Johnson & Johnson COVID-19 Vaccine Trials Temporarily Paused Due to Unexplained Illness in Participant
|
By HospiMedica International staff writers Posted on 13 Oct 2020 |
|
Illustration
Johnson & Johnson (New Brunswick, NJ, USA) has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.
In September, the company had announced the launch of its large-scale, pivotal, multi-country Phase 3 ENSEMBLE trial for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial followed positive interim results from the company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. ENSEMBLE aims to enroll up to 60,000 volunteers across three continents, and study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.
However, according to a statement released by the company, an unexplained illness in a study participant had forced it to temporarily pause further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial. Johnson & Johnson has said that the participant’s illness was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as its internal clinical and safety physicians.
The company said that pre-specified guidelines for all its clinical studies ensure that the studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so that there can be a careful review of all of the medical information before deciding whether to restart the study. According to Johnson & Johnson, SAEs were not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. The company has said that it was learning more about the participant’s illness and would be able to share additional information only after gathering all the facts.
Related Links:
Johnson & Johnson
In September, the company had announced the launch of its large-scale, pivotal, multi-country Phase 3 ENSEMBLE trial for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial followed positive interim results from the company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. ENSEMBLE aims to enroll up to 60,000 volunteers across three continents, and study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.
However, according to a statement released by the company, an unexplained illness in a study participant had forced it to temporarily pause further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial. Johnson & Johnson has said that the participant’s illness was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as its internal clinical and safety physicians.
The company said that pre-specified guidelines for all its clinical studies ensure that the studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so that there can be a careful review of all of the medical information before deciding whether to restart the study. According to Johnson & Johnson, SAEs were not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. The company has said that it was learning more about the participant’s illness and would be able to share additional information only after gathering all the facts.
Related Links:
Johnson & Johnson
New
Gold Member
Handheld Blood Glucose Analyzer
STAT-Site
New
Surgical Dressing
ALLEVYN Ag+ SURGICAL
New
Gas Analyzer
GE SAM
Latest COVID-19 News
- Low-Cost System Detects SARS-CoV-2 Virus in Hospital Air Using High-Tech Bubbles
- World's First Inhalable COVID-19 Vaccine Approved in China
- COVID-19 Vaccine Patch Fights SARS-CoV-2 Variants Better than Needles
- Blood Viscosity Testing Can Predict Risk of Death in Hospitalized COVID-19 Patients
- ‘Covid Computer’ Uses AI to Detect COVID-19 from Chest CT Scans
- MRI Lung-Imaging Technique Shows Cause of Long-COVID Symptoms
- Chest CT Scans of COVID-19 Patients Could Help Distinguish Between SARS-CoV-2 Variants
- Specialized MRI Detects Lung Abnormalities in Non-Hospitalized Long COVID Patients
- AI Algorithm Identifies Hospitalized Patients at Highest Risk of Dying From COVID-19
- Sweat Sensor Detects Key Biomarkers That Provide Early Warning of COVID-19 and Flu
- Study Assesses Impact of COVID-19 on Ventilation/Perfusion Scintigraphy
- CT Imaging Study Finds Vaccination Reduces Risk of COVID-19 Associated Pulmonary Embolism
- Third Day in Hospital a ‘Tipping Point’ in Severity of COVID-19 Pneumonia
- Longer Interval Between COVID-19 Vaccines Generates Up to Nine Times as Many Antibodies
- AI Model for Monitoring COVID-19 Predicts Mortality Within First 30 Days of Admission
- AI Predicts COVID Prognosis at Near-Expert Level Based Off CT Scans
Channels
Artificial Intelligence
view channel
Machine Learning Approach Enhances Liver Cancer Risk Stratification
Hepatocellular carcinoma, the most common form of primary liver cancer, is often detected late despite targeted surveillance programs. Current screening guidelines emphasize patients with known cirrhosis,... Read more
New AI Approach Monitors Brain Health Using Passive Wearable Data
Brain health spans cognitive and emotional functions and can fluctuate even in adults without diagnosed disease. Detecting early changes remains difficult in routine care and burdens specialty services... Read more
Critical Care
view channel
Automated IV Labeling Solution Improves Infusion Safety and Efficiency
Medication administration in high-acuity settings is often complicated by multiple concurrent infusions, making accurate line identification essential. In a 10-hospital intensive care unit study, 60% of... Read more
First-Of-Its-Kind AI Tool Detects Pulmonary Hypertension from Standard ECGs
Pulmonary hypertension is a progressive, life‑threatening disease that is frequently missed early because symptoms such as dyspnea are nonspecific and diagnostic delays can exceed two years.... Read more
Surgical Techniques
view channel
Continuous Monitoring with Wearables Enhances Postoperative Patient Safety
Postoperative hypoxemia on general surgical wards is common and often missed by intermittent vital sign checks. Undetected low oxygen levels can delay recovery and raise the risk of complications that... Read more
New Approach Enables Customized Muscle Tissue Without Biomaterial Scaffolds
Volumetric muscle loss is a traumatic loss of skeletal muscle that often leads to permanent functional impairment and limited reconstructive options. Current experimental strategies struggle to deliver... Read more
Patient Care
view channel
Wearable Sleep Data Predict Adherence to Pulmonary Rehabilitation
Chronic obstructive pulmonary disease (COPD) is a long-term lung disorder that makes breathing difficult and often disturbs sleep, reducing energy for daily activities. Limited engagement in pulmonary... Read more
Revolutionary Automatic IV-Line Flushing Device to Enhance Infusion Care
More than 80% of in-hospital patients receive intravenous (IV) therapy. Every dose of IV medicine delivered in a small volume (<250 mL) infusion bag should be followed by subsequent flushing to ensure... Read more
Health IT
view channel
EMR-Based Tool Predicts Graft Failure After Kidney Transplant
Kidney transplantation offers patients with end-stage kidney disease longer survival and better quality of life than dialysis, yet graft failure remains a major challenge. Although a successful transplant... Read more
Printable Molecule-Selective Nanoparticles Enable Mass Production of Wearable Biosensors
The future of medicine is likely to focus on the personalization of healthcare—understanding exactly what an individual requires and delivering the appropriate combination of nutrients, metabolites, and... Read more
Business
view channel
GE HealthCare Leads Major European Initiative to Advance Cardio-Oncology Care
Cardiovascular complications are increasingly recognized among people undergoing or recovering from cancer treatment, driven by pre‑existing disease and the cardiotoxic effects of chemotherapy, radiotherapy,... Read more
