Research protocols with medicines in humans and certification by Icontec in ISO 9001 Quality Standard in compliance with ethical and scientific quality standards as required by national and international regulations. CDI is a member of the Colombian Association of Research Centers (ACIC) and has a research group recognized by Minciencias with classification A (COL0033186). The research group in recent years has consolidated the training of highly qualified human talent and has accumulated experience for the development of various types of studies such as clinical trials and observational studies. Likewise, the group has been characterized by the creation of collaborative networks with other groups from the public, private and academic sectors that share an interest in research in infectious diseases that generate an impact on relevant health problems in the region.

LINES OF INVESTIGATION

1. Vaccines.

Objective: Propose initiatives and develop clinical research studies that allow the evaluation of vaccines for the prevention of infectious diseases.

Achievements: Since 2010 CDI has been a pioneer in the evaluation of phase II and III clinical trials of dengue vaccine in children and adolescents. CDI has accumulated expertise in conducting Phase II and III clinical trials, specifically in evaluating the efficacy and effectiveness of vaccines for the prevention of infectious diseases. The following clinical trials have been conducted at CDI.

• Efficacy and safety of a new quadrivalent dengue vaccine in healthy children and adolescents from 9 to 16 years of age in Latin America. ClinicalTrials.gov Identifier: NCT01374516. Sponsor: Sanofi Pasteur. June 14, 2011-July 23, 2018.
• Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule. ClinicalTrials.gov Identifier: NCT02623725. Sponsor: Sanofi Pasteur. September 2016- February 2019.
• Efficacy, immunogenicity, and safety study of the Clostridium difficile toxoid vaccine in subjects at risk of developing C. difficile infection. Sponsor: Sanofi Pasteur. ClinicalTrials.gov Identifier: NCT01887912. September 19, 2013 – June 05, 2018.
• Randomized Phase 2/2B Trial to Evaluate the Safety, Immunogenicity, and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents ClinicalTrials.gov Identifier: NCT03110770. March 14, 2018 – Currently.

2. Vector-borne diseases.

Objective: Obtain information on the transmission dynamics, risk factors and disease burden associated with vector-borne infections, emphasizing endemic pathologies such as dengue and other emerging ones, which circulate in the eastern region of Colombia or have the potential to appear in tropical regions of the country.

Achievements: In the last decade, CDI researchers have carried out research studies aimed at estimating the burden of diseases transmitted by the Aedes mosquito (ETAedes) that are concentrated in urban areas [dengue, chikungunya and Zika] in order to improve their diagnosis. and prognosis, as well as its prevention under the guidelines of the Global Strategy for the Prevention of Dengue 2012-2020 of the WHO. Therefore, studies have been developed in endemic areas such as virological surveillance to predict outbreaks and strengthen surveillance in the emergence and reemergence of arboviral diseases, evaluation of the impact of the implementation of new rapid diagnostic tests for arboviral diseases in clinical settings, estimation of the burden of infections, estimation of seroprevalence and transmission dynamics of arbovirus infections, and identification of prognostic factors for ATS.

3. HIV and comorbidities.

Objective: Contribute to the generation of knowledge about the characteristics of the infection and the population affected by HIV in Colombia from a clinical perspective. This information allows us to respond to knowledge gaps to generate recommendations for the Colombian health system, in terms of prevention of transmission, treatment of the infection and its complications.

Achievements: The CDI research group has participated in a collaborative study to describe the prevalence of the HLA5701 haplotype in the Colombian population. This information has facilitated the construction of recommendations for the prescription of first-line drugs in HIV care programs. It has also fostered the acquisition of skills for the care of patients with HIV, by facilitating the tools for the preparation and execution of research theses by medical professionals in training for a master's degree in HIV.

4. Biohazard

Objective: Generate information on the behavior and characteristics of occupational and non-occupational biological risk in relation to the transmission of infectious diseases in order to identify opportunities for intervention to reduce risk and optimize the use of tools for their adequate care.

Achievements: In the Biological Risk research line, he has contributed to the construction of the Colombian guide for the prevention of HIV transmission in the context of biological risk.

RESEARCH LABORATORY.

The CDI research laboratory in recent years has strengthened its participation in research, this being in the area of ​​clinical trials and observational studies.

The structure of the laboratory rests on human talent, which is made up of professionals in bacteriology/microbiology and technicians with experience in the areas of immunology, immunohematology, chemistry, hematology, molecular biology and virology. In addition to this experience, the human resource has standardized operating procedures in the handling of biological samples (collection, reception and verification of the identification system, separation-storage and maintenance of the cold chain) based on Good Laboratory and Clinical Practices and in international standards such as the IATA/ICAO international air transport regulations, which are periodically renewed.

Regarding the physical infrastructure, the research laboratory is supported by the healthcare laboratory platforms whose areas are: sample collection, biological sample management, hematology, clinical chemistry, flow cytometry, immunology, and hormones. The molecular biology area was recently strengthened and modernized, which is intended for the development and validation, in a biosafety environment, of In-House and commercial procedures for the detection of agents that cause infectious diseases such as arboviral diseases, HIV and SARS-CoV-2.

In addition to this workflow, the research laboratory has a biorepository for biological samples in infectious diseases, made up of cold equipment that guarantees proper preservation of the samples, as well as a continuous monitoring system with remote access.

The research laboratory has established quality processes, specifically, internal and external validation processes with centers at a local, national and international level. This quality process was recently reinforced with the recognition as a partner of the EVAg project (acronym in English for the European Virus Archive Goal). Which is a non-profit organization dedicated to the characterization of biological material in the area of ​​virology worldwide. This participation will make it possible to maintain standardized and homogeneous laboratory procedures worldwide and to respond in real time to the emergency and re-emergence of infectious diseases with the implementation of diagnostic tools that allow their correct detection and characterization.