NCT05329220 is a Phase 3 clinical trial of ABNCoV2 in COVID-19 Disease, sponsored by Bavarian Nordic.

Who is sponsoring NCT05329220?

NCT05329220 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT05329220?

Interventions in NCT05329220: ABNCoV2, Comirnaty.

What condition does NCT05329220 study?

NCT05329220 studies COVID-19 Disease.

Is NCT05329220 still recruiting?

NCT05329220 is currently completed. Last updated 24 February 2025.

Are results published for NCT05329220?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-24 · How we verify

NCT05329220

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 24 February 2025

What this trial tests

Phase 3 trial testing ABNCoV2 in COVID-19 Disease in 4,205 participants. Completed in 5 October 2023.

Timeline

30 August 2022

Primary endpoint
15 March 2023

5 October 2023

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	4,205
Start date	30 August 2022
Primary completion	15 March 2023
Estimated completion	5 October 2023
Sites	57 locations across Belgium, Denmark, United States

Drugs / interventions tested

ABNCoV2 — full drug profile →
Comirnaty (BNT162b2 (tozinameran)) — full drug profile →

Conditions studied

COVID-19 Disease — all drugs for COVID-19 Disease →

Sponsor

Bavarian Nordic — full company profile →

Who can join

18 and older, any sex, with COVID-19 Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination Primary · 2 weeks after the single trial vaccination occurring on Day 1

The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	1018.1	621.1 – 1669.0
Part A Cohort 1 Comirnaty	1060.6	708.2 – 1588.3
Part A Cohort 2 ABNCoV2	1259.0	1125.3 – 1408.4
Part A Cohort 2 Comirnaty	1619.6	1485.9 – 1765.4

Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination Secondary · 2 weeks after the single trial vaccination occurring on Day 1

The secondary endpoint was SARS-CoV-2 variants of concern (Omicron Variant BA.4/BA.5 and XBB.1.5) pseudovirus or virus neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination.

Omicron Variant BA.4/BA.5

Group	Value	95% CI
Part A Cohort 2 ABNCoV2	17112.6	14775.8 – 19818.9
Part A Cohort 2 Comirnaty	23506.3	20794.5 – 26571.7

Omicron Variant XBB.1.5

Group	Value	95% CI
Part A Cohort 2 ABNCoV2	54.7	48.9 – 61.3
Part A Cohort 2 Comirnaty	81.3	73.1 – 90.4

Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination. Secondary · Active trial period is from vaccination until 28 to 35 days after vaccination. Entire trial period is from vaccination until 182 to 196 days after vaccination. Solicited events are reported if occurring within 8 days following vaccination.

The number and percent of subjects who report: * SAEs or AESIs assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up. * Grade 3 or higher AEs assessed as related to trial vaccine in the 8 day period starting with the day of vaccination. * SAEs, AESIs or MAAEs, regardless of relationship, during the active trial phase. * SAE, AESI or MAAEs, regardless of relationship, during the entire trial period. * Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase. * Solicited local AEs in the 8 da

Related SAEs during Entire Trial Period

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	0
Part A Cohort 1 Comirnaty	0
Part A Cohort 2 ABNCoV2	0
Part A Cohort 2 Comirnaty	0
Part B Cohort 1 ABNCoV2	0
Part B Cohort 2 ABNCoV2	0

Related AESIs during Entire Trial Period

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	0
Part A Cohort 1 Comirnaty	0
Part A Cohort 2 ABNCoV2	3
Part A Cohort 2 Comirnaty	0
Part B Cohort 1 ABNCoV2	6
Part B Cohort 2 ABNCoV2	7

Related Grade 3 or Higher AEs within 8 Days of Vaccination

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	7
Part A Cohort 1 Comirnaty	2
Part A Cohort 2 ABNCoV2	28
Part A Cohort 2 Comirnaty	24
Part B Cohort 1 ABNCoV2	164
Part B Cohort 2 ABNCoV2	188

SAE, AESI, or MAAE during Active Trial Period

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	1
Part A Cohort 1 Comirnaty	3
Part A Cohort 2 ABNCoV2	42
Part A Cohort 2 Comirnaty	30
Part B Cohort 1 ABNCoV2	96
Part B Cohort 2 ABNCoV2	204

SAE, AESI, or MAAE during Entire Trial Period

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	6
Part A Cohort 1 Comirnaty	6
Part A Cohort 2 ABNCoV2	85
Part A Cohort 2 Comirnaty	78
Part B Cohort 1 ABNCoV2	192
Part B Cohort 2 ABNCoV2	442

Related Grade 3 or Higher AEs during Active Trial Period

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	7
Part A Cohort 1 Comirnaty	3
Part A Cohort 2 ABNCoV2	35
Part A Cohort 2 Comirnaty	34
Part B Cohort 1 ABNCoV2	218
Part B Cohort 2 ABNCoV2	272

Solicited Local AE within 8 Days of Vaccination

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	28
Part A Cohort 1 Comirnaty	30
Part A Cohort 2 ABNCoV2	238
Part A Cohort 2 Comirnaty	236
Part B Cohort 1 ABNCoV2	810
Part B Cohort 2 ABNCoV2	1269

Solicited Systemic AE within 8 Days of Vaccination

Group	Value	95% CI
Part A Cohort 1 ABNCoV2	23
Part A Cohort 1 Comirnaty	17
Part A Cohort 2 ABNCoV2	185
Part A Cohort 2 Comirnaty	170
Part B Cohort 1 ABNCoV2	715
Part B Cohort 2 ABNCoV2	1139

Adverse events — posted to ClinicalTrials.gov

Time frame: Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A Cohort 1 ABNCoV2

Serious: 2/34 (6%)

Deaths: 0/34

Part A Cohort 1 Comirnaty

Serious: 0/34 (0%)

Deaths: 0/34

Part A Cohort 2 ABNCoV2

Serious: 3/277 (1%)

Deaths: 1/277

Part A Cohort 2 Comirnaty

Serious: 7/277 (3%)

Deaths: 1/277

Part B Cohort 1 ABNCoV2

Serious: 23/1438 (2%)

Deaths: 0/1438

Part B Cohort 2 ABNCoV2

Serious: 49/2145 (2%)

Deaths: 1/2145

Serious adverse events (89 terms)

Reaction	System	Part A Cohort 1 ABNCoV2	Part A Cohort 1 Comirnaty	Part A Cohort 2 ABNCoV2	Part A Cohort 2 Comirnaty	Part B Cohort 1 ABNCoV2	Part B Cohort 2 ABNCoV2
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Abdominal wall abscess	Infections and infestations	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—
Arthritis bacterial	Infections and infestations	—	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—	—
Helicobacter infection	Infections and infestations	—	—	—	—	—	—
Large intestine infection	Infections and infestations	—	—	—	—	—	—
Liver abscess	Infections and infestations	—	—	—	—	—	—
Pelvic inflammatory disease	Infections and infestations	—	—	—	—	—	—
Perirectal abscess	Infections and infestations	—	—	—	—	—	—
Dengue fever	Infections and infestations	—	—	—	—	—	—
Intervertebral discitis	Infections and infestations	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Part A Cohort 1 ABNCoV2	Part A Cohort 1 Comirnaty	Part A Cohort 2 ABNCoV2	Part A Cohort 2 Comirnaty	Part B Cohort 1 ABNCoV2	Part B Cohort 2 ABNCoV2
COVID-19	Infections and infestations	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—

Most-reported serious reactions: Urinary tract infection, Atrial fibrillation, Hyperkalaemia, Sepsis, Pneumonia, Cerebrovascular accident, Syncope, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT05329220 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

First-in-human use of a modular capsid virus-like vaccine platform: an open-label, non-randomised, phase 1 clinical trial of the SARS-CoV-2 vaccine ABNCoV2.
Smit MJ, Sander AF, Ariaans MBPA, Fougeroux C, et al · · 2023 · cited 29× · PMID 36681093 · DOI 10.1016/s2666-5247(22)00337-8
Aspects of Phage-Based Vaccines for Protein and Epitope Immunization.
Palma M. · · 2023 · cited 20× · PMID 36851313 · DOI 10.3390/vaccines11020436
Protein Nanoparticles as Vaccine Platforms for Human and Zoonotic Viruses.
Pandey KK, Sahoo BR, Pattnaik AK. · · 2024 · cited 14× · PMID 38932228 · DOI 10.3390/v16060936
A perspective on SARS-CoV-2 virus-like particles vaccines.
Gao X, Xia Y, Liu X, Xu Y, et al · · 2023 · cited 14× · PMID 36649673 · DOI 10.1016/j.intimp.2022.109650
Development of a Tag/Catcher-mediated capsid virus-like particle vaccine presenting the conserved <i>Neisseria gonorrhoeae</i> SliC antigen that blocks human lysozyme.
Martinez FG, Zielke RA, Fougeroux CE, Li L, et al · · 2023 · cited 12× · PMID 37916806 · DOI 10.1128/iai.00245-23
Bacteriophage T4 as a Protein-Based, Adjuvant- and Needle-Free, Mucosal Pandemic Vaccine Design Platform.
Zhu J, Tao P, Chopra AK, Rao VB. · · 2024 · cited 10× · PMID 38768614 · DOI 10.1146/annurev-virology-111821-111145
Respiratory Viruses and Virus-like Particle Vaccine Development: How Far Have We Advanced?
Chu KB, Quan FS. · · 2023 · cited 10× · PMID 36851606 · DOI 10.3390/v15020392
Freeze-Drying of a Capsid Virus-like Particle-Based Platform Allows Stable Storage of Vaccines at Ambient Temperature.
Aves KL, Janitzek CM, Fougeroux CE, Theander TG, et al · · 2022 · cited 10× · PMID 35745873 · DOI 10.3390/pharmaceutics14061301

Verify or expand the search:

Other Bavarian Nordic trials

Trials by the same sponsor.

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NCT05065983 — A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05329220 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
Last refreshed: 24 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05329220.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing