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| Name | Class |
|---|---|
| European Union | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 6 microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
| Group 2: 12 microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
| Group 3: 25 microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
| Group 4: 50 microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABNCoV2 Vaccine | Biological | SARS-CoV-2 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 14 days following first vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least Possibly Related Solicited AEs | Secondary study endpoint: Number and severity of at least possibly related solicited AEs | one week after each vaccination with of ABNCoV2. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 28 weeks |
| Inhibitory Titre in Invasion Inhibition Assay at Baseline and During Immunization and Follow up. |
Inclusion 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.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Mordmüller, Prof | Stichting Radboud university medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud univserity medical center | Nijmegen | Gelderland | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36681093 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 1A (n=3), subjects will receive the non-adjuvanted vaccine 6 μg ABNCoV2 formulation intramuscularly. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG001 | Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant | In Group 1B (n=3), subjects will receive the MF59-adjuvanted vaccine 6 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG002 | Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 2A (n=3), subjects will receive the non-adjuvanted vaccine 12 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG003 | Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant | In Group 2B (n=3), subjects will receive the MF59-adjuvanted vaccine 12 μg ABNCoV2 formulation intramuscularly. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG004 | Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 3A (n=3), subjects will receive the non-adjuvanted vaccine 25 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG005 | Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant | In Group 3B (n=3), subjects will receive the MF59-adjuvanted vaccine 25 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG006 | Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG007 | Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG008 | Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| FG009 | Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | adverse events | up to 28 weeks |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Tenderness at injection site (solicited local adverse event) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Mordmüller (Principal investigator) | Radboudumc | +31 (0)24 3619499 | benjamin.mordmueller@radboudumc.nl |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2021 | Jun 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2021 | Jun 6, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000720496 | ABNCoV2 vaccine |
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ABNCoV2 is a virus-like particle vaccine. It will be administered as two intramuscular injections in groups of up to 9 volunteers. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. The pre-defined escalation schedule will start with 6 μg ABNCoV2, followed by 12, 25 and 50 μg with a maximum dose of 70 μg. MF59-adjuvanted and non-adjuvanted formulations will be tested in parallel to detect superiority or futility of the MF59-adjuvanted against the non-adjuvanted formulation at the 6, 12 and 25 μg dosage. Approval for further dose escalation and choice of adjuvant use will be provided by a safety monitoring committee (SMC), supported by pre-defined analyses of safety, tolerability and immunogenicity data at day 14 post-first-vaccination. Recruitment for the two best (safe, tolerable and most immunogenic) regimens will continue until 12 volunteers per regimen have been immunized.
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|
| Group 5: 70 microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
| Group 6: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
| Group 7: t.b.d. microgram ABNCoV2 with/without MF59 adjuvant | Experimental | 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. |
|
|
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. |
| 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. | 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. | one month prior first ABNCoV2 immunization |
| BG001 | Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant | In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG002 | Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG003 | Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG004 | Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG005 | Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG006 | Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG007 | Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG008 | Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG009 | Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Bodyweight (kg) | Median | Full Range | kg |
|
| BMI (kg/m^2) | Median | Full Range | kg/m^2 |
|
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG002 | Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG003 | Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG004 | Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG005 | Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG006 | Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG007 | Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG008 | Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
| OG009 | Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine |
|
|
| Primary | Concentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination | Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies 14 days following first vaccination | Posted | Median | Full Range | ug/mL | 14 days following first vaccination. |
|
|
|
| Secondary | Number of Participants With at Least Possibly Related Solicited AEs | Secondary study endpoint: Number and severity of at least possibly related solicited AEs | Proportion of participants with related adverse event | Posted | Count of Participants | Participants | one week after each vaccination with of ABNCoV2. |
|
|
|
| Other Pre-specified | 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. | Not Posted | up to 28 weeks | Participants |
| Other Pre-specified | 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. | Not Posted | up to 28 weeks | Participants |
| Other Pre-specified | 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. | Not Posted | up to 28 weeks | Participants |
| Other Pre-specified | 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. | Not Posted | one month prior first ABNCoV2 immunization | Participants |
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant | In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant | In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant | In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) 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. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant | In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 9 | 0 | 9 | 9 | 9 |
| EG009 | Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant | The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination. ABNCoV2 Vaccine: SARS-CoV-2 vaccine | 0 | 6 | 1 | 6 | 6 | 6 |
| Ligament rupture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | Traumatic ligament rupture requiring hospitalisation |
|
|
| Pain | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Pain at injection site (solicited local adverse event) |
|
| Induration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Induration at injection site (solicited local adverse event) |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Erythema at injection site (solicited local adverse event) |
|
| Chills | General disorders | MedDRA | Systematic Assessment | Chills (solicited systemic adverse event) |
|
| Drowsiness | General disorders | MedDRA | Systematic Assessment | Drowsiness (solicited systemic adverse event) |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | Fatigue (solicited systemic adverse event) |
|
| Fever | General disorders | MedDRA | Systematic Assessment | Fever (solicited systemic adverse event) |
|
| Headache | General disorders | MedDRA | Systematic Assessment | Headache (solicited systemic adverse event) |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Male |
|