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

NCT05124483 | Unknown Phase 2 DMC

• 1 other identifier: 900452-CT-21-001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Vaccine; Booster

Outcome Measures

Primary Outcomes (1)

• 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 (%)).

  28 days post-injection of the booster AKS-452X

Secondary Outcomes (1)

• Safety evaluation

  9 months post-injection of the booster AKS-452X

Study Arms (4)

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.

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.

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.

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.

Biological: AKS-452X

Interventions

AKS-452X BIOLOGICAL

subcutaneous injection of 90 µg AKS-452X

AstraZeneca [Vaxzevria]); Janssen [Ad26.COV2.S]; Moderna [Spikevax]; Pfizer [Comirnaty]

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• TRACER Europe BV: collaborator
• PRA Health Sciences: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

COVID-19

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

• Gooitzen M van Dam, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

Gooitzen M van Dam, MD, PhD

CONTACT

31-6-22914614; g.m.van.dam@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof dr

Model Details: 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 Record Dates

• First Submitted: November 17, 2021
• First Posted: November 18, 2021
• Study Start: April 21, 2022
• Primary Completion: July 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)