About us

It is a synergistic organizational structure that articulates functionally and contractually, intra and inter-business / institutional relations, in order to respond jointly and flexibly, under the direction of the Finlay Vaccine Institute, to the demand for clinical research, epidemiological studies and pharmacovigilance, as well as the evaluation of effectiveness and social and health impact related to its products and technologies in favor of a scientifically supported technical-managerial decision making.

Mission

The Directorate of Clinical Research and Impact Evaluation of the Finlay Institute is responsible for designing and implementing clinical research, surveillance studies, evidence analysis and studies evaluating social and health impact of its products and technologies to contribute effectively, efficiently and with high quality standards to scientifically supported decision making.

Vision

The Directorate of Clinical Research and Impact Evaluation of the Finlay Institute will be recognized as a specialized leader in clinical research, epidemiological and evaluation studies and the synthesis and analysis of evidence related to its products and technologies.

Vaccine Candidates

SOBERANA 01: Vaccine candidate against SARS-CoV-2 FINLAY-FR-1

Vaccine Candidates have the following Studies:
Phase I / II Clinical Trial, Safety, reactogenicity and immunogenicity
Soporte

2020

In progress

Type of study

Community Intervention Trial

Objective

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of the FINLAY-FR-1 vaccine candidate in a two-dose schedule (0 - 28).

Population

Apparently healthy adults of both sexes, between 19 and 80 years of age, of Cuban nationality, and who grant their consent to participate will be included.

Sample (n)

676

Site

CENATOX, National Toxicology Center / 19 de Abril Polyclinic (Plaza de la Revolución Municipality) / Clinic 1 La Lisa

Researchers / Collaborators

Dra. Sonia Pérez Rodríguez

CENATOX,  La Habana.
eclinicos@infomed.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Dra. Meiby de la C. Rodríguez

Finlay, La Habana.
mcrodriguez@finlay.edu.cu

Pneumococcal (PCV7-TT)

Vaccine Candidates have the following Studies:
Evaluation of effectiveness and impact
Soporte

2016

In preparation

Type of study

Community Intervention Trial

Objective

Evolution of the direct effects in vaccinated and indirect in cohabiting and the population impact on colonization and diseases associated with pneumococcus.

Population

Children 1-5 years old and living together

Sample (n)

12300

Site

Health Areas (APS) of Cienfuegos province

Researchers / Collaborators

Dunia Chávez

HPPGC,  Cienfuegos.
metmed5807@ucm.cfg.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Dr. Nivaldo Linares Pérez

CQB-Finlay, La Habana.
nlinares@finlay.edu.cu
Pharmacovigilance
Soporte

2017-2020

In preparation

Type of study

Pharmacovigilance

Objective

ESAVI surveillance

Population

Pediatric age with emphasis on children under 5 years old

Sample (n)

All cases hospitalized and treated in the PHC

Site

HPGC (Cienfuegos), HPIS y HPIN (Santiago de Cuba), HJMM, HPWS, HPCH (La Habana).

Researchers / Collaborators

Dr. Ivan Cuevas

CQB-Finlay, La Habana.
cuevas@finlay.edu.cu
Pneumococcal diseases
Soporte

2014-2018

In progress

Type of study

Sentinel Surveillance Study

Objective

Clinical characterization of cases, circulation of serotypes and hospital burden of disease

Population

Pediatric age with emphasis on children under 5 years old

Sample (n)

All hospitalized cases

Site

HPGC (Cienfuegos), HPIS y HPIN (Santiago de Cuba), HJMM, HPWS, HPCH (La Habana)

Researchers / Collaborators

Gilda Toraño

IPK, La Habana.
gilda@ipk.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Nivaldo Linares Pérez

CQB-Finlay, La Habana
nlinares@finlay.edu.cu
Colonization
Soporte

2016

Not started

Type of study

Descriptive cross-sectional observational

Objective

Prevalence of global colonization and serotypes in children 1-5 years old and living in Santiago de Cuba

Population

1-5 year old children and co-survivors belonging to irrigation groups

Sample (n)

570 households - children 1-5 years

Site

6 Health Areas (PHA) of the municipality of Santiago de Cuba

Researchers / Collaborators

José R Guillen

CPHEM, Santiago de Cuba.
jrguillen@cphem.scu.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Dr. Nivaldo Linares Pérez

CQB-Finlay, La Habana.
nlinares@finlay.edu.cu
Soporte

2015-2016

In progress

Type of study

Observational analytical monitoring

Objective

Frequency of illness, hospitalization and changes in colonization one year after vaccination.

Population

1-5 year old children vaccinated

Sample (n)

570 children 1-5 years vaccinated

Site

8 Health Areas (PHA) of the Cienfuegos municipality

Researchers / Collaborators

Dunia Chávez

HPPGC,  Cienfuegos.
metmed5807@ucm.cfg.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Dr. Nivaldo Linares Pérez

CQB-Finlay, La Habana.
nlinares@finlay.edu.cu
Soporte

2014

Concluded

Type of study

Descriptive cross-sectional observational

Objective

Prevalence of global colonization and serotypes

Population

Children, 3-18 months

Sample (n)

978

Site

Health Areas (PHA) Cienfuegos

Researchers / Collaborators

Maria Felicia Casanova

HPPGC,  Cienfuegos.
neurofisiologia@hosped.cfg.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Lic. Beatriz Paredes

CQB, La Habana.
bparedes@finlay.edu.cu
Clinical evaluation
Soporte

2016

Not started

Type of study

EC Phase I-II

Objective

Safety (reactogenicity) Immunogenicity, not inferiority, comparison of schemes and booster effect

Population

2-4 months

Sample (n)

520, (120 phase I y 300 phase II)

Site

HJMM La Habana y HPPG Cienfuegos Áreas de Salud (APS) de Cienfuegos y La Habana

Researchers / Collaborators

Carlos Dotres

HJMM, La Habana.
cpablo@infomed.sld.cu

Maria Felicia Casanova

HPPGC,  Cienfuegos.
neurofisiologia@hosped.cfg.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Nivaldo Linares Pérez

CQB-Finlay, La Habana.
nlinares@finlay.edu.cu
Soporte

2014-2015

In progress

Type of study

EC Phase II-III

Objective

Immunogenicity, not inferiority

Population

Preschoolers 12-23 months and 2-5 years

Sample (n)

1135

Site

Health Areas (PHA) Cienfuegos

Researchers / Collaborators

Maria Felicia Casanova

HPPGC,  Cienfuegos.
neurofisiologia@hosped.cfg.sld.cu

Maria Eugenia Toledo

IPK, La Habana.
mariaeugenia@ipk.sld.cu

Lic. Beatriz Paredes

CQB, La Habana.
bparedes@finlay.edu.cu
Soporte

2013-2014

Concluded

Type of study

EC Phase I

Objective

Safety (reactogenicity) and immunogenicity scan

Population

Preschoolers, 4-5 years and Infants, 7-11 months

Sample (n)

45

Site

HJMM

Soporte

2012

Concluded

Type of study

EC Phase I

Objective

Safety (reactogenicity)

Population

Adults, 18-35 años

Sample (n)

20

Site

CENATOX