anti-covid19 aks-452 fusion protein vaccine - act study

Conditions: Covid19

Summary: combinatorial phase i/ii safety, tolerability and immunogenicity single center open-label clinical study of aks-452 covid-19 vaccination study

the study is designed as a combinatorial single-center open-label phase i and ii clinical study design: i. a phase i dose-finding and safety / tolerability study combined with, ii. a phase ii safety / efficacy study on the biological activity of aks-452 against covid-19. to warrant more extensive development towards a phase iii clinical study. the study will have a duration of approximately 4 months and will be executed at the university medical center groningen, the netherlands supported by the subsidizing party akston biosciences.

Eligibility criteria:
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. exclusion criteria: 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.

Keywords: vaccine safety immunogenicity dose-finding exploratory efficacy