Gerardo Guillen

Gerardo Guillen
Center for Genetic Engineering and Biotechnology | CIGB · Biomedical Research Direction

Dr.

About

322
Publications
43,641
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4,120
Citations
Citations since 2016
104 Research Items
1907 Citations
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Introduction
Gerardo Guillen currently works at the Area of Biomedical Research, Center for Genetic Engineering and Biotechnology. Gerardo does research in Infectious Diseases, Biotechnology and Cancer Research. Their current projects are 'Hepatitis B therapeutic vaccine, Dengue vaccine, Acellular Pertussis Vaccine, Prostate Cancer Vaccine, Cardioprotection, Wound healing.'

Publications

Publications (322)
Article
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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...
Article
Aims: HBsAg loss with anti-HBs acquisition is considered a functional cure and ideal treatment goal for patients with CHB. Our group have reported the efficacy of therapeutic vaccine with HBsAg and HBcAg (NASVAC) by intranasal and subcutaneous injection. In this study, we investigated the safety and efficacy of newly developed CVP-NASVAC, which co...
Article
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Cytokines, demyelination and neuroaxonal degeneration in the central nervous system are pivotal elements implicated in the pathogenesis of multiple sclerosis (MS) and its nonclinical model of experimental autoimmune encephalomyelitis (EAE). Phycocyanobilin (PCB), a chromophore of the biliprotein C-Phycocyanin (C-PC) from Spirulina platensis, has an...
Article
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Introduction: Subjects with asymptomatic infections are not generally admitted to health care facilities, however, they may benefit from antiviral therapy. Objective: To evaluate the contribution to treatment with combined therapy based on recombinant human interferon alpha 2b + Lopinavir/Ritonavir + Chloroquine versus Lopinavir/Ritonavir + Chloroq...
Article
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Cellular memory is a controversial concept representing the ability of cells to “write and memorize” stressful experiences via epigenetic operators. The progressive course of chronic, non-communicable diseases such as type 2 diabetes mellitus, cancer, and arteriosclerosis, is likely driven through an abnormal epigenetic reprogramming, fostering the...
Article
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Developing affordable and easily manufactured SARS-CoV-2 vaccines will be essential to achieve worldwide vaccine coverage and long-term control of the COVID-19 pandemic. Here the development is reported of a vaccine based on the SARS-CoV-2 receptor-binding domain (RBD), produced in the yeast Pichia pastoris. The RBD was modified by adding flexible...
Preprint
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Despite the rapid development of vaccines and their reported efficacy for controlling the COVID-19 waves, two key challenges remain: the scope of the immunity against upcoming variants and zoonosis events, and the induction of mucosal immunity able to clear the virus in the upper respiratory tract for halting the transmission. The present study is...
Article
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Chronic hepatitis B (CHB) is a highly complicated pathological process in which the disease is initiated by the hepatitis B virus (HBV); however, host immune responses are primarily responsible for variable extents of liver damage. If the patients with CHB remain untreated, many CHB patients will eventually develop complications like cirrhosis of t...
Article
Background: A low cost and simple real-time PCR method to quantify different transcripts in human samples is a need in most developing countries. A quantitative real-time PCR assay to evaluate the relative RNA expression stimulation of specific transcripts during the Pandemic COVID19 scenario was developed at the Center for Genetic Engineering and...
Article
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Background Because of high prevalence of Alzheimer’s disease (AD) in low- and middle-income countries (LMICs), there is an urgent need for inexpensive and minimally invasive diagnostic tests to detect biomarkers in the earliest and asymptomatic stages of the disease. Blood-based biomarkers are predicted to have the most impact for use as a screenin...
Article
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Diabetes mellitus remains as a pandemic disease, associated to progressive and irreversible complications including lower extremity ulcerations, derived from a predisposition to ischemia, neuropathy and an intrinsic wound healing failure. The molecular operators supporting wound chronicity remain elusive, but a local deficit of growth factors is in...
Article
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Introduction: The detection of SARS-CoV-2 genetic material from nasopharyngeal swab samples by RT-PCR is the most specific and sensitive way to test suspected cases. However, factors such as the sampling process, the type of hyssop used, and the anatomical area from which the sample is collected can distort the result and cause false negatives. Ob...
Article
We conducted an experimental protocol with a nasal recombinant IFNα-2b formulation (Nasalferon) in 12 healthy volunteers who received 1 MIU per nostril twice a day, three consecutive days, and studied the induction of biomarkers related to antiviral and immune responses. Nasalferon increases the antiviral biomarker OAS1 transcript levels in orophar...
Article
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Lower-extremity arterial disease is a major health problem with increasing prevalence, often leading to non-traumatic amputation, disability and mortality. The molecular mechanisms underpinning abnormal vascular wall remodeling are not fully understood. We hypothesized on the existence of a vascular tissue memory that may be transmitted through sol...
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Carcinogenesis is a vast and heterogeneous, multi-step process driven by genetic and epigenetic operators leading to superimposed "tumor organs". Based on our previous experiences of reproducing human donor's histopathological hallmarks in healthy animals exposed to pathologic tissues homogenates, we examined the consequences of administering crude...
Article
Since the beginning of the COVID-19 pandemic, the development of effective vaccines against this pathogen has been a priority for the scientific community. Several strategies have been developed including vaccines based on recombinant viral protein fragments. The receptor-binding domain (RBD) in the S1 subunit of S protein has been considered one o...
Article
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The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcut...
Article
Subunit vaccines based on the receptor-binding domain (RBD) of the spike protein of SARS-CoV-2 provide one of the most promising strategies to fight the COVID-19 pandemic. The detailed characterization of the protein primary structure by mass spectrometry (MS) is mandatory, as described in ICHQ6B guidelines. In this work, several recombinant RBD pr...
Article
Full-text available
A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA,...
Article
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Introduction: More than 180 million people have been infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and more than 4 million coronavirus disease-2019 (COVID-19) patients have died in 1.5 years of the pandemic. A novel therapeutic vaccine (NASVAC) has shown to be safe and to have immunomodulating and antiviral properties ag...
Preprint
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SARS-CoV-2, a recently emerged coronavirus, is causing high morbidity and mortality worldwide since December 2019, posing an enormous health, social and economic problem. Obtaining effective treatments that can diminish deaths and sequelae and vaccines to slow or prevent viral transmission, and reduce disease severity and/or death are of utmost imp...
Article
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With the advent of various vaccines and antimicrobial agents during the 20th century, the control and containment of infectious diseases appeared to be a matter of time. However, studies unveiled the diverse natures of microbes, their lifestyle, and pathogenetic potentials. Since the ground-breaking discovery of the hepatitis B virus (HBV) by Baruc...
Article
BACKGROUND Diabetic foot ulcers are a common diabetic complication leading to alarming fi gures of amputation, disability, and early mortality. The diabetic glucooxidative environment impairs the healing response, promoting the onset of a ‘wound chronicity phenotype’. In 50% of ulcers, these non-healing wounds act as an open door for developing inf...
Article
We herein report, by using confocal immunofluorescence, the colocalization of the SARS-CoV-2 nucleocapsid within neurons, astrocytes, oligodendrocytes and microglia in three deceased COVID-19 cases, of between 78 and 85 years of age at death. The viral nucleocapsid was detected together with its ACE2 cell entry receptor, as well as the NLRP3 inflam...
Article
Introducción: El dengue es una de las enfermedades más importantes trasmitida por mosquitos; sin embargo, solo existe una vacuna licenciada, la cual está registrada en 20 países. Sin embargo, la vacuna no podrá ser administrada en niños menores de nueve años de edad, dado el elevado riesgo de hospitalización observado en este grupo etario. Por lo t...
Preprint
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The effort to develop vaccines based on economically accessible technological platforms available by developing countries vaccine manufacturers is essential to extend the immunization to the whole world population and to achieve the desired herd immunity, necessary to end the COVID-19 pandemic. Here we report on the development of a SARS-CoV-2 rece...
Article
The coronavirus 2019 (COVID-19) pandemic has resulted in 168 million cases and about 3.5 million deaths (as of May 26, 2021) during the last 18 months. These 18 months of the COVID-19 pandemic have been characterized by phases or waves of new cases, the emergence of new variants of the deadly virus, and several new complications. After providing em...
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The EGF promotes inhibition of cell proliferation in vitro and in vivo models depending on its concentration, application schema and the type of tumor cells on which it acts. Our research hypothesis was based on the fact that the EGF varies the expression of genes involved in a negative regulation of tumor cell lines proliferation carrying high lev...
Article
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Background: Acute stroke treatment is a time-critical process in which every minute counts. Laboratory biomarkers are needed to aid clinical decisions in the diagnosis. Although imaging is critical for this process, these biomarkers may provide additional information to distinguish actual stroke from its mimics and monitor patient condition and the...
Article
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Introduction: The SARS-CoV-2 virus is a positive-strand RNA virus. The virus can also be detected in many different specimens as throat swabs, nasal swabs, sputum, saliva, blood, etc. Objective: The aim of this paper is to compare the reliability of different types of specimen collection, saliva and swabs samples for the detection of SARS-CoV-2....
Preprint
Full-text available
Subunit vaccines based on the receptor-binding domain (RBD) of the spike protein of SARS-CoV-2, are among the most promising strategies to fight the COVID-19 pandemic. The detailed characterization of the protein primary structure by mass spectrometry (MS) is mandatory, as described in ICHQ6B guidelines. In this work, several recombinant RBD protei...
Preprint
Full-text available
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the subsequent coronavirus 2019 (COVID-19) have led to tens of millions of cases and millions of deaths around the world. Although more than a year has passed since the emergence of COVID-19, more waves of the pandemic, with new variants of the deadly virus, have been reported. It see...
Article
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Lower limb ulcers in type-2 diabetic patients are a frequent complication that tributes to amputation and reduces survival. We hypothesized that diabetic healing impairment and other histopathologic hallmarks are mediated by a T2DM-induced tissue priming/metabolic memory that can be transferred from humans to healthy recipient animals and consequen...
Article
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The pandemic distribution of SARS-CoV-2 together with its particular feature of inactivating the interferon-based endogenous response and accordingly, impairing the innate immunity, has become a challenge for the international scientific and medical community. Fortunately, recombinant interferons as therapeutic products have accumulated a long hist...
Article
Hyperinflammation distinguishes COVID-19 patients who develop a slight disease or none, from those progressing to severe and critical conditions. CIGB-258 is a therapeutic option for the latter group of patients. This drug is an altered peptide ligand (APL) derived from the cellular stress protein 60 (HSP60). In preclinical models, this peptide dev...
Article
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The instrumental role of CK2 in the SARS-CoV-2 infection has pointed out this protein kinase as promising therapeutic target in COVID-19. Anti-SARS-CoV-2 activity has been reported by CK2 inhibitors in vitro; however, no anti-CK2 clinical approach has been investigated in COVID-19. This trial aimed to explore the safety and putative clinical benefi...
Article
Introducción: El CIGB-258 es un péptido inmunomodulador con propiedades antiinflamatorias. Objetivos: Establecer la frecuencia de dosis y el tiempo de tratamiento con el péptido CIGB-258, para pacientes críticos con COVID-19. Además, definir los criterios de uso y el esquema terapéutico del péptido, para pacientes graves con COVID-19. Métodos: Se...
Article
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Insulin plays a major neuroprotective and trophic function for cerebral cell population, thus countering apoptosis, beta-amyloid toxicity, and oxidative stress; favoring neuronal survival; and enhancing memory and learning processes. Insulin resistance and impaired cerebral glucose metabolism are invariantly reported in Alzheimer's disease (AD) and...
Preprint
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Purpose: The instrumental role of CK2 in the SARS-Cov2 infection has pointed out this protein kinase as a promising therapeutic target in Covid-19. Anti-SARS-Cov2 activity has been reported by CK2 inhibitors in vitro; however, any anti-CK2 clinical approach has been investigated in Covid-19. This exploratory trial aimed to explore safety and putati...
Preprint
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Hepatic encephalopathy is a complex life-threatening neuropsychiatric syndrome, which can be associated with acute inflammation. It can be found in cases of acute liver failure caused by a viral infection. Reports of patients infected with SARS-CoV-2 have described hepatic encephalopathy. Therapy with immunomodulators can be an effective choice for...
Article
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Diabetes is constantly increasing at a rate that outpaces genetic variation and approaches to pandemic magnitude. Skin cells physiology and the cutaneous healing response are progressively undermined in diabetes which predisposes to lower limb ulceration, recidivism, and subsequent lower extremities amputation as a frightened complication. The mole...
Preprint
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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...
Article
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Lower-extremity diabetic ulcers are responsible for 80% of annual worldwide nontraumatic amputations. Epidermal growth factor (EGF) reduction is one of the molecular pillars of diabetic ulcer chronicity, thus EGF administration may be considered a type of replacement therapy. Topical EGF ad-ministration to improve and speed wound healing began in 1...
Preprint
Full-text available
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...
Preprint
Full-text available
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...
Article
Insulin resistance is a major underlying and preexisting event in chronic metabolic disorders. However, this is also an acute, de novo condition in critical burn survivors and other emergency episodes. Irrespective to its proximal trigger in burn pathology, peripheral insulin resistance results from an impaired receptor’s signaling to accurately tr...
Article
Diabetic foot ulcer is one of the most frightened diabetic complications leading to amputation disability and early mortality. Diabetic wounds exhibit a complex networking of inflammatory cytokines, local proteases, and reactive oxygen and nitrogen species as a pathogenic polymicrobial biofilm, overall contributing to wound chronification and host...
Article
Full-text available
Dengue is one of the most important diseases transmitted by mosquitoes. Dengvaxia®, a vaccine registered in several countries, cannot be administered to non-immune individuals and children younger than 9 years old, due to safety reasons. There are two vaccine candidates in phase 3 efficacy trials, but their registration date is completely unknown a...
Article
The development of live-attenuated vaccines against Dengue virus (DENV) has been problematic. Dengvaxia, licensed in several countries where DENV is endemic, has shown low efficacy profiles and there are safety concerns prohibiting its administration to children younger than 9 years old, and the live-attenuated tetravalent vaccine (LATV) developed...
Article
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Heberprovac is a GnRH based vaccine candidate containing 2.4 mg of the GnRHm1-TT peptide as the main active principle; 245 μg of the very small size proteoliposomes adjuvant (VSSP); and 350 μL of Montanide ISA 51 VG oil adjuvant. The aim of this study was to assess the safety and tolerance of the Heberprovac in advanced prostate cancer patients as...
Article
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The development of an effective and safe vaccine against the Dengue virus has been limited by the absence of a definite correlate of protection, together with the possibility of amplification of the viral infection by the neutralizing antibody response of low affinity and concentration. However, the cellular immune response offers possibilities to...
Article
Introduction: Dengue fever remains a health problem worldwide. Although the vaccine developed by Sanofi Pasteur, Dengvaxia®, has been registered in several countries, the results following the immunization of thousands of people suggest an increased risk in non-immune persons and children younger than 9 years old. No other vaccine is registered so...
Article
Diabetes mellitus remains with an ever-increasing prevalence, indefectibly associated to progressive and irreversible complications. Diabetic lower extremities ulcerations contribute to amputations, disability, and mortality. Ulcers result from a wound healing failure characterized by proliferative arrest, apoptosis, and senescence of granulation t...
Article
Full-text available
This paper describes for the first time the generation of the K88ab-GnRH hybrid fimbriae, the fusion of N. meningitidis P64k protein (P64k-GnRH), and its evaluation as vaccine candidates to control fertility in mammals. Twenty hybrid male pigs were randomly distributed in four groups: placebos and immunized with K88ab-GnRH, P64k-GnRH and a GnRH ana...
Article
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Context Current drugs for chronic hepatitis B therapy have a poor efficacy in terms of post-treatment sustained viral suppression and generate important side effects during and after therapy. Therapeutic vaccination with HBV antigens is an attractive alternative to test. Objective Evaluating the efficacy of a therapeutic vaccine candidate (designa...
Data
ANNEX 2 Biochemistry and liver function tests.doc. The file contains the results of Biochemistry and liver function tests of the timepoint assessments included in the publication. (DOC)
Data
ANNEX 1 Virology HBs HBeAg Serology.doc. The file contains the results of Virological and serological evaluations of the timepoint assessments included in the publication. (DOC)
Data
ANNEX 3 Adverse Events.doc to your manuscript. The file contains the results of adverse events detected during the study. (DOC)
Data
Minimal anonymized data set: Introduction. The file includes the following information: Statement on informed consent for data publication; Information regarding the variables used in the study, statistical hypothesis and justification of the sample size; and the Nature of the files used to provide the data in the Anonymized data set. (DOCX)
Article
Stopping long-term nucleos(t)ide analogue therapy increases HBsAg loss rates in HBeAg-negative patients. Viral rebound may induce immune responses facilitating functional cure. We analyzed which factors are associated with timing of virological relapse in 220 Asian HBeAg-negative patients from the prospective ABX203 vaccine study. Unexpectedly, onl...
Article
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Aim: This research focused on the results of the cross-validation program related with the performance of a Cuban novel low-cost real-time quantitative polymerase chain reaction (qPCR) assay for hepatitis B virus (HBV) quantification developed by the Therapeutic Vaccine against Hepatitis B Department, Vaccines Division, Center for Genetic Engineer...