Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05329220

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2

COVID-19 Disease Clinical Trial

Official title:
Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts-Randomized, Double-blind, Active Controlled and Open-label, Single-arm

Clinical Trial Summary

This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty. Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05329220
Study type Interventional
Source Bavarian Nordic
Contact
Status Completed
Phase Phase 3
Start date August 31, 2022
Completion date October 5, 2023
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04984408 - Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. Phase 3
Terminated NCT04642638 - Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure Phase 2/Phase 3
Recruiting NCT04587323 - VEGF and sFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease
Completed NCT04682873 - A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19, Caused by the SARS-CoV-2 Virus Phase 3
Completed NCT04359212 - Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19
Completed NCT05603130 - Epidemiologic Register on Diabetes and COVID-19 in Tunisia
Completed NCT04830800 - A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC Phase 1/Phase 2
Completed NCT04757792 - Back to the Traditional: Anti-COX Drugs Can Improve the Outcome of COVID-19 Patients Admitted to ICU
Active, not recruiting NCT04417257 - Study of LAU-7b for the Treatment of COVID-19 Disease in Adults Phase 2/Phase 3
Recruiting NCT04522037 - Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients
Completed NCT04446377 - A Study of LAM-002A for the Prevention of Progression of COVID-19 Phase 2
Active, not recruiting NCT04969172 - A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection Phase 2
Completed NCT04347369 - A Retrospective Study of Neural Network Model to Dynamically Quantificate the Severity in COVID-19 Disease
Completed NCT04366024 - A Novel Nomogram to Predict Severity of COVID-19
Completed NCT04787510 - COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection
Active, not recruiting NCT05077267 - ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects Phase 2
Completed NCT04472013 - Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19
Active, not recruiting NCT04371354 - Outcomes of Covid-19 Protective Measures in Endoscopy
Not yet recruiting NCT04779359 - Role of Lymphocyte Subsets and Laboratory Measurements in COVID-19 Disease