Vaccination phase I/II study against COVID-19

Phase 1

• Conditions: COVID-19; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005997-82-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-27
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

-Age 18-65 years (extremes included), males and females. This will be expanded to 85 years of age for phase II.
-SARS-CoV-2 serology (an anti-SARS-Cov-2 SP-specific IgG ELISA):
oTests negative for IgG 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
oNote: one retest of vital functions and ECG is allowed within the screening window
-No clinically significant laboratory abnormalities as determined by the investigator
oNote: 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
-For phase I: nNo invitation is received to get a registered vaccine within the first 2 months after the moment of participation in this study. For phase II this criterium will be abandoned as the whole population will have received an invitation to get a registered vaccine. Therefore, a participant should agree not to receive a registered vaccine within 28 days after receiving the last AKS-452 vaccine.
-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:
oAt least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >30 mIU/mL) at screening;
oSurgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
oWill 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
oNote: 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.
oNote: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 176

Exclusion Criteria

- Pregnant of 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 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 SARS-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified