Dendritic Cell Vaccine to Prevent COVID-19

Indonesia-MoH27 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

COVID-19

Interventions

AV-COVID-19BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, Indonesia

RECRUITING

Outcomes

Primary Outcomes

Frequency of solicited local and systemic reactogenicity adverse events (AEs)

Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.

Time frame: until follow up day 7

Safety Laboratory Values (Serum Chemistry)

Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

Time frame: until follow up day 7

Safety Laboratory Values (Hematology)

Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

Time frame: until follow up day 7

Frequency of any serious adverse events (SAEs)

Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events

Time frame: until follow up day 365

Frequency of any new-onset chronic medical conditions (NOCMCs)

NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination

Time frame: until follow up day 365

Frequency of medically attended adverse events (MAAEs)

Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.

Time frame: until follow up day 365

Central Contacts

Muhammad Karyana, Dr., MPH

CONTACT

+62 21 4261088 mkaryana@gmail.com

Data from ClinicalTrials.gov

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Secondary Outcomes

Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)

Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.