Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Covid19

Treatments: Biological: AKS-452

Study type: Interventional

Funder types: Other

Identifiers

NCT04681092

NL2020-005997-82

Details and patient eligibility

About

Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study

Full description

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 8 patient groups

AKS-452 s.c.(A)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose

Treatment:

Biological: AKS-452

AKS-452 s.c. (B)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL), two-dose

Treatment:

Biological: AKS-452

AKS-452 s.c. (C)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (45 ug, 205 uL), single-dose

Treatment:

Biological: AKS-452

AKS-452 s.c. (D)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (45 ug, 250 uL), two-dose

Treatment:

Biological: AKS-452

AKS-452 s.c. (E)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (90 ug, 500 uL), single-dose

Treatment:

Biological: AKS-452

AKS-452 s.c. (F)

Experimental group

Description:

Subcutaneous injection of pre-defined dose (90 ug, 500 uL), two-dose

Treatment:

Biological: AKS-452

Phase 2, single-dose injection

Experimental group

Description:

Subcutaneous injection of selected dose based on phase 1 data, dose (90 ug, 500 uL)

Treatment:

Biological: AKS-452

Phase 2, two-dose injection

Experimental group

Description:

Subcutaneous injection of selected dose based on phase 1 data, dose (45 ug, 500 uL) twice.

Treatment:

Biological: AKS-452