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

NCT05007496 | Completed Phase 2 DMC

• 1 other identifier: CL-COV-P02-ID
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• Efficacy based on T-cell-induced immune response

  ELISPOT assay at baseline, week 2 and week 4 post-vaccination

  4 weeks

Secondary Outcomes (2)

• Adverse event frequency and incidence

  4 weeks

• Optimal formulation

  4 weeks

Study Arms (3)

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

EXPERIMENTAL

DCL previously incubated with 0.1 mcg spike protein

Biological: AV-COVID-19

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

EXPERIMENTAL

DCL previously incubated with 0.33 mcg spike protein

Biological: AV-COVID-19

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

EXPERIMENTAL

DCL previously incubated with 1.0 mcg spike protein

Biological: AV-COVID-19

Interventions

AV-COVID-19 BIOLOGICAL

DCL previously loaded with varying quantity of S-protein

AV-COVID-19 (0.1 mcg S-protein); AV-COVID-19 (0.33 mcg S-protein); AV-COVID-19 (1.0 mcg S-protein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aivita Biomedical, Inc.: lead
• PT AIVITA Biomedika Indonesia: collaborator
• Kariadi Hospital: collaborator
• Central Army Hospital RSPAD Gatot Soebroto: collaborator

Study Sites (1)

RSPAD Gatot Soebroto

Jakarta, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

AV-COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr Jonny, SpPD-KGH, MKes, MM

  Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 16, 2021
• Study Start: April 14, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

ID (1)