CompletedNCT04839146COUGH-1Updated Feb 17, 2026Results posted

Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)

A Phase 1 interventional study of ABNCoV2 Vaccine in Covid19, Severe Acute Respiratory Syndrome and SARS-CoV-2 Infection, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Radboud University Medical Center · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 45
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2.

Read the detailed description

This first-in-human phase 1 trial of ABNCoV2 is a single center, sequential dose-escalation, open labelled trial to establish the safety and tolerability of two doses of ABNCoV2, formulated with and without MF59 in healthy, adult, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-naïve volunteers. The immunological objective of this trial is to identify a dosage that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2. The trial will be carried out by the Radboud University Medical Center (Radboudumc).

The trial involves first-in-human administration, dose escalation of ABNCoV2 and adjuvant selection. Volunteers will be screened for eligibility and receive two vaccinations by intramuscular injection. While we cannot predict with certainty the safety in human subjects, we have adopted a safety-orientated staggered trial design with ascending doses of ABNCoV2. Seven groups of volunteers (n=6) will receive a given dose of ABNCoV2, either with or without MF59, followed by a booster with the same dose and formulation four weeks after the first vaccination. All vaccinations will be given as intramuscular injection. The pre-defined escalation schedule will start with 6 μg ABNCoV2, with a maximum dose of 70 μg. Dose-escalation will proceed only in absence of protocol-defined safety signals. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel at the first three escalation steps (Group 1-3) to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation. Up to forty-two (n=42) subjects will be enrolled, as well as one reserve subject per group.

Safety follow-up will be done at following timepoints: baseline, day 1, day 2, day 7, day 14, day 25, day 29, day 30, day 35, day 42, day 70, day 119 and day 196 after first ABNCoV2 administration.

Conditions studied

Covid19
Severe Acute Respiratory Syndrome
SARS-CoV-2 Infection

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 45 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject must sign written informed consent to participate in the trial.
Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of the study by passing a quiz (assessment of understanding). Subjects must score at least 80% correct on a multiple-choice quiz. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them, and they will have the opportunity to retest.
In the opinion of the investigator, the subject can and will comply with the requirements of the protocol.
Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until 24 weeks following last vaccination (end of study).
Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health at time of ABNCoV2 administration.
Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s).
The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines.
Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All other female subjects must agree to use continuous adequate contraception2 for the duration of the study. Female subjects must have a negative pregnancy test at the inclusion visit.

Exclusion criteria

Exclusion Criteria:

Any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the US Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials [30].

2. History of COVID-19 infection. 3. Chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.

4. Positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion.

5. Screening tests positive for SARS-CoV-2, SARS-CoV-2 antibodies, Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).

6. Receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period.

7. Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.

8. Immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed SARS-CoV-2 vaccine, given within the framework of the national SARS-CoV-2 vaccination campaign. The time between last vaccination with ABNCoV2 and a SARS-CoV-2 vaccine provided by the campaign shall be at least 4 weeks.

9. Known hypersensitivity to any of the vaccine components (adjuvant or protein).

10. Administration of immunoglobulins and/or any blood products within the three months prior to the first dose of ABNCoV2 or planned administration during the study period.

11. Previous participation in a COVID-19 vaccine study. 12. Body Mass Index (BMI) >35 kg/m2. 13. Pregnancy, lactation or intention to become pregnant during the study period.

14. History of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment.

15. Being an employee or student of the department of Medical Microbiology of the Radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only.

16. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 45 participants (actual)

Study arms

Experimental
Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3) will receive the non-adjuvanted vaccine formulation and the other half (n=3) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted or MF59-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant
The subjects in Group 6 (n=6) will receive the next lower dosage of the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine
Experimental
Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant
The subjects in Group 7 (n=6) will receive the highest non-adjuvanted or MF59-adjuvanted ABNCoV2 dose achieved intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
Biological: ABNCoV2 Vaccine

Interventions

BiologicalABNCoV2 Vaccine
SARS-CoV-2 vaccine
Also known as: cVLP-RBD, RBDn-CLP, ABNCoV2

What researchers measure

Primary outcomes

Number of at Least Possibly Related Grade 3 Adverse Events (AE) and Serious Adverse Events (SAE)
Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE)
Time frame: up to 28 weeks
Concentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination
Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies 14 days following first vaccination
Time frame: 14 days following first vaccination.

Secondary outcomes

Number of Participants With at Least Possibly Related Solicited AEs
Secondary study endpoint: Number and severity of at least possibly related solicited AEs
Time frame: one week after each vaccination with of ABNCoV2.

Other outcomes

Concentration of ABNCoV2-specific Antibodies at Baseline and During Immunization and Follow up.
ABNCoV2-specific antibody concentrations will be measured by ELISA during immunisation and follow-up.
Time frame: up to 28 weeks
Inhibitory Titre in Invasion Inhibition Assay at Baseline and During Immunization and Follow up.
Inhibitory titre in invasion inhibition assay at baseline and during immunization and follow up. Inhibitory titres will be measured in an in vitro SARS-CoV-2 invasion inhibition assay.
Time frame: up to 28 weeks
Cellular Immune Responses (T and B Cell) at Baseline and During Immunization and Follow up.
Cellular responses will be analysed by cytometry and enzyme-linked absorbent spot (ELISpot) assay.
Time frame: up to 28 weeks
Correlation of Response Vaccine to Habitual Sleep Using the Pittsburgh Sleep Quality Index (PSQI)
The PSQI will be used to investigate if sleep quality is associated with immune responses to the vaccine.
Time frame: one month prior first ABNCoV2 immunization

Results

Posted Feb 12, 2024

Participant flow

Participant flow — Overall Study
Milestone	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Started	3	3	3	3	3	3	6	6	9	6
Completed	3	3	3	3	3	3	6	6	9	6
Not completed	0	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryNumber of at Least Possibly Related Grade 3 Adverse Events (AE) and Serious Adverse Events (SAE)

Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE)

Time frame:: up to 28 weeks
Reported as:: Number · adverse events

Number of at Least Possibly Related Grade 3 Adverse Events (AE) and Serious Adverse Events (SAE)
adverse events	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Number of at Least Possibly Related Grade 3 Adverse Events (AE) and Serious Adverse Events (SAE)	0	1	0	0	0	0	0	1	0	0

PrimaryConcentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination

Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies 14 days following first vaccination

Time frame:: 14 days following first vaccination.
Reported as:: Median · ug/mL

Concentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination
ug/mL	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Concentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination	2.2 (0.4 to 5.8)	4.9 (3.6 to 30.1)	7.1 (2.3 to 7.1)	9.4 (8.7 to 95.5)	2.3 (1.6 to 34.4)	0.4 (0.4 to 5.7)	4.2 (2.4 to 22.0)	4.9 (0.1 to 16.8)	5.0 (1.7 to 20.4)	7.3 (5.5 to 35.1)

SecondaryNumber of Participants With at Least Possibly Related Solicited AEs

Secondary study endpoint: Number and severity of at least possibly related solicited AEs

Time frame:: one week after each vaccination with of ABNCoV2.
Reported as:: Count of participants · Participants

Number of Participants With at Least Possibly Related Solicited AEs
Participants	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Number of Participants With at Least Possibly Related Solicited AEs	2	3	3	3	3	2	5	6	8	5

Other pre-specifiedConcentration of ABNCoV2-specific Antibodies at Baseline and During Immunization and Follow up.

ABNCoV2-specific antibody concentrations will be measured by ELISA during immunisation and follow-up.

Time frame:: up to 28 weeks

Results for this outcome have not been posted.

Other pre-specifiedInhibitory Titre in Invasion Inhibition Assay at Baseline and During Immunization and Follow up.

Inhibitory titre in invasion inhibition assay at baseline and during immunization and follow up. Inhibitory titres will be measured in an in vitro SARS-CoV-2 invasion inhibition assay.

Time frame:: up to 28 weeks

Results for this outcome have not been posted.

Other pre-specifiedCellular Immune Responses (T and B Cell) at Baseline and During Immunization and Follow up.

Cellular responses will be analysed by cytometry and enzyme-linked absorbent spot (ELISpot) assay.

Time frame:: up to 28 weeks

Results for this outcome have not been posted.

Other pre-specifiedCorrelation of Response Vaccine to Habitual Sleep Using the Pittsburgh Sleep Quality Index (PSQI)

The PSQI will be used to investigate if sleep quality is associated with immune responses to the vaccine.

Time frame:: one month prior first ABNCoV2 immunization

Results for this outcome have not been posted.

Adverse events

Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	0/3 (0%)	0/3 (0%)	3/3 (100%)
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	0/3 (0%)	1/3 (33.3%)	3/3 (100%)
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	0/3 (0%)	0/3 (0%)	3/3 (100%)
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	0/3 (0%)	0/3 (0%)	3/3 (100%)
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	0/3 (0%)	0/3 (0%)	3/3 (100%)
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	0/3 (0%)	0/3 (0%)	3/3 (100%)
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	0/6 (0%)	0/6 (0%)	6/6 (100%)
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	0/6 (0%)	0/6 (0%)	6/6 (100%)
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	0/9 (0%)	0/9 (0%)	9/9 (100%)
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	0/6 (0%)	1/6 (16.7%)	6/6 (100%)

Most frequent serious events

Most frequent serious events
Event	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Superficial basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/3	1/3	0/3	0/3	0/3	0/3	0/6	0/6	0/9	0/6
Ligament ruptureMusculoskeletal and connective tissue disorders	0/3	0/3	0/3	0/3	0/3	0/3	0/6	0/6	0/9	1/6

Most frequent other events

Most frequent other events
Event	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
TendernessSkin and subcutaneous tissue disorders	0/3	3/3	3/3	2/3	1/3	3/3	5/6	3/6	8/9	3/6
PainSkin and subcutaneous tissue disorders	2/3	3/3	3/3	3/3	3/3	3/3	5/6	6/6	9/9	6/6
FatigueGeneral disorders	1/3	2/3	2/3	3/3	0/3	2/3	4/6	3/6	6/9	4/6
HeadacheGeneral disorders	1/3	3/3	2/3	2/3	3/3	2/3	4/6	2/6	6/9	3/6
DrowsinessGeneral disorders	0/3	0/3	0/3	0/3	0/3	1/3	1/6	2/6	2/9	4/6
IndurationSkin and subcutaneous tissue disorders	1/3	1/3	0/3	1/3	1/3	1/3	2/6	2/6	4/9	3/6
ErythemaSkin and subcutaneous tissue disorders	0/3	0/3	0/3	0/3	0/3	0/3	2/6	3/6	2/9	3/6
ChillsGeneral disorders	0/3	1/3	0/3	0/3	1/3	0/3	3/6	1/6	1/9	2/6
FeverGeneral disorders	0/3	0/3	0/3	0/3	0/3	0/3	1/6	2/6	0/9	1/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Total
Median	31 (21 to 35)	27 (22 to 52)	25 (23 to 34)	37 (22 to 37)	27 (22 to 28)	48 (33 to 54)	25.5 (20 to 44)	20.5 (20 to 46)	24 (21 to 45)	24 (18 to 29)	26 (18 to 54)

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Total
Female	2	3	2	1	2	2	4	3	4	3	26
Male	1	0	1	2	1	1	2	3	5	3	19

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Total
Count of participants	—	—	—	—	—	—	—	—	—	—	0

Bodyweight (kg)
Bodyweight (kg)(kg)	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Total
Median	79 (61 to 96)	66 (59 to 69.6)	78 (76 to 89.4)	88 (62 to 94)	70.1 (61.2 to 79)	81 (72.8 to 91)	75 (60 to 97)	77.5 (66 to 90)	76.6 (61 to 91)	69.5 (60 to 88)	76 (59 to 97)

BMI (kg/m^2)
BMI (kg/m^2)(kg/m^2)	Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant	Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant	Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant	Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant	Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant	Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant	Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant	Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant	Total
Median	23 (22.1 to 31.0)	22.4 (18.4 to 24.4)	26.0 (24.9 to 32.1)	24.9 (22.8 to 28.4)	23.6 (20.5 to 25.4)	26.4 (24.9 to 26.9)	25.0 (17.5 to 27.3)	23.7 (20.5 to 26.6)	23.3 (20.4 to 29.9)	24.5 (20.5 to 27.1)	24.2 (17.5 to 32.1)

Study locations

1 site

Radboud univserity medical center
Nijmegen, Gelderland 6525GA, Netherlands

References and documents

Publications

Smit MJ, Sander AF, Ariaans MBPA, Fougeroux C, Heinzel C, Fendel R, Esen M, Kremsner PG, Ter Heine R, Wertheim HF, Idorn M, Paludan SR, Underwood AP, Binderup A, Ramirez S, Bukh J, Soegaard M, Erdogan SM, Gustavsson T, Clemmensen S, Theander TG, Salanti A, Hamborg M, de Jongh WA, McCall MBB, Nielsen MA, Mordmuller BG; COUGH-1 trial study group. 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. Lancet Microbe. 2023 Mar;4(3):e140-e148. doi: 10.1016/S2666-5247(22)00337-8. Epub 2023 Jan 18. PubMed 36681093 ↗

Study documents

Study protocol · Mar 31, 2021
Statistical analysis plan · Apr 25, 2021

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04839146
Lead sponsor: Radboud University Medical Center
Collaborators: European Union
Responsible party: Sponsor
First posted: Apr 9, 2021
Start date: Mar 11, 2021
Primary completion: Dec 30, 2021
Completion: Feb 25, 2022
Results posted: Feb 12, 2024
Last update: Feb 17, 2026

Study contacts

Benjamin Mordmüller, Prof

principal investigator · Stichting Radboud university medical center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)

Study summary

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Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria