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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
AV-COVID-19
Sponsored by
Aivita Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Understands and agrees to comply with research procedures and provides written informed consent
  • Physical and mental health meet criteria to participate, which includes factors associated with increased risk of exposure to SARS-CoV-2, such as age > 65, mild to moderate obesity (BMI 30-40), hypertension controlled with medication, drug controlled hyperlipidemia, diabetes controlled with medication, mild chronic lung disease
  • Vein access permits for blood collection
  • For people with reproductive ability, adequate contraception and negative pregnancy test for women

Exclusion Criteria:

  • Have active symptoms of COVID-19 infection
  • Diagnosed with COVID-19 with a positive PCR test in the past 3 months
  • Positive SARS-CoV-2 rapid antibody IgG test
  • Positive pregnancy test
  • Known to have immunodeficiency disease
  • Are taking immunosuppresive drugs and/or corticosteroids in the long term
  • Have a condition requiring oxygen supplementation
  • Previously diagnosed with invasive cancer and receiving anti-cancer therapy in addition to hormonal therapy for breast or prostate cancer
  • History of thromboembolism or genetic predisposition to thromboembolism, or being on anti-thromboembolic therapy other than low-dose aspirin
  • Physical or mental disability that prevents you from carrying out normal daily activities
  • In the Investigator's judgement, have illnesses or medical conditions that could preclude participation
  • Excessive obesity: BMI > 40
  • Uncontrolled hypertension: systolic > 180, diastolic > 100
  • Not willing to sign written consent

Sites / Locations

  • RSPAD Gatot Soebroto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AV-COVID-19 (0.1 mcg S-protein)

AV-COVID-19 (0.33 mcg S-protein)

AV-COVID-19 (1.0 mcg S-protein)

Arm Description

DCL previously incubated with 0.1 mcg spike protein

DCL previously incubated with 0.33 mcg spike protein

DCL previously incubated with 1.0 mcg spike protein

Outcomes

Primary Outcome Measures

Efficacy based on T-cell-induced immune response
ELISPOT assay at baseline, week 2 and week 4 post-vaccination

Secondary Outcome Measures

Adverse event frequency and incidence
Confirm safety of AV-COVID-19 via laboratory values and adverse event reporting from baseline to 28-days post-vaccination
Optimal formulation
Choose the optimal formulation (0.1, 0.33, 1.0 mcg S-protein)

Full Information

First Posted
August 11, 2021
Last Updated
August 16, 2021
Sponsor
Aivita Biomedical, Inc.
Collaborators
PT AIVITA Biomedika Indonesia, Kariadi Hospital, Central Army Hospital RSPAD Gatot Soebroto
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1. Study Identification

Unique Protocol Identification Number
NCT05007496
Brief Title
Preventive Dendritic Cell Vaccine, AV-COVID-19, in Subjects Not Actively Infected With COVID-19
Official Title
Phase II Randomized Double Blind Clinical Trial Three Preventive Vaccine Formulations Consisting of Autologous Dendritic Cells and Lymphocytes Incubated With Different Quantities of Spike Protein Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), in Subjects Not Proven Actively Infected or Never Infected With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aivita Biomedical, Inc.
Collaborators
PT AIVITA Biomedika Indonesia, Kariadi Hospital, Central Army Hospital RSPAD Gatot Soebroto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
In this phase 2 study, a single dose of AV-COVID-19 DCL vaccine is injected subcutaneously in the forearm (left or right) at week 0 (day-0), to facilitate inspection and avoid confusion of local post-injection reactions or shoulder pain. Follow-up visits to assess safety are performed at 1, 2, and 4 weeks after vaccination, with laboratory safety tests performed at weeks 1 and 4, and only at week 2 if any clinically significant changes at screening up to week 1. At each visit, the injection site is assessed, and the subject is asked about symptoms, and at weeks 0 (baseline before injection), 2 and 4, blood is drawn for immunogenicity testing. Reaction data at the injection site and safety profile are obtained by telephone to subjects on days 1, 2, and 3 after vaccine injection. Subjects are asked specifically about local injection site reactions and systemic flu-like symptoms (fever, chills, muscle aches, joint pain) for 7 days after injection. Adverse events (AE) are collected for 28 days after injection. Evaluation of laboratory tests for clinical safety parameters are carried out at screening as well as immediately before vaccination and on day 7 and day 28 post-vaccination. Serious adverse events (SAE), recent medical conditions, and other events requiring medical intervention are recorded for 2 months after vaccination. Vaccine enabling kits are made by PT AIVITA Biomedika Indonesia. All vaccines are made in Indonesia on site at participating hospitals and clinical sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV-COVID-19 (0.1 mcg S-protein)
Arm Type
Experimental
Arm Description
DCL previously incubated with 0.1 mcg spike protein
Arm Title
AV-COVID-19 (0.33 mcg S-protein)
Arm Type
Experimental
Arm Description
DCL previously incubated with 0.33 mcg spike protein
Arm Title
AV-COVID-19 (1.0 mcg S-protein)
Arm Type
Experimental
Arm Description
DCL previously incubated with 1.0 mcg spike protein
Intervention Type
Biological
Intervention Name(s)
AV-COVID-19
Intervention Description
DCL previously loaded with varying quantity of S-protein
Primary Outcome Measure Information:
Title
Efficacy based on T-cell-induced immune response
Description
ELISPOT assay at baseline, week 2 and week 4 post-vaccination
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse event frequency and incidence
Description
Confirm safety of AV-COVID-19 via laboratory values and adverse event reporting from baseline to 28-days post-vaccination
Time Frame
4 weeks
Title
Optimal formulation
Description
Choose the optimal formulation (0.1, 0.33, 1.0 mcg S-protein)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Understands and agrees to comply with research procedures and provides written informed consent Physical and mental health meet criteria to participate, which includes factors associated with increased risk of exposure to SARS-CoV-2, such as age > 65, mild to moderate obesity (BMI 30-40), hypertension controlled with medication, drug controlled hyperlipidemia, diabetes controlled with medication, mild chronic lung disease Vein access permits for blood collection For people with reproductive ability, adequate contraception and negative pregnancy test for women Exclusion Criteria: Have active symptoms of COVID-19 infection Diagnosed with COVID-19 with a positive PCR test in the past 3 months Positive SARS-CoV-2 rapid antibody IgG test Positive pregnancy test Known to have immunodeficiency disease Are taking immunosuppresive drugs and/or corticosteroids in the long term Have a condition requiring oxygen supplementation Previously diagnosed with invasive cancer and receiving anti-cancer therapy in addition to hormonal therapy for breast or prostate cancer History of thromboembolism or genetic predisposition to thromboembolism, or being on anti-thromboembolic therapy other than low-dose aspirin Physical or mental disability that prevents you from carrying out normal daily activities In the Investigator's judgement, have illnesses or medical conditions that could preclude participation Excessive obesity: BMI > 40 Uncontrolled hypertension: systolic > 180, diastolic > 100 Not willing to sign written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Jonny, SpPD-KGH, MKes, MM
Organizational Affiliation
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSPAD Gatot Soebroto
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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