COVID-19Phase 2NCT05172193
Safety & Immunogenicity of Booster SARS-CoV-2 Vaccine (Vero Cell)
A Phase 2 study testing SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated in people with COVID-19, run by PT. Kimia Farma (Persero) Tbk at 7 sites in Indonesia.
Trial summary
The 2019 Coronavirus disease outbreak (COVID-19) was first reported at the end of 2019 in Wuhan China as a severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. In less than a year, SARS-CoV-2 infection has become a pandemic and spread to almost all countries in the world, including Indonesia. 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?
- SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 7 sitesIndonesia
- Study dates
- 31 Dec 2021to 30 Sep 2023
- 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
- Adult males or females aged 18 years and above at the time of consent.
- Participants who provide a voluntarily consent to participate in the study and sign the consent form.
- Participants who have previously received homologous 2-dose of SARS-COV-2 Vaccine (either Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARS-COV-2 Vaccine, or Cominarty/Pfizer mRNA COVID-19 Vaccine) authorized for emergency use, between 6 to 12 months post second prime vaccine dose prior to Day 1.
- Participants who have negative results for swab SARS-COV-2 rapid antigen test.
Who cannot join
- Participants who are unable to follow clinical and follow-up procedures.
- Participants with acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the dosing.
- Participants with a history of PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing.
- Female who are pregnant or breastfeeding.
- Participants with a history of hypersensitivity or allergic reactions including anaphylaxis.
- Participants with immune dysfunction, including immunodeficiency disorder, or family history of such conditions, except HIV-positive participants in stable/well-controlled condition.
Show all 15Show fewer
- Participants who received chronic administration (defined as more than 14 continuous days) of immunosuppressant medication such as immunomodulator, immune-modifying drug, immunoglobulin, immunotherapy, chemotherapy, systemic corticosteroid, etc. except topical steroids or short-term oral steroids (course lasting ≤ 14 days), or blood-derived products in the last 90 days prior to dosing.
- Participants with a current clinically significant chronic and unstable cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria , that are assessed by the investigator as being clinically unstable within the prior 90 days as evidenced by:
- Hospitalization for the condition, including day surgical interventions
- New significant organ function deterioration
- Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed)
- Participants with hemophilia or people using anticoagulants who are at a risk of serious bleeding from IM injection.
- Participants with a current dependent on antipsychotic drugs and narcotic analgesics, or suspected of alcohol or drug dependency.
- Participants who have received or plans to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP).
- Participants who have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination. -
Trial locations and contacts
7 sites in 1 country.
Jarir At Thobari contact
7 sites in 1 country
Indonesia7 sites, 3 recruiting
- Completed
Universitas Udayana Hospital
Badung, Bali
- Recruiting
Kimia Farma Diponegoro Clinic and Laboratorium
Bandung, West Java
Research team
- Completed
Bali Mandara Hospital
Denpasar, Bali
- Recruiting
Kimia Farma Radio Dalam Clinic and Laboratorium
Jakarta
Research team
- Recruiting
Kimia Farma Soetomo Clinic and Laboratorium
Semarang, Central Java
Research team
- Completed
JIH Hospital
Sleman, D.I. Yogyakarta
- Completed
Kimia Farma Adisucipto Clinic and Laboratorium
Yogyakarta, D.I. Yogyakarta
About this study
Official title: A Phase II Non-Randomized Open Labelled Clinical Trial to Evaluate the Safety & Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose
The 2019 Coronavirus disease outbreak (COVID-19) was first reported at the end of 2019 in Wuhan China as a severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. In less than a year, SARS-CoV-2 infection has become a pandemic and spread to almost all countries in the world, including Indonesia. World Health Organization data states that there are 4,240,479 confirmed cases of SARS-CoV-2 in Indonesia until 25 October 2021 with a death rate of 143,235 (WHO, 2021a).
The Indonesian National Agency of Drug and Food Control (NA-DFC) has issued an Emergency Use Authorization for several SARS-COV-2 Vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (BPOM, 2021). Clinical data that the actual immune responses decrease after several months are continuously being reported (Marmot et al., 2021), and the decrease of vaccine efficacy due to the appearance of variants is also known (Abu-Raddad et al., 2021; Lopez Bernal et al., 2021). These potential risks suggest the need for a booster dose or periodic booster doses of the SARS-COV-2 Vaccine. In fact, there is a study result given several months after vaccination, which leads to the generation of a higher immune responses (Pan H et al., 2021). Booster dose of SARS-COV-2 Vaccine will either induce a high level of antibody responses against original strain, or enhance the broadly formed T cell immunity regardless of mutant strain to improve individual protection.
- Conditions
- COVID-19
- Being tested
- SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated
- Keywords
- COVID-19, Booster, Verocell Inactivated Vaccine, Immunogenicity, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-COV-2 Vaccine (Vero Cell-Sinopharm) InactivatedBiological
SARS-CoV-2 vaccine (Vero cell) inactivated developed by Beijing Bio-Institute Biological Products Co., Ltd, can induce active immunity and prevent diseases caused by the SARS-CoV-2 virus by producing neutralizing antibody. The inactivated SARSCoV-2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying and adding aluminum hydroxide adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated | Experimental | One booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated Receives: Biological: SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster dose
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster dose
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster dose
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster dose
Secondary outcomes (8)
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: At 90, 180, and 360 days after one booster
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
To evaluate the immunogenicity at 90, 180, and 360 days after one booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: At 90, 180, and 360 days after one booster
To proportion of solicited adverse events within 7 days after one booster dose
To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 7 days after one booster
To proportion of unsolicited adverse events within 28 days after one booster dose
To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster
To proportion of clinically significant abnormal liver function (AST, ALT, Total Bilirubin) at 14 days and 28 days
To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 28 days after one booster
To proportion of serious adverse events within 180 days after one booster dose
To evaluate the safety profile of one booster dose 0.5 mL IM injection of SARSCOV-2 Vaccine (Vero Cell) Inactivated in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
Measured: Within 180 days after one booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start31 Dec 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase 2, non-randomized, open-label, clinical trial to evaluate the safety and immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated up to 6 months post booster dose and a sub cohort study among vaccine arm to evaluate immunogenicity up to 12 months post booster dose in adults aged 18 years old and above who have received the 2 prime doses of one of SARSCOV-2 Vaccines (Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARSCOV-2 Vaccine, or AstraZeneca SARS-COV-2 Vaccine) authorized for emergency use (EUA) in Indonesia.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Kimia Farma (Persero) Tbk
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prenali Dwisthi Sattwika, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172193
- Sponsor's protocol ID
- BOOST-VC-0221
- Status last verified
- Sep 2022
- First submitted
- 23 Dec 2021
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Non-Randomized Open Labelled Clinical Trial to Evaluate the Safety & Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose
- ClinicalTrials.gov ID
- NCT05172193
- Acronym / sponsor ID
- BOOST-VC-0221
- Conditions
- COVID-19
- Keywords
- COVID-19, Booster, Verocell Inactivated Vaccine, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PT. Kimia Farma (Persero) TbkIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 29 Dec 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.
The 2019 Coronavirus disease outbreak (COVID-19) was first reported at the end of 2019 in Wuhan China as a severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. In less than a year, SARS-CoV-2 infection has become a pandemic and spread to almost all countries in the world, including Indonesia. World Health Organization data states that there are 4,240,479 confirmed cases of SARS-CoV-2 in Indonesia until 25 October 2021 with a death rate of 143,235 (WHO, 2021a).
The Indonesian National Agency of Drug and Food Control (NA-DFC) has issued an Emergency Use Authorization for several SARS-COV-2 Vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (BPOM, 2021). Clinical data that the actual immune responses decrease after several months are continuously being reported (Marmot et al., 2021), and the decrease of vaccine efficacy due to the appearance of variants is also known (Abu-Raddad et al., 2021; Lopez Bernal et al., 2021). These potential risks suggest the need for a booster dose or periodic booster doses of the SARS-COV-2 Vaccine. In fact, there is a study result given several months after vaccination, which leads to the generation of a higher immune responses (Pan H et al., 2021). Booster dose of SARS-COV-2 Vaccine will either induce a high level of antibody responses against original strain, or enhance the broadly formed T cell immunity regardless of mutant strain to improve individual protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase 2, non-randomized, open-label, clinical trial to evaluate the safety and immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated up to 6 months post booster dose and a sub cohort study among vaccine arm to evaluate immunogenicity up to 12 months post booster dose in adults aged 18 years old and above who have received the 2 prime doses of one of SARSCOV-2 Vaccines (Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARSCOV-2 Vaccine, or AstraZeneca SARS-COV-2 Vaccine) authorized for emergency use (EUA) in Indonesia.
| Arm | Type | Receives |
|---|---|---|
| SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated | Experimental | Biological: SARS-COV-2 Vaccine (Vero Cell-Sinopharm) InactivatedOne booster dose 0.5 mL IM injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males or females aged 18 years and above at the time of consent.
- Participants who provide a voluntarily consent to participate in the study and sign the consent form.
- Participants who have previously received homologous 2-dose of SARS-COV-2 Vaccine (either Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARS-COV-2 Vaccine, or Cominarty/Pfizer mRNA COVID-19 Vaccine) authorized for emergency use, between 6 to 12 months post second prime vaccine dose prior to Day 1.
- Participants who have negative results for swab SARS-COV-2 rapid antigen test.
Key exclusion criteria (15 listed)
- Participants who are unable to follow clinical and follow-up procedures.
- Participants with acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the dosing.
- Participants with a history of PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing.
- Female who are pregnant or breastfeeding.
- Participants with a history of hypersensitivity or allergic reactions including anaphylaxis.
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 |
|---|---|---|
| SARS-COV-2 Vaccine (Vero Cell-Sinopharm) InactivatedSARS-CoV-2 vaccine (Vero cell) inactivated developed by Beijing Bio-Institute Biological Products Co., Ltd, can induce active immunity and prevent diseases caused by the SARS-CoV-2 virus by producing neutralizing antibody. The inactivated SARSCoV-2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying and adding aluminum hydroxide adjuvant. | Biological | SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated |
Primary outcome
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
Time frame: Within 28 days after one booster dose
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days
Time frame: Within 28 days after one booster dose
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
Time frame: Within 28 days after one booster dose
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 14 and 28 days
Time frame: Within 28 days after one booster dose
To evaluate the immunogenicity at 14 and 28 days after one booster dose of 0.5 mL intramuscular (IM) injection of SARS-COV-2 Vaccine (Vero Cell) Inactivated compared to placebo in participants who had received second dose of SARS-CoV-2 prime vaccine at least 6 months
8 secondary outcomes
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
Time frame: At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at 90, 180, and 360 days
Time frame: At 90, 180, and 360 days after one booster
The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
Time frame: At 90, 180, and 360 days after one booster
The geometric mean fold rise (GMFR) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody at 90, 180, and 360 days
Time frame: At 90, 180, and 360 days after one booster
To proportion of solicited adverse events within 7 days after one booster dose
Time frame: Within 7 days after one booster
To proportion of unsolicited adverse events within 28 days after one booster dose
Time frame: Within 28 days after one booster
To proportion of clinically significant abnormal liver function (AST, ALT, Total Bilirubin) at 14 days and 28 days
Time frame: Within 28 days after one booster
To proportion of serious adverse events within 180 days after one booster dose
Time frame: Within 180 days after one booster
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Jarir At Thobari contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SARS-COV-2 Vaccine (Vero Cell-Sinopharm) Inactivated in people with COVID-19, run by PT. Kimia Farma (Persero) Tbk at 7 sites 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 15 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prenali Dwisthi Sattwika (+62 274-560-455, boost.vctrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The geometric mean titer (GMT) of anti-SARS-CoV-2 neutralizing antibody at 14 and 28 days (time frame: Within 28 days after one booster dose). The study lists 4 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 8 Sep 2022.