COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04681092

Gooitzen M van Dam

g.m.van.dam@umcg.nl

2020-12-23

Completed

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

inclusion criteria: sars-cov-2 serology by akston (a quantitative anti-sars-cov-2 sp/rbd-specific igg elisa): - undetectable or < 5 μg/ml 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 - note: one retest of vital functions and ecg is allowed within the screening window - no clinically significant laboratory abnormalities as determined by the investigator - 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 - non-smoker (including prior smokers having stopped smoking for more than 3 months at time of screening) or non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during confinement. - negative alcohol breath test and urine drug screen at screening and upon check-in at the clinical site. - 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: - at least 1 year post-menopausal (amenorrhea >12 months and/or follicle stimulating hormone >30 miu/ml) at screening; - surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation); - 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 - 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. - note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.

a potential subject who meets any of the following criteria will be excluded from participation in this study: - pregnant of breastfeeding 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 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-oedema 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 sara-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.

8

University Medical Center Groningen

18

65

Netherlands

Healthy volunteers

N/A

112

Safety / Tolerability

None

Phase 1/Phase 2

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