Study of the Effectiveness of The COVID-19 Vaccine

March 9, 2023 updated by: Nurhasan Agung Prabowo, Universitas Sebelas Maret
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Sukoharjo, Central Java, Indonesia, 57161
        • Universitas Sebelas Maret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Health worker in Universitas Sebelas Maret Hospital, Surakarta, Indonesia

Description

Inclusion Criteria:

  • Health workers who receive the second booster of COVID-19 vaccination

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Health worker
A health worker who received a second dose of booster COVID19 vaccine
Diagnostic test: COVID-19 Antibody
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.
Other Names:
  • COVID-19 Immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAP04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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