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Dendritic Cell Vaccine to Prevent COVID-19

NCT ID: NCT04685603

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2022-01-31

Brief Summary

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This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.

Detailed Description

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Subjects eligible for treatment will be those who at baseline, are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARSCoV- 2 based on serologic testing, and give informed consent for a vaccination with AV-COVID-19. The patient population will include the elderly and others at higher risk for poor outcomes after COVID-19 infection. For this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease.

After enrolling for screening, subjects will undergo a nasal swab test to exclude active COVID-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-SARS-CoV-2 antibodies. 50 mL of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into DC before incubation with SARS-CoV-2 S-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of DC in conjunction with histocompatibility class I and class II molecules. Safety and quality testing will be performed on a small quantity of the batch, and the remaining AV-COVID-19 will be cryopreserved for shipping to the treatment site.

Once the Study Drug is ready, if eligible, the subject will be seen at Study Week-0 for treatment. Prior to injection of the Study Drug, a nasal swab test will be collected to confirm that they are still negative for COVID-19, and blood will be drawn to determine baseline levels of anti-SARS-CoV-2 antibodies. At the treatment site, the product will be thawed and admixed with saline or (saline with GM-CSF), and within 5 hours of thawing, will be injected SC via a 25- gauge needle

Conditions

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COVID-19

Keywords

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covid-19 vaccine dendritic cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF)

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF)

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF)

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF)

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF)

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF)

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF)

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF)

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

Interventions

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AV-COVID-19

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older,
2. in relatively good health with adequate physical and mental function
3. including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2

Exclusion Criteria

1. Active COVID-19 infection by PCR testing
2. Pre-existing IgG or IgM SARS-CoV-2 antibodies
3. Pregnant, Known hypersensitivity to GM-CSF
4. Known active immune deficiency disease or active HIV
5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
6. Participated in previous COVID-19 vaccine study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aivita Biomedical, Inc.

INDUSTRY

Sponsor Role collaborator

PT AIVITA Biomedika Indonesia

UNKNOWN

Sponsor Role collaborator

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

OTHER

Sponsor Role collaborator

RSUP Dr. Kariadi Semarang, indonesia

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine University of Diponegoro, Indonesia

UNKNOWN

Sponsor Role collaborator

Indonesia-MoH

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Djoko Wibisono, Dr. Internis

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta

Muhammad Karyana

Role: PRINCIPAL_INVESTIGATOR

National Institute of Health Research and Development

Locations

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Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Muhammad Karyana, Dr., MPH

Role: CONTACT

Phone: +62 21 4261088

Email: [email protected]

Facility Contacts

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Muchlis Achsan Udji Sofro, MD, Internis

Role: primary

Other Identifiers

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U1111-1263-0568

Identifier Type: OTHER

Identifier Source: secondary_id

CL-COV-P02-ID

Identifier Type: -

Identifier Source: org_study_id