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Study of the Effectiveness of The COVID-19 Vaccine

Sponsor
Universitas Sebelas Maret (Other)
Overall Status
Completed
CT.gov ID
NCT05766176
Collaborator
(none)
100
Enrollment
1
Location
5
Actual Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: COVID-19 Antibody

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

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Study of the Effectiveness of The COVID-19 Vaccine
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Oct 30, 2022
Actual Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. quantitative anti-sars-cov-2 titers [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Health workers who receive the second booster of COVID-19 vaccination
    Exclusion Criteria:
    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitas Sebelas Maret Hospital Sukoharjo Central Java Indonesia 57161

    Sponsors and Collaborators

    • Universitas Sebelas Maret

    Investigators

    • Principal Investigator: Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nurhasan Agung Prabowo, Head of Hospital Research Unit, Universitas Sebelas Maret
    ClinicalTrials.gov Identifier:
    NCT05766176
    Other Study ID Numbers:
    • NAP04
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nurhasan Agung Prabowo, Head of Hospital Research Unit, Universitas Sebelas Maret
    COVID-19 Vaccine, Health Worker
    Additional relevant MeSH terms:
    COVID-19
    Antibodies
    Immunoglobulins

    Study Results

    No Results Posted as of Mar 13, 2023