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Preventive Dendritic Cell Vaccine, AV-COVID-19, in Subjects Not Actively Infected With COVID-19

NCT05007496 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2021-08-20

No results posted yet for this study

Summary

This is a phase 2 randomized, double-blind clinical trial testing an anti-SARS-CoV-2 COVID-19 vaccine (AV-COVID-19) made on site using PT AIVITA Biomedika Indonesia's vaccine-enabling kit for the prevention of COVID-19 infection. The product is a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes (DCL) previously incubated with a quantity of SARS-CoV-2 spike protein (S-protein) which was shown to be safe in a phase 1 study also conducted in Indonesia. In this phase 2 study, efficacy is assessed via enhanced S-protein-specific T-cell response by comparing results before and after vaccination. Safety is confirmed via laboratory values, observation and regular patient reporting.

Conditions

Interventions

BIOLOGICAL

AV-COVID-19

DCL previously loaded with varying quantity of S-protein

Sponsors & Collaborators

  • PT AIVITA Biomedika Indonesia

    collaborator UNKNOWN

  • Kariadi Hospital

    collaborator UNKNOWN

  • Central Army Hospital RSPAD Gatot Soebroto

    collaborator UNKNOWN

  • Aivita Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr Jonny, SpPD-KGH, MKes, MM · Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Indonesia

Study Locations

More Related Trials

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 NCT05007496 on ClinicalTrials.gov