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1.
Panminerva Med ; 63(3): 324-331, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1504553

ABSTRACT

BACKGROUND: New messenger RNA (mRNA) and adenovirus-based vaccines (AdV) against Coronavirus disease 2019 (COVID-19) have entered large scale clinical trials. Since healthcare professionals (HCPs) and armed forces personnel (AFP) represent a high-risk category, they act as a suitable target population to investigate vaccine-related side effects, including headache, which has emerged as a common complaint. METHODS: We investigated the side-effects of COVID-19 vaccines among HCPs and AFP through a 38 closed-question international survey. The electronic link was distributed via e-mail or via Whatsapp to more than 500 contacts. Responses to the survey questions were analyzed with bivariate tests. RESULTS: A total of 375 complete surveys have been analyzed. More than 88% received an mRNA vaccine and 11% received AdV first dose. A second dose of mRNA vaccine was administered in 76% of individuals. No severe adverse effects were reported, whereas moderate reactions and those lasting more than 1 day were more common with AdV (P=0.002 and P=0.024 respectively). Headache was commonly reported regardless of the vaccine type, but less frequently, with shorter duration and lower severity that usually experienced by participants, without significant difference irrespective of vaccine type. CONCLUSIONS: Both mRNA and AdV COVID-19 vaccines were safe and well tolerated in a real-life subset of HCPs and AFP subjects.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Headache/chemically induced , Vaccination/adverse effects , Adolescent , Adult , Aged , COVID-19/transmission , Cross-Sectional Studies , Female , Headache/diagnosis , Headache/epidemiology , Health Care Surveys , Health Personnel , Humans , Incidence , Male , Middle Aged , Occupational Health , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
2.
Clin Pharmacol Ther ; 110(6): 1467-1477, 2021 12.
Article in English | MEDLINE | ID: covidwho-1372711

ABSTRACT

Therapeutics for patients hospitalized with coronavirus disease 2019 (COVID-19) are urgently needed during the pandemic. Bamlanivimab is a potent neutralizing monoclonal antibody that blocks severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) attachment and entry into human cells, which could potentially lead to therapeutic benefit. J2W-MC-PYAA was a randomized, double-blind, sponsor unblinded, placebo-controlled, single ascending dose first-in-human trial (NCT04411628) in hospitalized patients with COVID-19. A total of 24 patients received either placebo or a single dose of bamlanivimab (700 mg, 2,800 mg, or 7,000 mg). The primary objective was assessment of safety and tolerability, including adverse events and serious adverse events, with secondary objectives of pharmacokinetic (PK) and pharmacodynamic analyses. Treatment-emergent adverse event (TEAE) rates were identical in the placebo and pooled bamlanivimab groups (66.7%). There were no apparent dose-related increases in the number or severity of TEAEs. There were no serious adverse events or deaths during the study, and no discontinuations due to adverse events. PKs of bamlanivimab is linear and exposure increased proportionally with dose following single i.v. administration. The half-life was ~ 17 days. These results demonstrate the favorable safety profile of bamlanivimab, and provided the initial critical evaluation of safety, tolerability, and PKs in support of the development of bamlanivimab in several ongoing clinical trials.


Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Antiviral Agents/administration & dosage , COVID-19/diagnosis , COVID-19/drug therapy , Hospitalization/trends , Administration, Intravenous , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , Antiviral Agents/adverse effects , COVID-19/immunology , Dose-Response Relationship, Drug , Double-Blind Method , Fatigue/chemically induced , Female , Headache/chemically induced , Humans , Male , Middle Aged
3.
Am J Clin Dermatol ; 22(5): 693-707, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1361347

ABSTRACT

BACKGROUND: Pivotal phase III studies demonstrated that abrocitinib, an oral, once-daily, JAK1-selective inhibitor, is effective treatment for moderate-to-severe atopic dermatitis (AD) as monotherapy and in combination with topical therapy. OBJECTIVE: The aim of this study was to evaluate the long-term safety of abrocitinib 200 mg and 100 mg in an integrated analysis of a phase IIb study, four phase III studies, and one long-term extension study. METHODS: Two cohorts were analyzed: a placebo-controlled cohort from 12- to 16-week studies and an all-abrocitinib cohort including patients who received one or more abrocitinib doses. Adverse events (AEs) of interest and laboratory data are reported. RESULTS: Total exposure in the all-abrocitinib cohort (n = 2856) was 1614 patient-years (PY); exposure was ≥ 24 weeks in 1248 patients and ≥ 48 weeks in 606 (maximum 108 weeks). In the placebo-controlled cohort (n = 1540), dose-related AEs (200 mg, 100 mg, placebo) were nausea (14.6%, 6.1%, 2.0%), headache (7.8%, 5.9%, 3.5%), and acne (4.7%, 1.6%, 0%). Platelet count was reduced transiently in a dose-dependent manner; 2/2718 patients (200-mg group) had confirmed platelet counts of < 50 × 103/mm3 at week 4. Incidence rates (IRs) were 2.33/100PY and 2.65/100 PY for serious infection, 4.34/100PY and 2.04/100PY for herpes zoster, and 11.83/100PY and 8.73/100PY for herpes simplex in the 200-mg and 100-mg groups, respectively. IRs for nonmelanoma skin cancer, other malignancies, and major adverse cardiovascular events were < 0.5/100PY for both doses. Five venous thromboembolism events occurred (IR 0.30/100PY), all in the 200-mg group. There were three deaths due to gastric carcinoma (diagnosed at day 43), sudden death, and COVID-19. CONCLUSION: Abrocitinib, with proper patient and dose selection, has a manageable tolerability and longer-term safety profile appropriate for long-term use in patients with moderate-to-severe AD. TRIAL REGISTRIES: ClinicalTrials.gov: NCT02780167, NCT03349060, NCT03575871, NCT03720470, NCT03627767, NCT03422822.


Subject(s)
Dermatitis, Atopic/drug therapy , Infections/epidemiology , Protein Kinase Inhibitors/adverse effects , Pyrimidines/adverse effects , Skin Neoplasms/epidemiology , Sulfonamides/adverse effects , Acne Vulgaris/chemically induced , Adolescent , Adult , Aged , Cardiovascular Diseases/epidemiology , Cholesterol, HDL/blood , Cholesterol, LDL/blood , Female , Headache/chemically induced , Herpes Simplex/epidemiology , Herpes Zoster/epidemiology , Humans , Incidence , Lymphocyte Count , Male , Middle Aged , Nausea/chemically induced , Platelet Count , Protein Kinase Inhibitors/administration & dosage , Pyrimidines/administration & dosage , Risk Factors , Sulfonamides/administration & dosage , Time Factors , Venous Thromboembolism/epidemiology , Young Adult
4.
Nat Commun ; 12(1): 4636, 2021 07 30.
Article in English | MEDLINE | ID: covidwho-1347938

ABSTRACT

Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks. Major concerns are the persistent and disabling polyarthralgia in infected individuals. Here we present the results from a first-in-human trial of the candidate simian adenovirus vectored vaccine ChAdOx1 Chik, expressing the CHIKV full-length structural polyprotein (Capsid, E3, E2, 6k and E1). 24 adult healthy volunteers aged 18-50 years, were recruited in a dose escalation, open-label, nonrandomized and uncontrolled phase 1 trial (registry NCT03590392). Participants received a single intramuscular injection of ChAdOx1 Chik at one of the three preestablished dosages and were followed-up for 6 months. The primary objective was to assess safety and tolerability of ChAdOx1 Chik. The secondary objective was to assess the humoral and cellular immunogenicity. ChAdOx1 Chik was safe at all doses tested with no serious adverse reactions reported. The vast majority of solicited adverse events were mild or moderate, and self-limiting in nature. A single dose induced IgG and T-cell responses against the CHIKV structural antigens. Broadly neutralizing antibodies against the four CHIKV lineages were found in all participants and as early as 2 weeks after vaccination. In summary, ChAdOx1 Chik showed excellent safety, tolerability and 100% PRNT50 seroconversion after a single dose.


Subject(s)
Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , Chikungunya Fever/immunology , Chikungunya virus/immunology , Viral Vaccines/immunology , Adolescent , Adult , Chikungunya Fever/prevention & control , Chikungunya Fever/virology , Chikungunya virus/classification , Chikungunya virus/physiology , Cytokines/immunology , Cytokines/metabolism , Enzyme-Linked Immunosorbent Assay , Fatigue/chemically induced , Female , Headache/chemically induced , Humans , Immunoglobulin G/immunology , Injections, Intramuscular , Male , Middle Aged , T-Lymphocytes/immunology , T-Lymphocytes/metabolism , Vaccination/methods , Viral Vaccines/administration & dosage , Viral Vaccines/adverse effects , Young Adult
5.
J Korean Med Sci ; 36(27): e196, 2021 Jul 12.
Article in English | MEDLINE | ID: covidwho-1308263

ABSTRACT

BACKGROUND: This is an observational study to analyze an emergency department (ED) utilization pattern of coronavirus disease 2019 (COVID-19) vaccinated in-hospital healthcare workers (HCWs). METHODS: We included 4,703 HCWs who were administered the first dose of the COVID-19 vaccine between March 4 and April 2, 2021, in a tertiary hospital in Korea where fast-track and post-vaccination cohort zone (PVCZ) were introduced in ED. We analyzed data of participants' age, sex, occupation, date and type of vaccination, and their clinical information using SPSS v25.0. RESULTS: The sample comprised HCWs, who received either the ChAdOx1 (n = 4,458) or the BNT162B2 (n = 245) vaccines; most participants were female (73.5%), and 81.1% were under 50 years old. Further, 153 (3.3%) visited the ED and reported experiencing fever (66.9%) and myalgia (56.1%). Additionally, 91 (59.5%) of them were in their 20s, and 106 (67.5%) were assigned to the PVCZ. Lastly, 107 (68.2%) of the patients received parenteral management. No patient required hospitalization. CONCLUSION: In conclusion, vaccinated HCWs who visited the ED with adverse events had a high incidence of fever and a low likelihood of developing serious illnesses. As the COVID-19 vaccination program for Korean citizens continues to expand, strategies to minimize unnecessary ED overcrowding should be put into effect.


Subject(s)
COVID-19 Vaccines/adverse effects , Emergency Service, Hospital/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Personnel, Hospital/statistics & numerical data , Vaccination/adverse effects , Adult , Antiemetics/therapeutic use , Antipyretics/therapeutic use , COVID-19 Testing/statistics & numerical data , Chills/chemically induced , Chills/epidemiology , Clinical Protocols , Emergency Service, Hospital/organization & administration , Female , Fever/chemically induced , Fever/drug therapy , Fever/epidemiology , Headache/chemically induced , Headache/epidemiology , Humans , Male , Middle Aged , Myalgia/chemically induced , Myalgia/epidemiology , Nausea/chemically induced , Nausea/drug therapy , Nausea/epidemiology , Patient Readmission/statistics & numerical data , Republic of Korea , Retrospective Studies , Software Design , Tertiary Care Centers/statistics & numerical data , Triage , Young Adult
6.
Expert Rev Vaccines ; 20(8): 1013-1025, 2021 08.
Article in English | MEDLINE | ID: covidwho-1284827

ABSTRACT

INTRODUCTION: Several vaccine candidates have been developed using different platforms, including nucleic acids (DNA and RNA), viral vectors (replicating and non-replicating), virus-like particles, peptide-based, recombinant proteins, live attenuated, and inactivated virus modalities. Although many of these vaccines are undergoing pre-clinical trials, several large clinical trials investigating the clinical efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines have produced promising findings. AREAS COVERED: In this review, we provide a status update on COVID-19 vaccines currently undergoing clinical trials and discuss issues of concern beyond vaccine efficacy and safety, including dosing regimens, the mixed vaccine strategy, prior severe acute respiratory syndrome coronavirus-2 infection, antibody levels, cellular immunity and protection, variants of concern, COVID-19 vaccine distribution, vaccination willingness, herd immunity, immunity passports, and vaccine indications. EXPERT OPINION: Four vaccines have obtained emergency use authorization, 87 are at the clinical development stage, and 186 are in pre-clinical development. While the knowledge and development of COVID-19 vaccines is rapidly expanding, the benefits of COVID-19 vaccines must outweigh the potential risks of adverse events. To combat the COVID-19 pandemic, clinicians should consistently update COVID-19-associated information, and healthcare authorities and manufacturers should work together to provide adequate and appropriate vaccinations for the prevention of COVID-19. PLAIN LANGUAGE SUMMARY: What is the context?Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) caused a global pandemic: the coronavirus disease 2019 (COVID-19) outbreak. The development and implementation of the COVID-19 vaccine could be an important measure to control the COVID-19 pandemic.What is new?Several phase 3 clinical trials have demonstrated the effectiveness and safety of COVID-19 vaccines for the prevention of SARS-CoV-2 infections. Several COVID-19 vaccines have obtained emergency use authorization and been implemented in many countries. Although concerns regarding unusual blood clots and low platelet counts have been raised, the benefits of COVID-19 vaccines outweigh the potential risks of adverse events.What is the impact?Except for children, the COVID-19 vaccine is recommended for all people, including those pregnant or immunocompromised. Healthcare authorities should advise people receiving the vaccine that they must seek medical attention if they have associated thromboembolism and thrombocytopenia symptoms. More studies are necessary to determine the appropriate vaccine dose and regimen strategy, as well as the effectiveness of COVID-19 vaccines against variants of concerns. A global effort must be made to achieve widespread vaccination and herd immunity.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Patient Safety , Animals , COVID-19/epidemiology , Clinical Trials, Phase III as Topic/methods , Fatigue/chemically induced , Female , Fever/chemically induced , Headache/chemically induced , Humans , Immunocompromised Host/drug effects , Immunocompromised Host/physiology , Male , Pregnancy , Randomized Controlled Trials as Topic/methods , Treatment Outcome
7.
Travel Med Infect Dis ; 36: 101812, 2020.
Article in English | MEDLINE | ID: covidwho-633889

ABSTRACT

BACKGROUND: Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No previous meta-analysis has evaluated its side effects versus placebo. We conducted this meta-analysis to compare the safety of HCQ versus placebo. METHODS: Two authors independently searched PubMed and EMBASE databases for randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs) were calculated based on random-effects models. The heterogeneity (I2) was assessed using Cochran's Q test. RESULTS: Nine RCTs (eight were double-blind) with a total of 916 patients were included. HCQ caused significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 19.00; P-value = 0.033; I2 = 0%). The increase in other AEs did not reach statistical significance: rash (Peto OR, 1.11; 95% CI, 0.3 to 3.77; P-value = 0.03; I2 = 0%); gastrointestinal AEs (Peto OR, 1.43; 95% CI, 0.55 to 3.72; P-value = 0.46; I2 = 15.17%); headache (Peto OR, 1.94; 95% CI, 0.65 to 5.78; P-value = 0.23; I2 = 9.99%); dizziness (Peto OR, 1.32; 95% CI, 0.49 to 3.52; P-value = 0.58; I2 = 0%); fatigue (Peto OR, 2.13; 95% CI, 0.76 to 5.98; P-value = 0.15; I2 = 0%); and visual AEs (Peto OR, 1.61; 95% CI, 0.76 to 3.41; P-value = 0.22; I2 = 0%). Cardiac toxicity was not reported. CONCLUSIONS: This meta-analysis of RCTs found a significantly higher risk of skin pigmentation in HCQ users versus placebo. More data are needed to evaluate HCQ in the context of COVID-19 treatment.


Subject(s)
Alzheimer Disease/drug therapy , Antirheumatic Agents/adverse effects , Chronic Urticaria/drug therapy , Glomerulonephritis, IGA/drug therapy , HIV Infections/drug therapy , Hydroxychloroquine/adverse effects , Hyperpigmentation/chemically induced , Rheumatic Diseases/drug therapy , Arthritis, Rheumatoid/drug therapy , Asymptomatic Infections , Betacoronavirus , COVID-19 , Coronavirus Infections/drug therapy , Dizziness/chemically induced , Exanthema/chemically induced , Fatigue/chemically induced , Gastrointestinal Diseases/chemically induced , Headache/chemically induced , Humans , Lupus Erythematosus, Cutaneous/drug therapy , Lupus Erythematosus, Systemic/drug therapy , Osteoarthritis/drug therapy , Pandemics , Pneumonia, Viral/drug therapy , Randomized Controlled Trials as Topic , SARS-CoV-2
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