Covid19Phase 1/2ACTNCT04681092
Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study
A Phase 1/2 study testing AKS-452 in people with Covid19, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- AKS-452
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Apr 2021to 10 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
Read the detailed description
The study is designed as a combinatorial single-center open-label phase I and II clinical study design:
- 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.
- Conditions
- Covid19
- Being tested
- AKS-452
- Keywords
- vaccine, safety, immunogenicity, dose-finding, exploratory efficacy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKS-452Biological
s.c. or i.m. vaccination
| Study group | Role | What they receive |
|---|---|---|
| AKS-452 s.c.(A) | Experimental | Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose Receives: Biological: AKS-452 |
| AKS-452 s.c. (B) | Experimental | Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL), two-dose Receives: Biological: AKS-452 |
| AKS-452 s.c. (C) | Experimental | Subcutaneous injection of pre-defined dose (45 ug, 205 uL), single-dose Receives: Biological: AKS-452 |
| AKS-452 s.c. (D) | Experimental | Subcutaneous injection of pre-defined dose (45 ug, 250 uL), two-dose Receives: Biological: AKS-452 |
| AKS-452 s.c. (E) | Experimental | Subcutaneous injection of pre-defined dose (90 ug, 500 uL), single-dose Receives: Biological: AKS-452 |
| AKS-452 s.c. (F) | Experimental | Subcutaneous injection of pre-defined dose (90 ug, 500 uL), two-dose Receives: Biological: AKS-452 |
| Phase 2, single-dose injection | Experimental | Subcutaneous injection of selected dose based on phase 1 data, dose (90 ug, 500 uL) Receives: 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. Receives: Biological: AKS-452 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety / Tolerability
CTCAE-scoring
Measured: 35 days
Secondary outcomes (1)
Immunogenicity
Antibody response COVID-19
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start6 Apr 2021
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single-center, open-label, combinatorial safety, tolerability and exploratory efficacy
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Akston Biosciences Corporation
- Responsible party
- Sponsor
- Investigators
- Schelto Kruijff, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681092
- Sponsor's protocol ID
- NL2020-005997-82
- Acronym
- ACT
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36842886Janssen 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.
PubMed 35115195
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study
- ClinicalTrials.gov ID
- NCT04681092
- Acronym / sponsor ID
- ACT / NL2020-005997-82
- Conditions
- Covid19
- Keywords
- vaccine, safety, immunogenicity, dose-finding, exploratory efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Akston Biosciences Corporation
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
Detailed description
The study is designed as a combinatorial single-center open-label phase I and II clinical study design:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Single-center, open-label, combinatorial safety, tolerability and exploratory efficacy
| Arm | Type | Receives |
|---|---|---|
| AKS-452 s.c.(A) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose |
| AKS-452 s.c. (B) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL), two-dose |
| AKS-452 s.c. (C) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (45 ug, 205 uL), single-dose |
| AKS-452 s.c. (D) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (45 ug, 250 uL), two-dose |
| AKS-452 s.c. (E) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (90 ug, 500 uL), single-dose |
| AKS-452 s.c. (F) | Experimental | Biological: AKS-452Subcutaneous injection of pre-defined dose (90 ug, 500 uL), two-dose |
| Phase 2, single-dose injection | Experimental | Biological: AKS-452Subcutaneous injection of selected dose based on phase 1 data, dose (90 ug, 500 uL) |
| Phase 2, two-dose injection | Experimental | Biological: AKS-452Subcutaneous injection of selected dose based on phase 1 data, dose (45 ug, 500 uL) twice. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Undetectable or < 5 μg/mL titer and no known prior SARS-Cov-2 infection
- Note: one retest of vital functions and ECG is allowed within the screening window
- Note: one retest of lab tests is allowed within the screening window
- 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);
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKS-452s.c. or i.m. vaccination | Biological | 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 |
Primary outcome
Safety / Tolerability
Time frame: 35 days
CTCAE-scoring
1 secondary outcome
Immunogenicity
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 36842886Feitsma 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.
- Derived from this study: PubMed 35115195Janssen 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.
- Scientific manuscript phase I clinical study AKS-452Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schelto Kruijff, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AKS-452 in people with Covid19, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety / Tolerability (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04681092, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.