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First-in-human Trial of the Coronavirus Virus-like Particle Subunit Vaccine ABNCoV2 in SARS-CoV-2-naïve Adult Volunteers in Good Health

Trial Profile

First-in-human Trial of the Coronavirus Virus-like Particle Subunit Vaccine ABNCoV2 in SARS-CoV-2-naïve Adult Volunteers in Good Health

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 May 2021

At a glance

  • Drugs ABNCoV2 cVLP based COVID 2019 vaccine AdaptVac (Primary) ; MF 59
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Acronyms COUGH-1
  • Most Recent Events

    • 27 May 2021 According to a Bavarian Nordic media release, results are expected in the third quarter of 2021.
    • 09 Mar 2021 According to a Bavarian Nordic media release, results are expected by the end of June 2021.
    • 08 Mar 2021 According to an AdaptVac media release, the Clinical trial application (CTA) has been approved by the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands ,first human dosing in this trial is planned for March 12, 2021, CTA approval is in line with plan to present initial data of this study in Q1 2021

Trial Overview

Purpose

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.

Primary Endpoints

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

description: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE)
time_frame: up to 28 weeks

Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies

description: Concentration of ABNCoV2-specific antibodies
time_frame: 14 days following first vaccination.

Other Endpoints

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

description: Number and severity of at least possibly related solicited AEs
time_frame: within one week following administration of ABNCoV2.

Concentration of ABNCoV2-specific antibodies at baseline and during immunization and follow up.

description: 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.

description: 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.

description: 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)

description: 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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 42

  • Sex male & female
  • Age Group 18-55 years; adult

Patient Inclusion Criteria

1. Subject must sign written informed consent to participate in the trial. 2. 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. 3. In the opinion of the investigator, the subject can and will comply with the requirements of the protocol. 4. 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). 5. 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. 6. 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). 7. The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines. 8. 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04839146 ClinicalTrials.gov: US National Institutes of Health
NL76192-000-20 -

Organisations

  • Affiliations AdaptVac; AGC Biologics; Bavarian Nordic

Trial Dates

  • Initiation Dates

    Actual : 11 Mar 2021

  • Primary Completion Dates

    Planned : 20 Dec 2021

  • End Dates

    Planned : 20 Dec 2021

Other Details

  • Design open; parallel; prospective; sequential
  • Phase of Trial Phase I/II
  • Location Netherlands
  • Focus Adverse reactions; First in man; Pharmacodynamics

Interventions

Drugs Route Formulation
ABNCoV2 cVLP based COVID 2019 vaccine AdaptVacPrimary Drug Intramuscular Injection
MF 59 Intramuscular Injection

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

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 (SARS-CoV-2 vaccine) Other Name: cVLP-RBD, RBDn-CLP, ABNCoV2

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Benjamin Mordmüller, Prof Stichting Radboud university medical center
-
Merel J. Smit, MD
024-3619515 +31
merel.smit@radboudumc.nl
024-3619515 Ext: +31
show details
Radboud univserity medical center Netherlands

Centres

Centre Name Location Trial Centre Country
European Union
-
-
Radboud univserity medical center Nijmegen, Gelderland Netherlands
Radhoud University Medical Centre
-
Netherlands
Stichting Radboud university medical center
-
-

Trial History

Event Date Event Type Comment
27 May 2021 Other trial event According to a Bavarian Nordic media release, results are expected in the third quarter of 2021. Updated 02 Jun 2021
22 Apr 2021 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 22 Apr 2021
13 Apr 2021 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04839146) Updated 13 Apr 2021
09 Mar 2021 Other trial event According to a Bavarian Nordic media release, results are expected by the end of June 2021. Updated 16 Mar 2021
08 Mar 2021 Other trial event According to an AdaptVac media release, the Clinical trial application (CTA) has been approved by the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands ,first human dosing in this trial is planned for March 12, 2021, CTA approval is in line with plan to present initial data of this study in Q1 2021 Updated 15 Mar 2021
08 Mar 2021 Status change - recruiting Status changed from planning to recruiting according to an AdaptVac media release Updated 15 Mar 2021
08 Mar 2021 Other trial event According to a Bavarian Nordic media release, this trial is projected to start shortly. Updated 12 Mar 2021
12 Jan 2021 Other trial event According to an Attana media release, the Clinical trial application (CTA) was submitted to the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands last week and is expected to be approved under a COVID-19 fast-track review progress. Preliminary results before end of Q1 2021. Updated 18 Jan 2021
12 Jan 2021 Other trial event According to a Bavarian Nordic media release, the company is on track for delivery of initial PhI/IIa results in Q1 2021 Updated 18 Jan 2021
22 Jul 2020 Other trial event According to a Bavarian Nordic media release, the company expects to initiate this study during the fourth quarter of 2020, with data expected to become available early in 2021. Updated 24 Jul 2020
06 May 2020 Other trial event According to a Bavarian Nordic media release, company enters agreement with AdaptVac to advance COVID-19 vaccine program. The parties seek to enter into the final license agreement within the next two months.Current plan is to initiate a clinical study later this year. Updated 11 May 2020
24 Apr 2020 Other trial event According to an AdaptVac media release, the company announced signing of agreement with AGC Biologics for manufacture and scale-up of the COVID-19 (SARS-CoV-2) Coronavirus vaccine and this partnership has the potential to advance the initiation of this trial to the end of 2020. Updated 27 Apr 2020
13 Mar 2020 New trial record New trial record Updated 13 Mar 2020
09 Mar 2020 Other trial event According to an AdaptVac media release, PREVENT-nCoV consortium announces awarding of EU Horizon 2020 grant amounts of 2,7 MEUR to develop and test theCOVID-19 (SARS-CoV-2) Coronavirus vaccine in this trial. Updated 13 Mar 2020
09 Mar 2020 Other trial event According to an AdaptVac media release, the company plans to initiate this trial within 12 months. Updated 13 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. Bavarian Nordic. Bavarian Nordic Enters Agreement with AdaptVac to Advance COVID-19 Vaccine Program. Media-Rel 2020;.

    Media Release
  3. Bavarian Nordic. Bavarian Nordic and AdaptVac Sign Final License Agreement on COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  4. AdaptVac. PREVENT-nCoV consortium announces EU grant award for COVID-19 vaccine development programme. Media-Rel 2020;.

    Media Release
  5. Attana. Significant progress made in new COVID-19 vaccine developed by the team of Prof Salanti. Media-Rel 2021;.

    Media Release
  6. Bavarian Nordic. Bavarian Nordic A/S Seeks to Strengthen its Capital Base and Commits to Ambitious Strategy on Promising COVID-19 Vaccine Candidate. Media-Rel 2021;.

    Media Release
  7. Bavarian Nordic. Bavarian Nordic Reports Encouraging Preclinical Data for COVID-19 Vaccine Candidate Ahead of First-in-Human Trial. Media-Rel 2021;.

    Media Release
  8. AdaptVac. Manufacturing agreement with AGC Biologics accelerates COVID-19 vaccine program. Media-Rel 2020;.

    Media Release
  9. AdaptVac. Strong preclinical immunization data for the ABNCoV2 cVLPbased COVID-19 vaccine published in Nature Communications. Media-Rel 2021;.

    Media Release
  10. AdaptVac. Approval and initiation of the COVID-19 clinical phase I/II study for the ABNCoV2 vaccine. Media-Rel 2021;.

    Media Release
  11. Bavarian Nordic. Bavarian Nordic Announces Interim Results for the First Three Months of 2021. Media-Rel 2021;.

    Media Release
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