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Clinical Trial Results:
An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.

Summary
EudraCT number	2021-001393-31
Trial protocol	DE
Global end of trial date	31 Oct 2023

Results information
Results version number	v1(current)
This version publication date	19 Sep 2024
First version publication date	19 Sep 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

ABNCoV2-01

ISRCTN number

US NCT number

NCT05077267

WHO universal trial number (UTN)

Sponsor organisation name

Bavarian Nordic A/S

Sponsor organisation address

Philip Heymans Alle 3, Hellerup, Denmark, 2900

Public contact

clinical-mailbox, Bavarian Nordic GmbH, clinical-mailbox@bavarian-nordic.com

Scientific contact

clinical-mailbox, Bavarian Nordic GmbH, clinical-mailbox@bavarian-nordic.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Dec 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Feb 2022

Global end of trial reached?

Yes

Global end of trial date

31 Oct 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess SARS-CoV-2 specific humoral immune responses of the ABNCoV2 vaccine in initially SARS-CoV-2 seronegative and seropositive subjects.

Protection of trial subjects

The Data Monitoring Committee (DMC) is an independent board that oversees the safety of subjects participating in the trial. The members of the DMC are independent experts with experience in infectious diseases. The primary responsibility of the DMC is to review and evaluate the accumulated trial safety data and make recommendations to proceed to open enrollment for remaining subjects. If an event occurs which fulfills the trial halting rules, the DMC will review the event in a timely manner and agree on a recommendation to halt, resume or terminate the trial participation of the affected subject(s) and/or the trial as a whole. A temporary halting or termination for the trial as a whole can be decided in case of: • a SAE with an at least reasonable possibility of a causal relationship to the administration of ABNCoV2 vaccine • an unexpected Grade 3 or higher systemic reaction or lab toxicity with at least a reasonable possibility of a causal relationship to the administration of ABNCoV2 vaccine These parameters are not all-inclusive. Other AEs could occur that would trigger a DMC review. Any member of the DMC, the Principal Investigator and/or the Bavarian Nordic Medical Monitor or safety physician could request a DMC review based on any observation.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Aug 2021

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 197

Worldwide total number of subjects

197

EEA total number of subjects

197

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

165

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Approximately 210 subjects were to be enrolled at 2 clinical trial sites in Germany.

Screening details

The trial began with a run-in phase of 6 subjects (3 in each of Groups 1 and 2) before enrollment opened to both treatment groups pending positive results from a safety Data Monitoring Committee. Enrollment was based on prior SARS-CoV-2 experience, with Group 1 being seronegative and Groups 2 and 3 being seropositive.

Period 1 title

Treatment Period

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Group 1

Arm description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 100ug to doses, Day 1 and Day 29

Group 2

Arm description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 100ug single dose.

Group 3

Arm description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 50ug single dose.

Number of subjects in period 1	Group 1	Group 2	Group 3
Started	28	103	66
Completed	28	101	66
Not completed	0	2	0
Consent withdrawn by subject	-	1	-
Lost to follow-up	-	1	-

Period 2 title

Follow-up Period

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Group 1

Arm description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 100ug to doses, Day 1 and Day 29

Group 2

Arm description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 100ug single dose.

Group 3

Arm description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Arm type

Experimental

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 100ug single dose.

Investigational medicinal product name

ABNCoV2

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intramuscular use

Dosage and administration details

ABNCoV2 50ug single dose.

Number of subjects in period 2	Group 1	Group 2	Group 3
Started	28	101	66
Completed	28	3	0
Not completed	0	98	66
Consent withdrawn by subject	-	1	5
Received COVID-19 booster outside of trial	-	66	30
PATIENT IS BUSY AT WORK AND WITHDRAWS THE IC	-	-	1
Trial Terminated by Sponsor	-	27	23
Lost to follow-up	-	4	7

Baseline characteristics

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Reporting group title

Group 1

Reporting group description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Reporting group title

Group 2

Reporting group description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group title

Group 3

Reporting group description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group values	Group 1	Group 2	Group 3	Total
Number of subjects	28	103	66	197
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	27	79	59	165
From 65-84 years	1	24	7	32
85 years and over	0	0	0	0
Gender categorical
Units: Subjects
Female	17	42	33	92
Male	11	61	33	105

End points

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Reporting group title

Group 1

Reporting group description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Reporting group title

Group 2

Reporting group description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group title

Group 3

Reporting group description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group title

Group 1

Reporting group description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Reporting group title

Group 2

Reporting group description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group title

Group 3

Reporting group description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Primary: SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

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End point title

SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination ^[1]

End point description

The primary endpoint was SARS-CoV-2 index virus neutralizing antibody titers by pseudovirus assay at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3), for subjects in the Immunogenicity Analysis Set.

End point type

Primary

End point timeframe

2 weeks after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: There were no planned statistical comparisons between groups for this open-label, phase 2 trial.

End point values	Group 1	Group 2	Group 3
Number of subjects analysed	24	99	65
Units: titer
geometric mean (confidence interval 95%)	516.7 (309.0 to 864.0)	970.9 (804.1 to 1172.3)	978.9 (781.0 to 1226.8)

No statistical analyses for this end point

Secondary: Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

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End point title

Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

End point description

Subjects reporting any serious adverse events (SAEs) or adverse events of special interest (AESIs) assessed as related to trial vaccine within 8 days after vaccination

End point type

Secondary

End point timeframe

Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.

End point values	Group 1	Group 2	Group 3
Number of subjects analysed	28	103	66
Units: Subjects	0	0	0

No statistical analyses for this end point

Secondary: Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

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End point title

Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

End point description

Subjects reporting any Grade ≥ 3 adverse events (AEs) assessed as related to trial vaccine within 8 days after vaccination

End point type

Secondary

End point timeframe

Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.

End point values	Group 1	Group 2	Group 3
Number of subjects analysed	28	103	66
Units: Subjects	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Group 1

Reporting group description

Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29

Reporting group title

Group 2

Reporting group description

Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1

Reporting group title

Group 3

Reporting group description

Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1

Serious adverse events	Group 1	Group 2	Group 3
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 28 (0.00%)	5 / 103 (4.85%)	1 / 66 (1.52%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	0 / 28 (0.00%)	0 / 103 (0.00%)	1 / 66 (1.52%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Foot fracture
subjects affected / exposed	0 / 28 (0.00%)	2 / 103 (1.94%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 28 (0.00%)	1 / 103 (0.97%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	0 / 28 (0.00%)	1 / 103 (0.97%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrioventricular block complete
subjects affected / exposed	0 / 28 (0.00%)	1 / 103 (0.97%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 28 (0.00%)	1 / 103 (0.97%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 28 (0.00%)	1 / 103 (0.97%)	0 / 66 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 1	Group 2	Group 3
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 28 (35.71%)	7 / 103 (6.80%)	3 / 66 (4.55%)
Nervous system disorders
Headache
subjects affected / exposed	2 / 28 (7.14%)	0 / 103 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	0	0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	2 / 28 (7.14%)	0 / 103 (0.00%)	0 / 66 (0.00%)
occurrences all number	3	0	0
Malaise
subjects affected / exposed	2 / 28 (7.14%)	0 / 103 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	2 / 28 (7.14%)	0 / 103 (0.00%)	0 / 66 (0.00%)
occurrences all number	2	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	5 / 28 (17.86%)	7 / 103 (6.80%)	3 / 66 (4.55%)
occurrences all number	6	7	3

More information

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Were there any global substantial amendments to the protocol? Yes

01 Jul 2021

The protocol Edition 2.0 has been created to implement and incorporate revisions requested by the Paul Ehrlich Institute on 22-Jun-2021.

15 Oct 2021

The protocol Edition 3.0 has been created to implement the addition of a further treatment group of seropositive subjects (Group 3) receiving a dose of 50μg of IMP as well as adapting sample sizes of Group1 and 2.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None

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Clinical trials

Clinical Trial Results:
An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

Primary: SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

Secondary: Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

Primary: SARS-CoV-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination

Secondary: Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Secondary: Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.