Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate

▴ Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate
Janssen will aim to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States

The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants.

ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide.

In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate for the prevention of COVID-19 in up to 30,000 participants worldwide. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel.

While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen's COVID-19 vaccine program has been designed to be extremely thorough and driven by science. As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy.

The Phase 3 ENSEMBLE and ENSEMBLE 2 trials follow positive interim results from the Company's ongoing Phase 1/2a clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.

Tags : #JohnsonandJohnson #CovidVaccineNewsNov30 #Ensemblestudy #JNJ78436735

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Sexual wellness superstore, Love Depot launches digital campaign to deliver every desireMarch 28, 2024
Recharge Your Life: Simple Ways to Boost Your Physical and Mental EnergyMarch 28, 2024
The Neurological Toll of Common Household Chemicals: Insights from Recent ResearchMarch 28, 2024
The Aging Puzzle: Decoding the Mechanisms of AgingMarch 28, 2024
The Double-Edged Sword of Kala-azar Treatment: Shedding Light on Eye ComplicationsMarch 28, 2024
FTCCI Launches Industry-Academia Connect to improve the employability of Engineering Graduates and address the growing demand for Talent in Emerging TechMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
NTT and Olympus Begin World's First Joint Demonstration Experiment of Cloud Endoscopy SystemMarch 27, 2024
2nd Edition of IIFL JITO Ahimsa Run for peace & for non-violence to be held on 31st MarchMarch 27, 2024
Brij Hotels Announced 4 Million in Series A Funding March 27, 2024
Combatting Childhood Sedentariness: The Key to Preventing Premature Vascular DamageMarch 27, 2024
Crucial Findings: Unlocking Paths to Combat Ebola's DevastationMarch 27, 2024
Guarding Against Disease: The Crucial Role of Oral Hygiene in Preventive HealthcareMarch 27, 2024
Sanofi & Cipla announce exclusive distribution partnership to expand reach of CNS portfolio in IndiaMarch 26, 2024
Surmandal's Tribute to the Legends of Hindustani Classical MusicMarch 26, 2024
In Moscow, over 350,000 mammograms have been analyzed using artificial intelligence as part of the compulsory health insurance programMarch 26, 2024
Embark on a Creative Journey: "Kala For A Cause" Unveils Pottery Workshop Series March 26, 2024
Healthtech pioneer Aurora Innovation appoints new CEO – expands in Europe with service that streamlines patient-healthcare interactionMarch 26, 2024
In A Rare Feat, 45 YO Woman Walks Within 6 Hrs. Of Dual Robotic Surgery In A Single Operation At HCGMCCMarch 26, 2024
Improve Cancer Care through Automated CT Analysis: Oncoshield – CTMarch 26, 2024