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Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study) (ACT-BOOSTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05124483
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : May 20, 2022
Sponsor:
Collaborators:
TRACER Europe BV
PRA Health Sciences
Information provided by (Responsible Party):
Schelto Kruijff, MD PhD, University Medical Center Groningen

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AKS-452X Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study)
Actual Study Start Date : April 21, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pfizer [Comirnaty]
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.
Biological: AKS-452X
subcutaneous injection of 90 µg AKS-452X

Experimental: Moderna [Spikevax]
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.
Biological: AKS-452X
subcutaneous injection of 90 µg AKS-452X

Experimental: Janssen [Ad26.COV2.S]
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.
Biological: AKS-452X
subcutaneous injection of 90 µg AKS-452X

Experimental: AstraZeneca [Vaxzevria])
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.
Biological: AKS-452X
subcutaneous injection of 90 µg AKS-452X




Primary Outcome Measures :
  1. 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 (%)).


Secondary Outcome Measures :
  1. Safety evaluation [ Time Frame: 9 months post-injection of the booster AKS-452X ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

    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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124483


Contacts
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Contact: Gooitzen M van Dam, MD, PhD 31-6-22914614 g.m.van.dam@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Gooitzen M van Dam, MD, PhD    +31622914614    g.m.van.dam@umcg.nl   
Principal Investigator: Schelto Kruijff, MD, PhD         
Sub-Investigator: Hendrikus H Boersma, PharmD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
TRACER Europe BV
PRA Health Sciences
Investigators
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Study Chair: Gooitzen M van Dam, MD, PhD University Medical Center Groningen
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Responsible Party: Schelto Kruijff, MD PhD, prof dr, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT05124483    
Other Study ID Numbers: 900452-CT-21-001
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Schelto Kruijff, MD PhD, University Medical Center Groningen:
COVID-19
Vaccine
Booster
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases