This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

The ABNCoV2 COVID-19 Booster Vaccine Trial

Trial ID: NCT05329220
In this trial, we want to see if the trial booster vaccine, called ABNCoV2, can help protect adults against COVID-19.

Trial Details

The ABNCoV2 trial is a randomized, double-blind, phase 3 trial to assess the safety of ABNCoV2 and how well it works as a booster shot for COVID-19 in adults 65 years or older. ABNCoV2 is being developed as a universal booster, which means it can be used after any other type of previous COVID-19 vaccination or booster.

Participants will be in this trial for about 28 weeks (about 7 months). After getting a shot of a trial vaccine, participants will need to complete scheduled visits to a trial clinic for trial procedures and follow-up. Participants will also be tested for COVID 19 by RT-PCR at the start of the trial and if they have any COVID-19 symptoms after getting a shot of a trial vaccine. A follow-up telephone call will also be made to check for any side effects or symptoms that the participants may be having.

Estimated Enrollment

4000 Participants



Eligibility Criteria

Participants must:

  • Be at least 65 years and older
  • Male of Female
  • Have received a COVID-19 vaccine for primary vaccination and consider receiving a first or second booster
  • Be willing to sign an Informed Consent document
  • Be in general good health

Participants must not:

  • Test positive for COVID-19 at the start of the trial or have a history of COVID-19 infection within the last 3 months before joining the trial
  • Have a previous shot of an unapproved vaccine for COVID-19

What Will Happen in THis Trial

You will need to travel to one of the trial clinics taking part in this clinical trial. Sites are located in the cities/states identified with the red pin:

Sites are located in the cities/states identified with the red pin:

What’s Involved

If you qualify to participate, you will read and sign a consent form and receive a guide with more information about trial visits.

In total, you will have about 7 trial clinic visits and a telephone call with the trial team throughout your participation in the trial. The ABNCoV2 trial includes:

  • Screening: up to 2 weeks
  • Vaccination day
  • Follow-up period: 1 to 6 months (including 1 telephone call at Month 2)

Trial Activities

Before you receive a trial vaccine, the trial doctors and staff will give you an examination, test you for COVID-19 infection, and ask you questions about your medical history, medications you are taking, and vaccines you have received. If you qualify, you will join either Part A or Part B of the trial.

Participants in Part A are randomly assigned (like the flip of a coin) to get a shot of either ABNCoV2 or Comirnaty (an approved vaccine for COVID-19). Neither you nor the trial team will know whether you received ABNCoV2 or Comirnaty. In Part B, all participants will get ABNCoV2 as a one-time booster shot.

After one dose of a trial vaccine, you will visit the trial clinic weekly for up to 2 weeks, then once at Week 4, Month 3, and Month 6. During these visits, trial doctors will give you a physical examination, perform blood draws to measure antibodies or immune cells in blood, and check for any side effects or COVID-19 symptoms, if you have any. You will also be asked to record your side effects or symptoms in a diary. A follow-up telephone call will happen once at Month 2 to check if you are having any side effects or symptoms.

You will have continuous care throughout the trial and be closely monitored for any changes in your health.

Frequently Asked Questions (FAQs)