Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study (ACT-Study)
- Conditions
- COVID-1910047438
- Registration Number
- NL-OMON51213
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
- Age 18-85 years (extremes included), males and females
- SARS-CoV-2 serology (an anti-SARS-Cov-2 SP-specific IgG ELISA):
o Tests negative for IgG titer and no known prior SARS-Cov-2 infection
- Body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive
- General good health, without significant medical illness, as determined via
physical exam findings, ECG or vital signs
o Note: one retest of vital functions and ECG is allowed within the screening
window
- No clinically significant laboratory abnormalities as determined by the
investigator
o Note: one retest of lab tests is allowed within the screening window
- Informed Consent Form signed voluntarily before any study-related procedure
is performed, indicating that the subject understands the purpose and
procedures required for the study and is willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in this
protocol
- For phase I: No invitation is received to get a registered vaccine
within the first 2 months after the moment of participation in this study.
For phase II this criterium will be abandoned as the whole population
will have received an invitation to get a registered vaccine. Therefore, a
participant should agree not to receive a registered vaccine within 28
days after receiving the last AKS-452 vaccine. For the booster study with
the naked AKS-452 (non-adjuvanted), the participants should waive
their right to receive a registered vaccine within the first 56 days after
receiving the booster vaccine.
- Negative hepatitis panel (including hepatitis B surface Ag and anti-hepatitis
C virus Abs) and negative human immunodeficiency virus Ab and Ag screens at
screening
- Female subjects should fulfil one of the following criteria:
o At least 1 year post-menopausal (amenorrhea >12 months and/or
follicle-stimulating hormone >30 mIU/mL) at screening;
o Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
o Will use adequate forms of contraceptives from screening to discharge.
- Female subjects of childbearing potential and male subjects who are sexually
active with a female partner of childbearing potential must agree to the use of
an effective method of birth control from screening to discharge
o Note: medically acceptable methods of contraception that may be used by the
subject and/or partner include combined oral contraceptive, contraceptive
vaginal ring, contraceptive injection, intrauterine device, etonogestrel
implant, double barrier, sterilization and vasectomy
- Female subject has a negative pregnancy test at screening and upon check-in
at the clinical site.
o Note: pregnancy testing will consist of a serum pregnancy test at screening
and urine pregnancy tests at other (dosing) visits, in all women.
- Pregnant or breast feeding females
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,
hematologic, rheumatologic, endocrine, autoimmune, or renal disease
- Any laboratory test which is abnormal, and which is deemed by the
Investigator(s) to be clinically significant
- Behavioral or cognitive impairment or psychiatric disease that in the opinion
of the investigator affects the ability of the subject to understand and
cooperate with the study protocol
- Current alcohol/illicit drug/nicotine abuse or addiction: history or evidence
of current drug use or addiction (positive drug screen for amphetamines,
barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or signs of
excessive use of alcohol at screening and Day -2.
- Presence of any febrile illness (T > = 38.0°C or lab confirmed viral disease
(PCR)) or symptoms suggestive of a viral respiratory infection within 1 weeks
prior to vaccination
- Use of corticosteroids (excluding topical preparations for cutaneous or nasal
use) or use of immunosuppressive drugs within 30 days before inoculation
- A history of anaphylaxis, history of allergic reaction to vaccine, known
allergy to one of the components in AKS-452. Mild allergies without angio-edema
or treatment need can be included if deemed not to be of clinical significance
(including but not limited to allergy to animals or mild seasonal hay fever)
- A history of asthma within the past 10 years, or a current diagnosis of
asthma or reactive airway disease associated with exercise
- Receipt of a licensed vaccine within 4 weeks prior to viral inoculation
- Received any (experimental) SARS-CoV-2 vaccine or drug
- Receipt of blood or blood-derived products (including immunoglobulin) within
6 months prior to vaccination.
- Receipt of another investigational agent within 30 days or 5 times the
product half-life (whichever is longest) prior to vaccination
- Shares household with/works with immunocompromised individual(s), adults with
significant cardiopulmonary disease, persons with significant asthma,
institutionalized elderly or elderly with functional disability
- Deprived of freedom by an administrative or court order or in an emergency
setting
- Any condition that in the opinion of the principal investigator (PI) would
jeopardize the safety or rights of a person participating in the trial or would
render the person unable to comply with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I: safety / immunogenicity<br /><br>Phase II: safety / immunogenicity and initial efficacy as expressed by<br /><br>neutralizing IgG titers / seroconversion.</p><br>
- Secondary Outcome Measures
Name Time Method