NCT04690387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

1 month

First QC Date

December 28, 2020

Last Update Submit

December 14, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events (safety)

    Collection of adverse event incidence and severity in all treatment arms

    1 week

Secondary Outcomes (2)

  • Establish optimal dose formulation

    1 month

  • Duration of detection of antibodies against SARS-CoV-2

    1 month

Study Arms (9)

0.1 mg antigen, 0 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.1 mcg antigen

Biological: AV-COVID-19

0.33 mg antigen, 0 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.33 mcg antigen

Biological: AV-COVID-19

1.0 mg antigen, 0 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 1.0 mcg antigen

Biological: AV-COVID-19

0.1 mg antigen, 250 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

0.33 mg antigen, 250 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

1.0 mg antigen, 250 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

0.1 mg antigen, 500 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

0.33 mg antigen, 500 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

1.0 mg antigen, 500 mcg GM-CSF

EXPERIMENTAL

Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19Other: GM-CSF

Interventions

AV-COVID-19BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

0.1 mg antigen, 0 mcg GM-CSF0.1 mg antigen, 250 mcg GM-CSF0.1 mg antigen, 500 mcg GM-CSF0.33 mg antigen, 0 mcg GM-CSF0.33 mg antigen, 250 mcg GM-CSF0.33 mg antigen, 500 mcg GM-CSF1.0 mg antigen, 0 mcg GM-CSF1.0 mg antigen, 250 mcg GM-CSF1.0 mg antigen, 500 mcg GM-CSF
GM-CSFOTHER

GM-CSF as an adjuvant

0.1 mg antigen, 250 mcg GM-CSF0.1 mg antigen, 500 mcg GM-CSF0.33 mg antigen, 250 mcg GM-CSF0.33 mg antigen, 500 mcg GM-CSF1.0 mg antigen, 250 mcg GM-CSF1.0 mg antigen, 500 mcg GM-CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, 50244, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

AV-COVID-19 vaccineGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert O Dillman, MD

    Aivita Biomedical, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 30, 2020

Study Start

December 7, 2020

Primary Completion

January 13, 2021

Study Completion

January 15, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations

ID(1)