COVID-19Phase 1NCT04685603
Dendritic Cell Vaccine to Prevent COVID-19
A Phase 1 study testing AV-COVID-19 in people with COVID-19, run by Indonesia-MoH at 1 site in Indonesia.
Trial summary
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults. 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
- 27 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Dec 2020to 31 Jan 2022
- Phase
- Phase 1
- 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
- 18 years or older,
- in relatively good health with adequate physical and mental function
- including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2
Who cannot join
- Active COVID-19 infection by PCR testing
- Pre-existing IgG or IgM SARS-CoV-2 antibodies
- Pregnant, Known hypersensitivity to GM-CSF
- Known active immune deficiency disease or active HIV
- HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
- Participated in previous COVID-19 vaccine study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, 50244
Muchlis Achsan Udji Sofro, MD, Internis
About this study
Official title: Adaptive Phase I Clinical Trial of 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
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
Read the detailed description
Subjects eligible for treatment will be those who at baseline, are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARSCoV- 2 based on serologic testing, and give informed consent for a vaccination with AV-COVID-19. The patient population will include the elderly and others at higher risk for poor outcomes after COVID-19 infection. For this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease.
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
- Conditions
- COVID-19
- Being tested
- AV-COVID-19
- Keywords
- covid-19, vaccine, dendritic cell
- 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
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
| Study group | Role | What they receive |
|---|---|---|
| AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF) | Experimental | Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF) | Experimental | Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19 |
| AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF) | Experimental | Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited local and systemic reactogenicity adverse events (AEs)
Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
Measured: until follow up day 7
Safety Laboratory Values (Serum Chemistry)
Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measured: until follow up day 7
Safety Laboratory Values (Hematology)
Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measured: until follow up day 7
Frequency of any serious adverse events (SAEs)
Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events
Measured: until follow up day 365
Frequency of any new-onset chronic medical conditions (NOCMCs)
NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
Measured: until follow up day 365
Frequency of medically attended adverse events (MAAEs)
Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.
Measured: until follow up day 365
Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs)
Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
Measured: until follow up day 90
Secondary outcomes (9)
Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.
Measured: until follow up day 28
Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 28.
Measured: until follow up day 28
Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
Measured: until follow up day 28
Neutralizing Antibody Activity Expressed as GMTs
Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28.
Measured: until follow up day 28
Neutralizing Antibody Activity Expressed as GMFRs
Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28.
Measured: until follow up day 28
Neutralizing Antibody Activity Expressed as SCRs
Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28.
Measured: until follow up day 28
Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways
Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Measured: until follow up day 28
Optimal dose of SARS-CoV2 antigen and GM-CSF
Measurement of IgG in subject blood after one month
Measured: until follow up month one
Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination
Measurement of IgG and neutralizing antibody in subject blood after 12 months
Measured: until follow up month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Dec 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indonesia-MoH
- Sponsor type
- Other government
- Collaborators
- Aivita Biomedical, Inc., PT AIVITA Biomedika Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, RSUP Dr. Kariadi Semarang, indonesia, Faculty of Medicine University of Diponegoro, Indonesia
- Responsible party
- Sponsor
- Investigators
- Djoko Wibisono, Dr. Internis, Principal investigator, Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, JakartaMuhammad Karyana, Principal investigator, National Institute of Health Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685603
- Sponsor's protocol ID
- CL-COV-P02-ID
- Other IDs
- U1111-1263-0568
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Phase I Clinical Trial of 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
- ClinicalTrials.gov ID
- NCT04685603
- Acronym / sponsor ID
- CL-COV-P02-ID
- Conditions
- COVID-19
- Keywords
- covid-19, vaccine, dendritic cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Indonesia-MoHOther government
- Collaborators
- Aivita Biomedical, Inc., PT AIVITA Biomedika Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, RSUP Dr. Kariadi Semarang, indonesia, Faculty of Medicine University of Diponegoro, Indonesia
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 28 Dec 2020 (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 an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
Detailed description
Subjects eligible for treatment will be those who at baseline, are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARSCoV- 2 based on serologic testing, and give informed consent for a vaccination with AV-COVID-19. The patient population will include the elderly and others at higher risk for poor outcomes after COVID-19 infection. For this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
| Arm | Type | Receives |
|---|---|---|
| AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF |
| AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF |
| AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF |
| Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF |
| AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF |
| AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF |
| AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF |
| AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF |
| AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF) | Experimental | Biological: AV-COVID-19Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older,
- in relatively good health with adequate physical and mental function
- including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2
Key exclusion criteria (6 listed)
- Active COVID-19 infection by PCR testing
- Pre-existing IgG or IgM SARS-CoV-2 antibodies
- Pregnant, Known hypersensitivity to GM-CSF
- Known active immune deficiency disease or active HIV
- HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
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-19Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein | Biological | AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF), AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF), AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF), AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF), AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF), AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF), AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF), AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF), Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF) |
Primary outcome
Frequency of solicited local and systemic reactogenicity adverse events (AEs)
Time frame: until follow up day 7
Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
Safety Laboratory Values (Serum Chemistry)
Time frame: until follow up day 7
Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Safety Laboratory Values (Hematology)
Time frame: until follow up day 7
Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Frequency of any serious adverse events (SAEs)
Time frame: until follow up day 365
Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events
Frequency of any new-onset chronic medical conditions (NOCMCs)
Time frame: until follow up day 365
NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
Frequency of medically attended adverse events (MAAEs)
Time frame: until follow up day 365
Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.
Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs)
Time frame: until follow up day 90
Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
9 secondary outcomes
Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)
Time frame: until follow up day 28
Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)
Time frame: until follow up day 28
Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)
Time frame: until follow up day 28
Neutralizing Antibody Activity Expressed as GMTs
Time frame: until follow up day 28
Neutralizing Antibody Activity Expressed as GMFRs
Time frame: until follow up day 28
Neutralizing Antibody Activity Expressed as SCRs
Time frame: until follow up day 28
Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways
Time frame: until follow up day 28
Optimal dose of SARS-CoV2 antigen and GM-CSF
Time frame: until follow up month one
Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination
Time frame: until follow up month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Djoko Wibisono, Dr. Internis principal investigator
Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta
Muhammad Karyana principal investigator
National Institute of Health Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-COVID-19 in people with COVID-19, run by Indonesia-MoH 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Karyana, Dr., MPH (+62 21 4261088, mkaryana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of solicited local and systemic reactogenicity adverse events (AEs) (time frame: until follow up day 7). The study lists 7 primary outcomes in all. 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 29 Dec 2020.