First-in-human trial of the Coronavirus virus-like particle subunit vaccine ABNCoV2 in SARS-CoV-2-naïve adult volunteers in good health (COUGH-1)
- Conditions
- COVID-191004743810024970coronavirus
- Registration Number
- NL-OMON50898
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
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 contraception
for the duration of the study. Female subjects must have a negative pregnancy
test at the inclusion visit.
1. Any clinically significant abnormal finding on clinical examination or
laboratory screening tests according to the FDA Toxicity Grading Scale for
Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical
Trials.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical Trial Protocol section 10.1<br /><br>- Number of at least possibly related Grade 3 adverse events (AE) and serious<br /><br>adverse events (SAE) from time of first administration of ABNCoV2 to the end of<br /><br>the follow-up period.<br /><br>- Concentration of ABNCoV2-specific antibodies 14 days following first<br /><br>vaccination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical Trial Protocol section 10.2<br /><br>- Number and severity of at least possibly related solicited AEs within one<br /><br>week following administration of ABNCoV2 (day 0 to 7).<br /><br><br /><br>Exploratory study endpoints (Clinical Trial Protocol section 10.3):<br /><br>- Concentration of ABNCoV2-specific antibodies at baseline and during<br /><br>immunization and follow up.<br /><br>- Inhibitory titre in invasion inhibition assay at baseline and during<br /><br>immunization and follow up.<br /><br>- Cellular immune responses (T and B cell) at baseline and during immunization<br /><br>and follow up.</p><br>