Clinical Trial Protocol section 2.The main objectives of the trial are 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…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Health condition
COVID-19
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical Trial Protocol section 10.1
- Number of at least possibly related Grade 3 adverse events (AE) and serious
adverse events (SAE) from time of first administration of ABNCoV2 to the end of
the follow-up period.
- Concentration of ABNCoV2-specific antibodies 14 days following first
vaccination.
Secondary outcome
Clinical Trial Protocol section 10.2
- Number and severity of at least possibly related solicited AEs within one
week following administration of ABNCoV2 (day 0 to 7).
Exploratory study endpoints (Clinical Trial Protocol section 10.3):
- Concentration of ABNCoV2-specific antibodies at baseline and during
immunization and follow up.
- Inhibitory titre in invasion inhibition assay at baseline and during
immunization and follow up.
- Cellular immune responses (T and B cell) at baseline and during immunization
and follow up.
Background summary
Clinical Trial Protocol section 1.1
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a zoonotic
virus, primarily causing respiratory symptoms in humans, ranging from very mild
to life threatening. The current outbreak of SARS-CoV-2 was first reported in
late 2019 and has spread rapidly around the world, leading the World Health
Organization (WHO) to declare a pandemic. A vaccine could complement
non-pharmaceutical interventions (NPC), in order to protect vulnerable
populations by reducing virus-spread, decrease the load on health care systems
and reduce the economic impact of NPC. The ABNCoV2 vaccine is intended to
protect against coronavirus disease 2019 (COVID-19) and limit spread of
SARS-CoV-2.
Study objective
Clinical Trial Protocol section 2.
The main objectives of the trial are 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.
Study design
Clinical Trial Protocol section 3.
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,
SARS-CoV-2-naïve volunteers. The trial will be carried out by the Radboud
University Medical Center (Radboudumc).
Seven groups of volunteers (n=6) will receive a given dose of ABNCoV2, either
with or without the adjuvant 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 *g 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
until superiority or futility of the MF59-adjuvanted against the non-adjuvanted
formulation is shown. Follow-up visites will take place at the following
timepoints: day 1, 7, 14, 25, 29, 35, 42, 70, 119 and 196 after the first
ABN-CoV2 administration. Follow-up visits by telephone will occur 2 days after
the ABN-CoV2 vaccine and booster administration. All subjects will be followed
for approcimately 196 days (28 weeks) after the first ABN-CoV2 vaccine
administration.
Intervention
Clinical Trial Protocol section 5.
Volunteers will sequentially receive an administration of non-adjuvanted or
MF59-adjuvanted ABNCoV2 vaccination. All subjects will receive a booster with
the same dose and formulation 4 weeks following the first vaccination.
Study burden and risks
There is no direct benefit from participation in this trial. Information about
their own general health status may be a potential indirect benefit for
participants. It will be made clear that the vaccine is experimental and may
not protect against COVID-19. Participating in this trial includes risks
associated with intramuscular ABNCoV2 administration, immune-response against
the vaccine and blood sampling. Volunteers will experience frequent follow-up
visits, physical examinations, screening for HIV, hepatitis B and hepatitis C,
drug screening, a pregnancy test (for females) and COVID-19 diagnostics. They
are expected to fill out a memory aid/diary, measure their temperature during
one week following ABNCoV2 administrations and abiding to all the study rules.
Geert Grooteplein Zuid 28
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 28
Nijmegen 6525 GA
NL
Listed location countries
Age
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 contraception
for the duration of the study. Female subjects must have a negative pregnancy
test at the inclusion visit.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-004621-22-NL |
| CCMO | NL76192.000.20 |
| OMON | NL-OMON20987 |