COVID-19Phase 2NCT05007496
Preventive Dendritic Cell Vaccine, AV-COVID-19, in Subjects Not Actively Infected With COVID-19
A Phase 2 study testing AV-COVID-19 in people with COVID-19, run by Aivita Biomedical, Inc. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AV-COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Apr 2021to 31 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- AV-COVID-19
- Keywords
- Prevention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-COVID-19Biological
DCL previously loaded with varying quantity of S-protein
| Study group | Role | What they receive |
|---|---|---|
| AV-COVID-19 (0.1 mcg S-protein) | Experimental | DCL previously incubated with 0.1 mcg spike protein Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (0.33 mcg S-protein) | Experimental | DCL previously incubated with 0.33 mcg spike protein Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (1.0 mcg S-protein) | Experimental | DCL previously incubated with 1.0 mcg spike protein Receives: Biological: AV-COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on T-cell-induced immune response
ELISPOT assay at baseline, week 2 and week 4 post-vaccination
Measured: 4 weeks
Secondary outcomes (2)
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
Measured: 4 weeks
Optimal formulation
Choose the optimal formulation (0.1, 0.33, 1.0 mcg S-protein)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start14 Apr 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aivita Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT AIVITA Biomedika Indonesia, Kariadi Hospital, Central Army Hospital RSPAD Gatot Soebroto
- Responsible party
- Sponsor
- Investigators
- Dr Jonny, SpPD-KGH, MKes, MM, Principal investigator, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007496
- Sponsor's protocol ID
- CL-COV-P02-ID
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05007496
- Acronym / sponsor ID
- CL-COV-P02-ID
- Conditions
- COVID-19
- Keywords
- Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Aivita Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PT AIVITA Biomedika Indonesia, Kariadi Hospital, Central Army Hospital RSPAD Gatot Soebroto
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AV-COVID-19 (0.1 mcg S-protein) | Experimental | Biological: AV-COVID-19DCL previously incubated with 0.1 mcg spike protein |
| AV-COVID-19 (0.33 mcg S-protein) | Experimental | Biological: AV-COVID-19DCL previously incubated with 0.33 mcg spike protein |
| AV-COVID-19 (1.0 mcg S-protein) | Experimental | Biological: AV-COVID-19DCL previously incubated with 1.0 mcg spike protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-COVID-19DCL previously loaded with varying quantity of S-protein | Biological | AV-COVID-19 (0.1 mcg S-protein), AV-COVID-19 (0.33 mcg S-protein), AV-COVID-19 (1.0 mcg S-protein) |
Primary outcome
Efficacy based on T-cell-induced immune response
Time frame: 4 weeks
ELISPOT assay at baseline, week 2 and week 4 post-vaccination
2 secondary outcomes
Adverse event frequency and incidence
Time frame: 4 weeks
Optimal formulation
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Jonny, SpPD-KGH, MKes, MM principal investigator
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV-COVID-19 in people with COVID-19, run by Aivita Biomedical, Inc. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on T-cell-induced immune response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.