Anti-COVID19 VaccinaTion AKS-452X BOOSTER Study (ACT-BOOSTER study)

Phase 2

Conditions: COVID-19
10047438

Registration Number: NL-OMON51511

Lead Sponsor: Akston Biosciences Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 222

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

- 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.