COVID-19NCT05766176
Study of the Effectiveness of The COVID-19 Vaccine
An observational study of COVID-19, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This descriptive study examines neutralizing antibody levels against COVID-19 in health workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 Antibody
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2022to 30 Nov 2022
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Health worker in Universitas Sebelas Maret Hospital, Surakarta, Indonesia
Who may be able to join
- Health workers who receive the second booster of COVID-19 vaccination
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
About this study
This descriptive study examines neutralizing antibody levels against COVID-19 in health workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia.
Read the detailed description
This research is a cross-sectional study with a descriptive-analytic design, community-based, of adults who live in Surakarta (age 18 years and over) using the Google form. The inclusion criteria were health workers receiving the third or second dose of the COVID-19 vaccine. Quantitative antibody titers are checked at Prodia's laboratory. Other variables examined were the number and date of vaccination, age, sex, comorbid diseases, body mass index, AEFI symptoms after the vaccine, and history of being infected with COVID-19. In the statistical analysis using the different and regression correlation tests, the significance level of P is less than 0.05.
- Conditions
- COVID-19
- Being tested
- COVID-19 Antibody
- Keywords
- COVID-19 Vaccine, Health Worker
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 AntibodyDiagnostic test
Also called COVID-19 Immunoglobulin
This descriptive study examines the levels of neutralizing antibodies against COVID-19 in health workers before and after the Quantitative Anti-SARS-CoV-2 Test is an examination to measure in vitro quantitative antibodies (including IgG) against the receptor binding domain (RBD) of the SARS-CoV Spike (S) protein. -2, which aims to assess the adaptive humoral immune response to the SARS-CoV-2 Spike protein. Measurement with the ECLIA method. Ratio Scale after the 2nd booster COVID-19 vaccine in Surakarta, Indonesia.
| Study group | Role | What they receive |
|---|---|---|
| Health worker | A health worker who received a second dose of booster COVID19 vaccine Receives: Diagnostic Test: COVID-19 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative anti-sars-cov-2 titers
The quantitative Anti-SARS-CoV-2 test is an examination to measure in vitro quantitative antibodies (including IgG) against the receptor binding domain (RBD) of the SARS-CoV-2 Spike protein (S) which aims to assess the adaptive humoral immune response to the SARS-CoV-2 Spike protein. Measurement with the ECLIA method. Ratio Scale
Measured: Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Jul 2022
- Primary completion30 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
- Investigators
- Nurhasan Agung Prabowo, MD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766176
- Sponsor's protocol ID
- NAP04
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
PubMed 34912736Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
PubMed 34181079
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of The COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05766176
- Acronym / sponsor ID
- NAP04
- Conditions
- COVID-19
- Keywords
- COVID-19 Vaccine, Health Worker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Mar 2023 (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 descriptive study examines neutralizing antibody levels against COVID-19 in health workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia.
Detailed description
This research is a cross-sectional study with a descriptive-analytic design, community-based, of adults who live in Surakarta (age 18 years and over) using the Google form. The inclusion criteria were health workers receiving the third or second dose of the COVID-19 vaccine. Quantitative antibody titers are checked at Prodia's laboratory. Other variables examined were the number and date of vaccination, age, sex, comorbid diseases, body mass index, AEFI symptoms after the vaccine, and history of being infected with COVID-19. In the statistical analysis using the different and regression correlation tests, the significance level of P is less than 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health worker | – | Diagnostic Test: COVID-19 AntibodyA health worker who received a second dose of booster COVID19 vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health worker in Universitas Sebelas Maret Hospital, Surakarta, Indonesia
Key inclusion criteria (1 listed)
- Health workers who receive the second booster of COVID-19 vaccination
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| COVID-19 AntibodyAlso: COVID-19 ImmunoglobulinThis descriptive study examines the levels of neutralizing antibodies against COVID-19 in health workers before and after the Quantitative Anti-SARS-CoV-2 Test is an examination to measure in vitro quantitative antibodies (including IgG) against the receptor binding domain (RBD) of the SARS-CoV Spike (S) protein. -2, which aims to assess the adaptive humoral immune response to the SARS-CoV-2 Spike protein. Measurement with the ECLIA method. Ratio Scale after the 2nd booster COVID-19 vaccine in Surakarta, Indonesia. | Diagnostic test | Health worker |
Primary outcome
quantitative anti-sars-cov-2 titers
Time frame: Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after
The quantitative Anti-SARS-CoV-2 test is an examination to measure in vitro quantitative antibodies (including IgG) against the receptor binding domain (RBD) of the SARS-CoV-2 Spike protein (S) which aims to assess the adaptive humoral immune response to the SARS-CoV-2 Spike protein. Measurement with the ECLIA method. Ratio Scale
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 13 Mar 2023.
- Results publication: PubMed 34912736Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
- Results publication: PubMed 34181079Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
- 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.
Nurhasan Agung Prabowo, MD principal investigator
Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universitas Sebelas Maret 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 1 inclusion and 1 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 13 Mar 2023. 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.
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?
quantitative anti-sars-cov-2 titers (time frame: Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766176, which also lists 2 linked publications.
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 13 Mar 2023.