Study of the Effectiveness of The COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:

Study of the Effectiveness of The COVID-19 Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05766176
• Other study ID #: NAP04
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Universitas Sebelas Maret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Universitas Sebelas Maret Hospital	Sukoharjo	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View Citation

Sholihah 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of quantitative anti-sars-cov-2 titers before the second booster of vaccination COVID-19 and one month after