COVID-19Phase 2ACT-BOOSTERNCT05124483
Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study)
A Phase 2 study testing AKS-452X in people with COVID-19, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Aim: To investigate if a subcutaneous (s.c.) booster dose of 90 µg of the naked Akston AKS-452 vaccine (AKS-452X) at >= 3 months post initial vaccination, with any of the four registered vaccines, will boost the antibody titer and immune response in human healthy volunteers 4-6 weeks after s.c. injection. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AKS-452X
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Apr 2022to 1 Feb 2023
- Phase
- Phase 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 18-85 years (extremes included), males and females.
- Negative SARS-CoV-2 serology (an anti-SARS-CoV-2 SP-specific IgG ELISA)
- 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
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- o 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 have received a completed (registered) vaccine at least 3 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:
- At least 1 year post-menopausal (amenorrhea >12 months
- 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
- 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.
- Note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at the dosing visit, in all women.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 RB
Gooitzen M van Dam, MD, PhD, +31622914614, g.m.van.dam@umcg.nl
Schelto Kruijff, MD, PhD
About this study
Aim: To investigate if a subcutaneous (s.c.) booster dose of 90 µg of the naked Akston AKS-452 vaccine (AKS-452X) at >= 3 months post initial vaccination, with any of the four registered vaccines, will boost the antibody titer and immune response in human healthy volunteers 4-6 weeks after s.c. injection.
Read the detailed description
Hypothesis: A booster dose of naked (i.e. non-adjuvanted) AKS-452 vaccine will provide an enhanced immune response after vaccination with any of the registered vaccines against COVID-19.
Primary objective: To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of AKS-452X vaccine given at >=3 months post-initial vaccination (i.e. Pfizer [ Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S], AstraZeneca [Vaxzevria]) in human healthy volunteers.
Secondary objective: Vaccine safety and side effects after booster vaccination. Follow-up will occur for up to 9 months post-study vaccine.
Study design: Single center, open-label, safety and efficacy study on the biological activity of a SP/RBD-Fc antigen booster vaccine (AKS-452X) against COVID-19.
Study population: Healthy human volunteers, 18 - 85 years, having received a registered vaccine (i.e. Pfizer [Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S], AstraZeneca [Vaxzevria]).
Intervention: One booster dose-level of naked AKS-452 (90 µg) administered via s.c. route in 150 subjects per cohort in which safety parameters and neutralizing IgG titers will be reviewed after the booster dose of 90 µg s.c.. Enhanced immune response is defined as: i) seroconversion based on a true positive based on the SP/RBD IgG ELISA assay positive/negative cutoff criteria using the quantitative cut-off value defined by the assay kit batch expressed in μg/mL. The positive/negative cutoff value was established as 2.42 µg/mL from the validation analysis for the current lot of assay kits, but it should be noted that for each new lot of assay kits, Akston QC performs a re-validation of the cutoff value in order to maintain clinical agreement from lot-to-lot, ii) two times (2x) the baseline SP/RBD IgG at day 56 after a boostering, as compared to the titer at the time of screening.
Main study parameters/endpoints: Primary endpoint: The percentage of patients that i) achieve an SP/RBD-specific IgG antibody titer level of ≥ 2.42 µg/mL at the day 28 time-point post-intervention (i.e. booster vaccine) if the base-line value prior to receiving the booster vaccine was < 2.42 µg/mL or ii) where the SP/RBD-specific IgG antibody titer is at least 2x the base-line value prior to receiving the booster vaccine if the base-line value prior to receiving the booster vaccine was ≥ 2.42 µg/mL. The percentage of patients in each of the four cohorts that achieve the primary endpoint threshold at 28 days post-intervention will be calculated (n (%)). Secondary endpoint: Safety evaluation in the four cohorts for local and systemic adverse events after injection at each pre-defined scheduled follow-up (at 28, 56, 91, 182 and 238 days post intervention). Patients will continue to be followed passively for additional safety events out to 9 months post-intervention.
- Conditions
- COVID-19
- Being tested
- AKS-452X
- Keywords
- COVID-19, Vaccine, Booster
- 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-452XBiological
subcutaneous injection of 90 µg AKS-452X
| Study group | Role | What they receive |
|---|---|---|
| Pfizer [Comirnaty] | Experimental | To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Pfizer [Comirnaty] vaccine. Receives: Biological: AKS-452X |
| Moderna [Spikevax] | Experimental | To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Moderna [Spikevax] vaccine. Receives: Biological: AKS-452X |
| Janssen [Ad26.COV2.S] | Experimental | To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Janssen [Ad26.COV2.S] vaccine. Receives: Biological: AKS-452X |
| AstraZeneca [Vaxzevria]) | Experimental | To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered AstraZeneca [Vaxzevria]) vaccine. Receives: Biological: AKS-452X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced Immune Response
The percentage of patients that i) achieve an SP/RBD-specific IgG antibody titer level of ≥ 2.42 µg/mL at the day 28 time-point post-intervention (i.e. booster vaccine) if the base-line value prior to receiving the booster vaccine was < 2.42 µg/mL or ii) where the SP/RBD-specific IgG antibody titer is at least 2x the base-line value prior to receiving the booster vaccine if the base-line value prior to receiving the booster vaccine was ≥ 2.42 µg/mL. The percentage of patients in each of the four cohorts that achieve the primary endpoint threshold at 28 days post-intervention will be calculated (n (%)).
Measured: 28 days post-injection of the booster AKS-452X
Secondary outcomes (1)
Safety evaluation
Safety evaluation in the four cohorts for local and systemic adverse events after injection at each pre-defined scheduled follow-up (at 28, 56, 91, 182 and 238 days post intervention). Patients will continue to be followed passively for additional safety events out to 9 months post-intervention.
Measured: 9 months post-injection of the booster AKS-452X
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start21 Apr 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single center, open-label, safety and efficacy study on the biological activity of a SP/RBD-Fc antigen booster vaccine (AKS-452X) against COVID-19.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- TRACER Europe BV, PRA Health Sciences
- Responsible party
- Principal investigator, Schelto Kruijff, MD PhD, University Medical Center Groningen
- Investigators
- Gooitzen M van Dam, MD, PhD, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124483
- Sponsor's protocol ID
- 900452-CT-21-001
- Acronym
- ACT-BOOSTER
- Status last verified
- May 2022
- First submitted
- 17 Nov 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study)
- ClinicalTrials.gov ID
- NCT05124483
- Acronym / sponsor ID
- ACT-BOOSTER / 900452-CT-21-001
- Conditions
- COVID-19
- Keywords
- COVID-19, Vaccine, Booster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- TRACER Europe BV, PRA Health Sciences
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 18 Nov 2021 (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.
Aim: To investigate if a subcutaneous (s.c.) booster dose of 90 µg of the naked Akston AKS-452 vaccine (AKS-452X) at >= 3 months post initial vaccination, with any of the four registered vaccines, will boost the antibody titer and immune response in human healthy volunteers 4-6 weeks after s.c. injection.
Detailed description
Hypothesis: A booster dose of naked (i.e. non-adjuvanted) AKS-452 vaccine will provide an enhanced immune response after vaccination with any of the registered vaccines against COVID-19.
Primary objective: To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of AKS-452X vaccine given at >=3 months post-initial vaccination (i.e. Pfizer [ Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S], AstraZeneca [Vaxzevria]) in human healthy volunteers.
Secondary objective: Vaccine safety and side effects after booster vaccination. Follow-up will occur for up to 9 months post-study vaccine.
Study design: Single center, open-label, safety and efficacy study on the biological activity of a SP/RBD-Fc antigen booster vaccine (AKS-452X) against COVID-19.
Study population: Healthy human volunteers, 18 - 85 years, having received a registered vaccine (i.e. Pfizer [Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S], AstraZeneca [Vaxzevria]).
Intervention: One booster dose-level of naked AKS-452 (90 µg) administered via s.c. route in 150 subjects per cohort in which safety parameters and neutralizing IgG titers will be reviewed after the booster dose of 90 µg s.c.. Enhanced immune response is defined as: i) seroconversion based on a true positive based on the SP/RBD IgG ELISA assay positive/negative cutoff criteria using the quantitative cut-off value defined by the assay kit batch expressed in μg/mL. The positive/negative cutoff value was established as 2.42 µg/mL from the validation analysis for the current lot of assay kits, but it should be noted that for each new lot of assay kits, Akston QC performs a re-validation of the cutoff value in order to maintain clinical agreement from lot-to-lot, ii) two times (2x) the baseline SP/RBD IgG at day 56 after a boostering, as compared to the titer at the time of screening.
Main study parameters/endpoints: Primary endpoint: The percentage of patients that i) achieve an SP/RBD-specific IgG antibody titer level of ≥ 2.42 µg/mL at the day 28 time-point post-intervention (i.e. booster vaccine) if the base-line value prior to receiving the booster vaccine was < 2.42 µg/mL or ii) where the SP/RBD-specific IgG antibody titer is at least 2x the base-line value prior to receiving the booster vaccine if the base-line value prior to receiving the booster vaccine was ≥ 2.42 µg/mL. The percentage of patients in each of the four cohorts that achieve the primary endpoint threshold at 28 days post-intervention will be calculated (n (%)). Secondary endpoint: Safety evaluation in the four cohorts for local and systemic adverse events after injection at each pre-defined scheduled follow-up (at 28, 56, 91, 182 and 238 days post intervention). Patients will continue to be followed passively for additional safety events out to 9 months post-intervention.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single center, open-label, safety and efficacy study on the biological activity of a SP/RBD-Fc antigen booster vaccine (AKS-452X) against COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Pfizer [Comirnaty] | Experimental | Biological: AKS-452XTo determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Pfizer [Comirnaty] vaccine. |
| Moderna [Spikevax] | Experimental | Biological: AKS-452XTo determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Moderna [Spikevax] vaccine. |
| Janssen [Ad26.COV2.S] | Experimental | Biological: AKS-452XTo determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered Janssen [Ad26.COV2.S] vaccine. |
| AstraZeneca [Vaxzevria]) | Experimental | Biological: AKS-452XTo determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of 90 µg AKS-452X vaccine given at >=3 months post-initial vaccination with the registered AstraZeneca [Vaxzevria]) vaccine. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 18-85 years (extremes included), males and females.
- Negative SARS-CoV-2 serology (an anti-SARS-CoV-2 SP-specific IgG ELISA)
- 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
Key exclusion criteria (13 listed)
- 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.
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-452Xsubcutaneous injection of 90 µg AKS-452X | Biological | AstraZeneca [Vaxzevria]), Janssen [Ad26.COV2.S], Moderna [Spikevax], Pfizer [Comirnaty] |
Primary outcome
Enhanced Immune Response
Time frame: 28 days post-injection of the booster AKS-452X
The percentage of patients that i) achieve an SP/RBD-specific IgG antibody titer level of ≥ 2.42 µg/mL at the day 28 time-point post-intervention (i.e. booster vaccine) if the base-line value prior to receiving the booster vaccine was < 2.42 µg/mL or ii) where the SP/RBD-specific IgG antibody titer is at least 2x the base-line value prior to receiving the booster vaccine if the base-line value prior to receiving the booster vaccine was ≥ 2.42 µg/mL. The percentage of patients in each of the four cohorts that achieve the primary endpoint threshold at 28 days post-intervention will be calculated (n (%)).
1 secondary outcome
Safety evaluation
Time frame: 9 months post-injection of the booster AKS-452X
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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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.
Gooitzen M van Dam, MD, PhD study chair
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 2 study testing AKS-452X in people with COVID-19, 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 19 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gooitzen M van Dam, MD, PhD (31-6-22914614, g.m.van.dam@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced Immune Response (time frame: 28 days post-injection of the booster AKS-452X). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022.