COVID-19 Clinical Trial
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
Verified date | August 2021 |
Source | Aivita Biomedical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSPAD Gatot Soebroto | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Aivita Biomedical, Inc. | Central Army Hospital RSPAD Gatot Soebroto, Kariadi Hospital, PT AIVITA Biomedika Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy based on T-cell-induced immune response | ELISPOT assay at baseline, week 2 and week 4 post-vaccination | 4 weeks | |
Secondary | 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 | 4 weeks | |
Secondary | Optimal formulation | Choose the optimal formulation (0.1, 0.33, 1.0 mcg S-protein) | 4 weeks |
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