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

NCT04681092 | Completed Phase 1 DMC

• 1 other identifier: NL2020-005997-82
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Keywords

vaccine; safety; immunogenicity; dose-finding; exploratory efficacy

Outcome Measures

Primary Outcomes (1)

• Safety / Tolerability

  CTCAE-scoring

  35 days

Secondary Outcomes (1)

• Immunogenicity

  180 days

Study Arms (8)

AKS-452 s.c.(A)

EXPERIMENTAL

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

Biological: AKS-452

AKS-452 s.c. (B)

EXPERIMENTAL

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

Biological: AKS-452

AKS-452 s.c. (C)

EXPERIMENTAL

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

Biological: AKS-452

AKS-452 s.c. (D)

EXPERIMENTAL

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

Biological: AKS-452

AKS-452 s.c. (E)

EXPERIMENTAL

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

Biological: AKS-452

AKS-452 s.c. (F)

EXPERIMENTAL

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

Biological: AKS-452

Phase 2, single-dose injection

EXPERIMENTAL

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

Biological: AKS-452

Phase 2, two-dose injection

EXPERIMENTAL

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

Biological: AKS-452

Interventions

AKS-452 BIOLOGICAL

s.c. or i.m. vaccination

AKS-452 s.c. (B); AKS-452 s.c. (C); AKS-452 s.c. (D); AKS-452 s.c. (E); AKS-452 s.c. (F); AKS-452 s.c.(A); Phase 2, single-dose injection; Phase 2, two-dose injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Akston Biosciences Corporation: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (2)

• Feitsma EA, Janssen YF, Boersma HH, van Sleen Y, van Baarle D, Alleva DG, Lancaster TM, Sathiyaseelan T, Murikipudi S, Delpero AR, Scully MM, Ragupathy R, Kotha S, Haworth JR, Shah NJ, Rao V, Nagre S, Ronca SE, Green FM, Aminetzah A, Sollie F, Kruijff S, Brom M, van Dam GM, Zion TC. A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452. Vaccine. 2023 Mar 24;41(13):2184-2197. doi: 10.1016/j.vaccine.2023.02.057. Epub 2023 Feb 23.

  PMID: 36842886 DERIVED

• Janssen YF, Feitsma EA, Boersma HH, Alleva DG, Lancaster TM, Sathiyaseelan T, Murikipudi S, Delpero AR, Scully MM, Ragupathy R, Kotha S, Haworth JR, Shah NJ, Rao V, Nagre S, Ronca SE, Green FM, Aminetzah A, Sollie F, Kruijff S, Brom M, van Dam GM, Zion TC. Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. Vaccine. 2022 Feb 23;40(9):1253-1260. doi: 10.1016/j.vaccine.2022.01.043. Epub 2022 Jan 31.

  PMID: 35115195 DERIVED

Related Links

• Scientific manuscript phase I clinical study AKS-452

MeSH Terms

Conditions

COVID-19

Interventions

AKS-452 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Schelto Kruijff, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, open-label, combinatorial safety, tolerability and exploratory efficacy

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 23, 2020
• Study Start: April 6, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)