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Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults

NCT04386252 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-03

No results posted yet for this study

Summary

This is an adaptive Phase I-II 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.

Conditions

Interventions

BIOLOGICAL

AV-COVID-19

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

Sponsors & Collaborators

  • Aivita Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert O Dillman, MD · AIVITA Biomedical

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-06-30
Completion
2024-01-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386252 on ClinicalTrials.gov