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Virus Vaccine

ABNCoV2 for COVID-19

Phase 3
Waitlist Available
Research Sponsored by Bavarian Nordic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you 65 years of age and older?
Have you been fully vaccinated (primary vaccination) against COVID-19?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after vaccination
Awards & highlights

Study Summary

This trial is testing a new vaccine (ABNCoV2) against the current best vaccine (Comirnaty) to see if the new one is better. The trial is split into two parts. In the first part, a group of people will get the new vaccine and a group will get Comirnaty, and they will be compared. In the second part, a larger group of people will just get the new vaccine so that more safety and efficacy data can be collected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are 65 years old or older.
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You have received all required doses of the COVID-19 vaccine.
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Have you received one or two doses of the vaccine and are now considering getting an additional booster shot?
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Have you received a COVID-19 vaccine more than 3 months ago?
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You have not been diagnosed with COVID-19 in the last 3 months.
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You do not have a medical condition that weakens your immune system.
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You have never received an organ transplant.
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You have never had a rare heart condition called myocarditis or pericarditis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-inferiority, or superiority in terms of neutralizing antibodies against the SARS-CoV-2 index virus (Wuhan wild type isolate), in Part A Cohort 1 and 2
Secondary outcome measures
Neutralizing antibody titers against the SARS-CoV-2 index virus after vaccination with ABNCoV2
Non-inferiority, or superiority, in terms of neutralizing antibodies against SARS-CoV-2 variants of concern (VOCs).
Safety and tolerability of the ABNCoV2 vaccine as measured by the incidence of solicited and unsolicited adverse events occurring during or after the trial vaccination.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ABNCoV2 100μg single doseExperimental Treatment1 Intervention
ABNCoV2 100μg single dose
Group II: ComirnatyActive Control1 Intervention
Comirnaty

Find a Location

Who is running the clinical trial?

Bavarian NordicLead Sponsor
61 Previous Clinical Trials
45,705 Total Patients Enrolled
1 Trials studying COVID-19
197 Patients Enrolled for COVID-19
Leo James, MDStudy DirectorBavarian Nordic GmbH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does ABNCoV2 carry any long-term risks for patients?

"There is supporting evidence for ABNCoV2's efficacy and safety from multiple sources, so it received a score of 3."

Answered by AI

Can new patients sign up for this experiment?

"This clinical trial, which was first advertised onAugust 31st, is still recruiting patients. The listing was last updated on October 26th."

Answered by AI

How many places are participating in this research project?

"Accel Research Site - NeuroStudies.net, LLC in Decatur, Georgia, AES - DRS - Synexus Clinical Research US, Inc. in Evansville, Indiana, and Meridian Clinical Research , LLC in Grand Island, Nebraska are a few of the 29 locations running this trial."

Answered by AI

How many people are researchers testing this on at most?

"Yes, this is an ongoing clinical trial that was first posted on 8/31/2022 and has since enrolled 4000 patients at 29 different locations, according to the latest update on clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Other
Texas
How old are they?
18 - 65
What site did they apply to?
CBH Health - CenExel CBH
Suncoast Research Group LLC
DM Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I need the help. Want to be of help. My gift to the world. Covid prevention and money.
PatientReceived no prior treatments
To get a vac. For covid 19.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a phase 1 trial? How long does the trial last?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. PRI, LLC - Newport Beach - M3 WR: < 48 hours
  2. Tekton Research: < 48 hours
  3. Carolina Institute for Clinical Research: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
2022. "ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329220.
~1635 spots leftby Apr 2025
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