Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection

COVID-19 Clinical Trial

Official title:

Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690387
• Other study ID #: CL-COV-P01-ID
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: December 2021
• Source: Aivita Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 SARS-CoV- 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 15, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection

Exclusion Criteria:

• Active COVID-19 infection by PCR testing, pre-existing SARS-CoV-2 antibodies, pregnant, known hypersensitivity to GM-CSF, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous COVID-19 trial

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

Other:
• GM-CSF
GM-CSF as an adjuvant

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Umum Pusat Dr. Kariadi	Semarang	Jawa Tengah

Sponsors (4)

Lead Sponsor	Collaborator
Aivita Biomedical, Inc.	Indonesia Ministry of Health, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, PT AIVITA Biomedika Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (safety)	Collection of adverse event incidence and severity in all treatment arms	1 week
Secondary	Establish optimal dose formulation	Measurement of antibodies in subject blood	1 month
Secondary	Duration of detection of antibodies against SARS-CoV-2	Measurement of antibodies in subject blood	1 month