Dendritic cell vaccine to prevent COVID-19
| ISRCTN | ISRCTN14037053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14037053 |
| ClinicalTrials.gov (NCT) | NCT04685603 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UTN U1111-1263-0568, CL-COV-P02-ID |
| Sponsor | Ministry of Health |
| Funder | Ministry of Health, Republic of Indonesia |
- Submission date
- 25/12/2020
- Registration date
- 31/12/2020
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
This study aims to test a vaccine for COVID-19 that contains a SARS-CoV-2 S-protein.
Who can participate?
Subjects eligible for treatment will be those who are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARS-CoV-2, and give informed consent for a vaccination with AV-COVID-19.
What does the study involve?
Participants will first be screened for COVID-19 infection and have some blood taken. Then participants will be randomly allocated to receive the experimental vaccine at one of 9 different doses. Participants will be followed up for 28 days.
What are the possible benefits and risks of participating?
You may not benefit medically from participating in this study, but it is hoped that the AV-COVID-19 vaccine will induce your immune system to produce antibodies against SARS-CoV-2 S-protein that may prevent a COVID-19 infection from occurring in the future.
With this investigational product and the periodic exposure to GM-CSF, the most common side effects include mild to moderate local injection site reaction (80%; e.g., irritation/pain, redness of the skin, itching), flu-like symptoms (15%; e.g., fatigue, headache, body aches, low-grade fever), and bone discomfort (10%) that resolve in 24 to 72 hours. Occasionally, patients experienced hives and/or redness or tenderness at the site of a previous injection, or elsewhere on the body. These effects typically go away over a few hours to days and seldom require medical attention.
As with taking any drug, there is a risk of an allergic reaction. Should a significant allergic reaction occur, your health care team may prescribe agents to relieve the symptoms.
There could be unanticipated toxicities or side effects from these study therapies.
Where is the study run from?
Dr Kariadi Hospital (Indonesia)
When is the study starting and how long is it expected to run for?
November 2020 to January 2022
Who is funding the study?
Indonesia Ministry of Health
Who is the main contact?
Dr Muhammad Karyana, mkaryana@gmail.com
Contact information
Public
National Institute of Health Research and Development
Ministry of Health
Jl. Percetakan Negara No. 29
Jakarta
10560
Indonesia
 ORCID ID |
0000-0002-7785-5731 |
|---|---|
| Phone | +62 816789817 |
| muhammad.karyana@kemkes.go.id |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Adaptive phase I clinical trial of a preventive vaccine consisting of autologous dendritic cells previously incubated with S-protein from SARS-CoV-2, in subjects negative for COVID-19 infection and anti-SARS-CoV-2 antibodies |
| Study objectives | The aim of the study is to trial a preventive vaccine consisting of autologous dendritic cells previously incubated with S-protein from SARS-CoV-2 |
| Ethics approval(s) | Approved 26/11/2020, Health Research Ethics Committee Central Army Hospital RSPAD Gatot Soebroto (Jl. Abdul Rahman Saleh No. 24 Jakarta Pusat 10410; +6221-3441008; kepkrspad@gmail.com), ref: 06/XI/KEPK/2020 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) vaccine |
| Intervention | Participants are randomly allocated to receive AV-COVID-19 in 9 arms: 1. 0.1 mg antigen, 0 mcg GMCSF 2. 0.33 mg antigen, 0 mcg GMCSF 3. 1.0 mg antigen, 0 mcg GMCSF 4. 0.1 mg antigen, 250 mcg GMCSF 5. 0.33 mg antigen, 250 mcg GMCSF 6. 1.0 mg antigen, 250 mcg GMCSF 7. 0.1 mg antigen, 500 mcg GMCSF 8. 0.33 mg antigen, 500 mcg GMCSF 9. 1.0 mg antigen, 500 mcg GMCSF Randomisation will occur using a 3 x 3 matrix. Because of blocking after enrollment of each set of nine subjects, all 27 of these subjects will have received an injection of autologous AV-COVID-19 that was incubated with one of three different quantities of S-protein, 9 subjects will have received autologous AV-COVID-19 that was incubated with each of the three different quantities of S protein, and 3 subjects will have received an injection for each of the 9 separate conditions defined by the 3 x 3 matrix. The subjects and the medical personnel will not know what is being injected. The pharmacist will know whether the product has been admixed in GM-CSF or not. After enrolling for screening, subjects will undergo a nasal swab test to exclude active COVID-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-SARS-CoV-2 antibodies. 50 mL of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into DC before incubation with SARS-CoV-2 S-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of DC in conjunction with histocompatibility class I and class II molecules. Safety and quality testing will be performed on a small quantity of the batch, and the remaining AV-COVID-19 will be cryopreserved for shipping to the treatment site. Once the Study Drug is ready, if eligible, the subject will be seen at Study Week-0 for treatment. Prior to injection of the Study Drug, a nasal swab test will be collected to confirm that they are still negative for COVID-19, and blood will be drawn to determine baseline levels of anti-SARS-CoV-2 antibodies. At the treatment site, the product will be thawed and admixed with saline or (saline with GM-CSF), and within 5 hours of thawing, will be injected SC via a 25-gauge needle. |
| Intervention type | Biological/Vaccine |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | AV-COVID-19 |
| Primary outcome measure(s) |
Each of the following will be measured from the daily log and patient report: |
| Key secondary outcome measure(s) |
1. Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) expressed as Geometric Mean Fold Rises (GMFRs) as detected by ELISA expressed as GMFRs at 28 days |
| Completion date | 31/01/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 27 |
| Key inclusion criteria | 1. 18 years or older 2. In relatively good health with adequate physical and mental function 3. Increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2 |
| Key exclusion criteria | 1. Active COVID-19 infection by PCR testing 2. Pre-existing IgG or IgM SARS-CoV-2 antibodies 3. Pregnant, Known hypersensitivity to GM-CSF 4. Known active immune deficiency disease or active HIV 5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent 6. Participated in previous COVID-19 vaccine study |
| Date of first enrolment | 07/12/2020 |
| Date of final enrolment | 31/01/2021 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Randusari
Kec. Semarang Selatan
Semarang, Jawa Tengah
50244
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data will become available beginning 9 months and ending 36 months following article publication. Individual participant data that underlie the results reported in this article will be shared after deidentification (text, tables, figures, and appendices). Data will be shared with researchers who provide a methodologically sound proposal in order to achieve the aims in the approved proposal. Proposals should be directed to muhammad.karyana@kemkes.go.id. To gain access, data requestors will need to sign a data access agreement |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/12/2020: Trial’s existence confirmed by Health Research Ethics Committee Central Army Hospital RSPAD Gatot Soebroto
