COVID-19
Conditions
Interventions
One booster dose-level of naked AKS-452X (90 µg) will be administered via s.c.
route to 72 subjects who have only received a primary vaccin, divided in 4
cohorts (one cohort per registered vaccin).
Sponsors
Akston Biosciences Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18-85 years (extremes included), males and females. - 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, or vital signs - 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 - All participants must have received a completed (registered) vaccine or booster at least three months before inclusion in this study (i.e. Pfizer [Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S], AstraZeneca [Vaxzevria]). - 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) 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 the dosing visit, in all women.
Exclusion criteria
Exclusion criteria: - 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 at day 0. - 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. Participants will be screened for SARS-Cov-2 with an EUA-approved PCR test at screening, and at day 0. - 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-452X. 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 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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enhanced immune response rate defined as i) at least 80% of all participants demonstrate any increase in IgG titers between Day 0 and Day 28 and ii) the geometric mean ratio of titers from Day 28 to Day 0 should be at least three (3x) times. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation for local and systemic adverse events after injection every pre-defined scheduled follow-up (post intervention). Participants will continue to be followed passively for additional safety events out to 9 months post-intervention. To achieve these objectives, the following will be measured: o Anti-SARS-CoV-2 SP RBD IgG titers at days 0, 28, 56, 91, 182 and 273 post-boostering. o Serum titer inhibition of recombinant ACE2-SP/RBD binding and/or neutralization of live SARS-CoV-2 virus infection of live cells (Plaque Reduction Neutralization Test, PRNT) at days 0, 28, and 182 o T-cell responses measured ex vivo using PBMCs to measure SP/RBD-specific T cell production of IFN-* and Th1/Th2/Th17 related cytokines via ELISpot or other Ag-specific flow cytometric-based assays on days 0, 28, and 182. | — |
Countries
Netherlands
Outcome results
None listed