Francisco Hernández-BernalCenter for Genetic Engineering and Biotechnology | CIGB · Direction of Clinical Research
Francisco Hernández-Bernal
MD, PhD, MSc.
About
118
Publications
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Introduction
Additional affiliations
March 2003 - December 2006
National Coordinating Center for Clinical Trials
Position
- Researcher
October 1996 - July 1999
September 1990 - March 2003
Publications
Publications (118)
Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion.
Objective: To evaluate the efficacy and safety of H...
Introduction: Parapneumonic pleural effusion, empyema, pneumothorax and bronchopleural fistula are complications of pneumonia. It is recommende to use intrapleural fibrinolytics for treating empyema in the absence of bronchopleural fistula, due to the risk of tension pneumothorax.
Objective: To exhibit the clinical and radiological evolution of a s...
Objective
This study tested the hypothesis that a neuroprotective combined therapy based on epidermal growth factor (EGF) and growth hormone-releasing hexapeptide (GHRP6) could be safe for acute ischemic stroke patients, admitting up to 30% of serious adverse events (SAE) with proven causality.
Methods
A multi-centric, randomized, open-label, cont...
The convergence of life sciences with neurosciences, nanotechnology, data management, and engineering has caused a technological diversification of the biotechnology, pharmaceutical, and medical technology industries, including the phenomenon of digital transformation, which has given rise to the so-called Fourth Industrial Revolution (Industry 4.0...
El CIGB le ha apostado al empleo de los péptidos sintéticos como agentes
terapéuticos para el tratamiento de enfermedades como el cáncer, desórdenes autoinmunes y trastornos cardiovasculares, entre otras. Varios candidatos
terapéuticos peptídicos se encuentran en la etapa de solicitud de autorización de estudios clínicos o han rebasado satisfactori...
Background:
COVID-19 in paediatric ages could result in hospitalizations and death. In addition, excluding children from vaccination could turn them into reservoirs of the SARS-COV-2. Safe and effective COVID-19 vaccines are urgently needed for large-scale paediatric vaccination. ISMAELILLO study aimed to evaluate safety and immunogenicity of two...
Background: The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine.
Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three pro...
The present invention is related to the use of the growth hormone releasing peptide-6 (GHRP-6) for the manufacture of a late cardioprotective and cardiac restoration medicament. Said late cardioprotective and cardiac restoration medicament comprises GHRP-6 and a pharmaceutically acceptable excipient or vehicle. It also provides a method for the tre...
Intro: With the first case of COVID-19 in Cuba on March 11,
2020, the Center for Genetic Engineering and Biotechnology in Havana began an extensive vaccine program. Two vaccines based on RBD recombinant protein were developed, one for systemic administration “Abdala” and one mucosal vaccine “Mambisa”. Abdala received the EUA in July 2021 and "Mambi...
Introducción:
La inflamación de la pleura desencadenada por bacterias y mediada por citocinas, aumenta la permeabilidad vascular y produce vasodilatación, lo cual genera desequilibrio entre la producción de líquido pleural y su capacidad de reabsorción por eficientes mecanismos fisiológicos. La condición anterior conduce al desarrollo de derrame pl...
Introducción:
El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural.
Objetivo:
Eva...
[This corrects the article DOI: 10.1016/j.lana.2022.100366.].
Background
COVID-19 vaccines have proven safe and efficacious in reducing severe illness and death. Cuban protein subunit vaccine Abdala has shown safety, tolerability and efficacy (92·3% [95% CI: 85·7‒95·8]) against SARS-CoV-2 in clinical trials. This study aimed to estimate Abdala's real-world vaccine effectiveness (VE).
Methods
This retrospecti...
Background: The pandemic of COVID-19 raised the urgent need of safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine.
Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provi...
Background
Multiple vaccine candidates against COVID-19 are currently being evaluated. We evaluate the safety and immunogenicity protein of a novel SARS-CoV-2 virus receptor-binding domain (RBD) vaccine.
Methods
A phase 1-2, randomised, double-blind, placebo-controlled trial was carried out in “Saturnino Lora” Hospital, Santiago de Cuba, Cuba. Sub...
Objetivos:
Esta investigación tiene como objetivo estudiar los efectores inmunológicos que se inducen en los pacientes inmunizados con el CIGB-247, que incluyen elementos humorales y celulares. Este estudio pretende detectar las diferentes clases y subclases de inmunoglobulinas, evaluar su especificidad por epítopes relevantes en el VEGF y demostra...
Objetivos. Esta investigación tiene como objetivo estudiar los efectores inmunológicos que
se inducen en los pacientes inmunizados con el CIGB-247, que incluyen elementos humorales
y celulares. Este estudio pretende detectar las diferentes clases y subclases de inmunoglobulinas,
evaluar su especificidad por epítopes relevantes en el VEGF y demostra...
The primary aim of this work is to study the immunological effectors induced in CIGB-247-vaccinated patients. These effectors include humoral and cellular components of the immune system. Also, the goal of the present investigation is to detect different immunoglobulin classes and subclasses and its specificity for VEGF relevant epitopes, and demon...
Este texto tiene el propósito de brindar una herramienta docente, mediante el compendio de temas que abordan algunos conocimientos básicos y actualizados de higiene y epidemiología, para la formación académica del residente de esa especialidad. En sus 32 capítulos no lo abarca todo, pero sí facilita la información sobre las generalidades y los comp...
Aim: To evaluate the safety and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine (Abdala), administered intramuscularly in different strengths and vaccination schedules.
Method: A phase 1-2, randomized, double-blind, placebo-controlled trial was done. Subjects were randomly distributed in 3 groups: placebo, 25 and 50 μg RBD. The pro...
The invention discloses a pharmaceutical combination comprising epidermal growth factor (EGF) and the hexapeptide secretagogue GHRP6, useful for the restoration of brain damage, by stimulating mechanisms of differentiation and neuronal specialization in undifferentiated cells residing in the central nervous system or in neuronal cells. The inventio...
Introducción:
El derrame pleural paraneumónico es la enfermedad pleural más frecuente de la infancia, el 40-60 % de los casos se presenta como complicación de neumonía adquirida en la comunidad. Ante la aparición de líquido pleural viscoso, con fibrina o tabiques, la fibrinólisis intrapleural aporta beneficios en la resolución de esta grave afecció...
Introducción:
El derrame pleural paraneumónico como complicación de neumonías adquiridas en la comunidad en la población pediátrica constituye un problema de salud mundial y en Cuba. El empleo de fibrinolíticos intrapleurales es una acertada opción terapéutica.
Objetivo:
Evaluar la eficacia y seguridad de la utilización de la estreptoquinasa recom...
Objectives: IFN-alpha2b and IFN-gamma combination has demonstrated favorable pharmacodynamics for genes underlying antiviral activity which might be involved in the defense of the organism from a SARS-CoV-2 infection. Considering this we conducted a randomized controlled clinical trial for efficacy and safety evaluation of subcutaneous IFN-alpha2b...
Background: As the outbreak of COVID-19 has accelerated, an urgent need for finding strategies to combat the virus is growing. Results from in vitro studies suggest that a combination of IFN type I and Type II may be effective against SARS-CoV. The aim of this study is to investigate the efficacy of treatment with a recombinant IFN alpha 2b and gam...
Background: As the outbreak of COVID-19 has accelerated, an urgent need for finding strategies to combat the virus is growing. Results from in vitro studies suggest that a combination of IFN type I and Type II may be effective against SARS-CoV. The aim of this study is to investigate the efficacy of treatment with a recombinant IFN alpha 2b and gam...
Background:
CIGB-247 is a cancer therapeutic vaccine that uses as antigen a variant of human vascular endothelial growth factor (VEGF) mixed with the bacterially-derived adjuvant VSSP. CIGB-247 has been already evaluated in two phase I clinical trials (CENTAURO and CENTAURO-2), showing to be safe and immunogenic in advanced cancer patients selecte...
Background: CIGB-247 is a cancer therapeutic vaccine that uses as antigen a variant of human vascular endothelial growth factor (VEGF) mixed with the bacterially-derived adjuvant VSSP. CIGB-247 has been already evaluated in two phase I clinical trials (CENTAURO and CENTAURO-2), showing to be safe and immunogenic in advanced cancer patients selected...
Background: CIGB-247 is a cancer therapeutic vaccine that uses as antigen a variant of human vascular endothelial growth factor (VEGF) mixed with the bacterially-derived adjuvant VSSP. CIGB-247 has been already evaluated in two phase I clinical trials (CENTAURO and CENTAURO-2), showing to be safe and immunogenic in advanced cancer patients selected...
Background: CIGB-247 is a cancer therapeutic vaccine that uses as antigen a variant of human vascular endothelial growth factor (VEGF) mixed with the bacterially-derived adjuvant VSSP. CIGB-247 has been already evaluated in two phase I clinical trials (CENTAURO and CENTAURO-2), showing to be safe and immunogenic in advanced cancer patients selected...
Polypeptides comprising functional mutants of an isoform of the human vascular endothelial growth factor A (VEGF-A), folded in a non-natural re-arrangement of disulfide bonds, where the second and fourth cysteine of the polypeptide chain of the mutants are only found forming intramolecular bonds, while the seventh and eight cysteine of the mutants...
Background: CIGB-247 is a cancer therapeutic vaccine that uses as antigen a variant of human vascular endothelial growth factor (VEGF) mixed with the bacterial-derived adjuvant VSSP. This VEGF vaccine has been evaluated in phase I clinical trials CENTAURO and CENTAURO-2, showing to be safe and immunogenic in advanced cancer patients selected under...
Objectives:
Vascular endothelial growth factor (VEGF) is involved in physiological angiogenesis, but also is considered one of the key factors that promotes tumor angiogenesis. CIGB-247 is a VEGF-based vaccine that has been evaluated in phase I clinical trial patients with advanced solid tumors. This specific active immunotherapy is able to reduce...
Abstract
Objectives: Vascular endothelial growth factor (VEGF) is involved in physiological angiogenesis, but also is considered one of the key factors that promotes tumor angiogenesis. CIGB-247 is a VEGF-based vaccine that has been evaluated in phase I clinical trial patients with advanced solid tumors. This specific active immunotherapy is able t...
Two phase I clinical trials were conducted to evaluate, among other parameters, the humoral response elicited by a vascular endothelial growth factor (VEGF)-based therapeutic vaccine in cancer patients with advanced solid tumors. VEGF reduction was studied using an indirect methodology named as “Platelet VEGF”. This methodology is based on the esti...
Introducción: El cáncer constituye un problema de salud mundial. Objetivo: Evaluar en humanos un candidato vacunal de inmunoterapia activa específica con factor de crecimiento del endotelio vascular (VEGF) como diana. Materiales y Métodos: Se realizó un ensayo clínico fase I, de escalado de dosis, que evaluó seguridad, tolerancia e inmunogenicidad...
HEBERSaVax is a cancer therapeutic vaccine candidate based on the combination of a recombinant antigen representative of human vascular endothelial growth factor (VEGF), and clinically tested adjuvants. The vaccine has been shown to inhibit tumor growth and metastases in mice, and to induce VEGF-blocking antibodies and specific T-cell responses in...
Background
CIGB-247, a VSSP-adjuvanted VEGF-based vaccine, was evaluated in a phase I clinical trial in patients with advanced solid tumors (CENTAURO). Vaccination with the maximum dose of antigen showed an excellent safety profile, exhibited the highest immunogenicity and was the only one showing a reduction on platelet VEGF bioavailability. Howev...
CIGB-247 is a cancer therapeutic vaccine, based on recombinant modified human vascular endothelial
growth factor (VEGF) as antigen, in combination with the adjuvant VSSP, a bacterially-derived adjuvant.
The vaccine have demonstrated efficacy in several murine malignancy models. These studies supported
the rationale for a phase I clinical trial wher...
BACKGROUND
Growth hormone-releasing peptides (GHRPs) constitute a group of small synthetic peptides that stimulate the growth hormone secretion and the downstream axis activity. Mounting evidences since the early 1980s delineated unexpected pharmacological cardioprotective and cytoprotective properties for the GHRPs. However, despite intense basic...
CIGB-247 is cancer vaccine candidate that uses a recombinant variant of the human Vascular Endothelium Growth Factor (VEGF) isoform 121 as antigen, in combination with VSSP, a bacterially-derived adjuvant. Four years ago, CIGB-247 was studied in a phase I clinical trial (code name CENTAURO), where the vaccine was administered to thirty patients wit...
ABSTRACTS CIGB-247, a VEGF-based vaccine, was studied in a clinical trial. This advance demands the refinement of the methodologies for assessment of vaccine immune responses. This study aimed to improve the performance of ELISAs for detecting IgG antibodies against human VEGF and the blocking activity of the serum to inhibit the VEGF/VEGFR2 intera...
AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease.
METHODS: A multicenter (11 sites), randomized (1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written, informed consent. After inclusion, p...
Antecedentes. Entre las nuevas estrategias de desarrollo de medicamentos anti-angiogénicos para el cáncer y otras enfermedades, la inmunoterapia activa específica es una línea de trabajo con intensa investigación, una de cuyas posibles ventajas está en el bajo perfil de toxicidad de estos tipos de tratamiento. Solo unos pocos candidatos vacunales h...
Introduction: Hemorrhoidal disease is a global health problem and Cuba is not exempt from it, but the literature does not collect epidemiological information on this issue in the Cuban population. The aim of this work is to characterize the acute hemorrhoidal disease in selected Cuban hospitals, with emphasis on the risk factors that favor the appe...
CIGB-247 is a novel cancer therapeutic vaccine that uses a human VEGF variant molecule as antigen, in combination with a bacterial adjuvant. In mice, CIGB-247 has anti-tumor and anti-metastatic effects. The vaccine induces anti-VEGF blocking antibodies and a cellular response targeting tumor cells producing VEGF, and has proven to be safe in mice,...
Aim: To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease.
Methods: A multicenter (14 sites), randomized (1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed...
Introduction: hemorrhoidal disease is a global health problem. In Cuba, however, epidemiological data about the population is not available in the literature on the subject. That is the reason why the present paper is aimed at characterizing acute hemorrhoidal disease in selected Cuban hospitals, with particular emphasis on the risk factors leading...
Las hemorroides son dilataciones de los plexos venosos de la mucosa del recto o
del ano y constituye un problema de salud mundial de alta incidencia. Para su
tratamiento existen formulaciones de aplicación local que centran su principal
acción en la disminución de la inflamación y el dolor, pero ninguna elimina los
trombos y microtrombos presentes...
Aim: To explore the effect and safety of recombinant streptokinase (rSK) at two dose levels in sodium salicylate (SS) – containing suppositories, compared to their excipients, for the treatment of acute haemorrhoidal disease.
Method: A multicentre, randomised, double-blind, placebo-controlled trial was done. Patients with acute symptoms of haemorr...
After several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice.
A prospective, post-mar...
GHRP-6 is a growth hormone secretagogue that also enhances tissue viability in different organs. In the present work, we studied the pharmacokinetics of this short therapeutic hexapeptide (His-(D-Trp)-Ala-Trp-(D-Phe)-Lys-NH(2,) MW = 872.44 Da) in nine male healthy volunteers after a single intravenous bolus administration of 100, 200 and 400 μg/kg...
GHRP-6 is a growth hormone secretagogue that also enhances tissue viability in different organs. In the present work, we studied the pharmacokinetics of this short therapeutic hexapeptide (His-(D-Trp)-Ala-Trp-(D-Phe)-Lys-NH(2,) MW = 872.44 Da) in nine male healthy volunteers after a single intravenous bolus administration of 100, 200 and 400 μg/kg...
RESUMEN Se estudió un paciente masculino, negro, de 17 años de edad, caribeño, aparentemente sano hasta el año 2007 cuando aparece un tumor témporo-parieto-frontal izquierdo de crecimiento rápido, que compromete la cara. Al examen físico se constató, además, piel y mucosas pálidas con desnutrición severa. El diagnóstico histopatológico fue de melan...
The case of a black Caribbean patient aged 17 apparently healthy until 2007 when to appear a left temporal-parietal-frontal tumor of fast growth involving the face. At physical examination authors also confirmed a pale skin and mucosae with a severe malnutrition. The histopathological diagnosis was a malignant melanoma of epithelioid cells.
A post-marketing, double blind, randomized, controlled clinical trial to assess the immunogenicity and safety profiles of four commercially available recombinant hepatitis B vaccines was performed. The vaccines included in this study were Heberbiovac-HB(R) (Heber Biotec S. A., Havana, Cuba), Euvax-B(R) (LG Chemical Ltd., Seoul, Korea), Hepavax-Gene...
A proof-of-concept, pilot clinical trial was carried out in 2 hospitals, to evaluate the safety of recombinant streptokinase (rSK) administered by the rectal route in patients with acute hemorrhoidal disease (AHD). Suppositories containing 200 000 IU rSK were given every 6 hours, up to 4 applications. The patients, after discharge, were seen daily...
A proof-of-concept, pilot clinical trial was carried out in 2 hospitals, to evaluate the safety of recombinant streptokinase (rSK) administered by the rectal route in patients with acute hemorrhoidal disease (AHD). Suppositories containing 200 000 IU rSK were given every 6 hours, up to 4 applications. The patients , after discharge, were seen daily...
A proof-of-concept, pilot clinical trial was carried out in 2 hospitals, to evaluate the safety of recombinant streptokinase (rSK) administered by the rectal route in patients with acute hemorrhoidal disease (AHD). Suppositories containing 200 000 IU rSK were given every 6 hours, up to 4 applications. The patients , after discharge, were seen daily...
Radiogenic proctitis is a frequent complication of therapeutic radiation at the pelvic region. The aim of this study was to determine the efficacy of the epidermal growth factor (EGF) in treating patients with proctitis as a complication of radiotherapy of gynecological tumors. A phase II, placebo-controlled, randomized, double blind clinical trial...
A descriptive and cross-sectional study was made to identify risk factors in adolescents from a health area of the Cuban capital during 2004. The universe was composed of students attending two secondary schools located in the area, and of integral general professors teaching these students. 364 adolescents, among students and professors, were surv...
A descriptive and cross-sectional study was made to identify risk factors in adolescents from a health area of the Cuban capital during 2004. The universe was composed of students attending two secondary schools located in the area, and of integral general professors teaching these students. 364 adolescents, among students and professors, were surv...
OBJECTIVE: to make a critical analysis of a control of HIV/AIDS focus, selected at random in a municipality of the Cuban capital in 2005. DEVELOPMENT: the generated and available documentation of the case was reviewed, and different authorities of the health area linked to the fulfilment of the HIV/AIDS Control and Prevention Program were interview...
OBJECTIVE: to make a critical analysis of a control of HIV/AIDS focus, selected at random in a municipality of the Cuban capital in 2005. DEVELOPMENT: the generated and available documentation of the case was reviewed, and different authorities of the health area linked to the fulfilment of the HIV/AIDS Control and Prevention Program were interview...
OBJECTIVE: to make a critical analysis of a focus control carried out in a patient at pediatric age with pulmonary tuberculosis that was selected at random in a municipality of Havana City province, in 2005. DEVELOPMENT: the generated and available documentation was reviewed, and different authorities of the health area linked to the Tuberculosis C...
OBJECTIVE: to make a critical analysis of a focus control carried out in a patient at pediatric age with pulmonary tuberculosis that was selected at random in a municipality of Havana City province, in 2005. DEVELOPMENT: the generated and available documentation was reviewed, and different authorities of the health area linked to the Tuberculosis C...
Manufactures of biotechnological/biological products (including vaccines) frequently make changes to manufacturing processes of products both during development and after approval. In our case, a non-inferiority bridging study was carried out to demonstrate that changes in the production plant facilities of Cuban recombinant hepatitis B vaccine, He...
To evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of two recombinant G-CSF formulations in healthy male volunteers, a standard 2-way randomized crossover double-blind study, with a 3 week washout period, was conducted. A single 300 microg G-CSF dose was administered subcutaneously. Hebervital (Heber Biotec, H...
Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice.
A national, prospective and spontaneous reporting-based pharmac...
Objective:
Interferon (IFN) alpha-2b is a protein with antiviral, antiproliferative and immunoregulatory properties that is approved for several clinical indications. A new liquid, albumin-free, IFNalpha-2b formulation has recently been developed. This study aimed to evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety prope...
In the large-scale trial, Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-3 (GISSI-3), patients receiving the combination of lisinopril and glyceryl trinitrate benefited most from experimental therapy. Therefore, a multicenter, randomized, double-blind study, Delapril Remodeling After Acute Myocardial Infarction (DRAMI), w...
Background: Although placing patients with acute respiratory failure in a prone (face down) position improves their oxygenation 60 to 70 percent of the time, the effect on survival is not known.
Methods: In a multicenter, randomized trial, we compared conventional treatment (in the supine position) of patients with acute lung injury or the acute r...
Our aim was to study the efficacy of oral human recombinant epidermal growth factor (EGF) in the treatment of duodenal ulcers, on the basis of its repairing actions in the gastrointestinal tract.
A placebo-controlled, multicenter, randomized, and double-blind study was conducted. Treatment groups were A) placebo solution, B) 10 microg/ml of human r...
