Adverse Events Report of Inactivated COVID-19 Vaccine

• ClinicalTrials.gov Identifier: NCT05026879
• Recruitment Status: Completed
• First Posted: August 30, 2021
• Last Update Posted: September 2, 2021
• Sponsor: Bozyaka Training and Research Hospital
• Information provided by (Responsible Party): Şeniz Akçay, Bozyaka Training and Research Hospital

Tracking Information

• First Submitted Date: August 27, 2021
• First Posted Date: August 30, 2021
• Last Update Posted Date: September 2, 2021
• Actual Study Start Date: February 14, 2021
• Actual Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2021)

Adverse events detection [ Time Frame: 20 minutes ]

An online questionnaire was delivered to obtain Vaccine Adverse Effects to volunteer Healthcare Workers in Turkey.

Original Primary Outcome Measures (submitted: August 27, 2021)

Adverse events detection [ Time Frame: 20 minutes ]

An online questionnaire was delivered to obtain VAEs to volunteer HCWs in Turkey.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adverse Events Report of Inactivated COVID-19 Vaccine
• Official Title: Adverse Events Report of Inactivated COVID-19 Vaccine From 4040 Healthcare Workers

Brief Summary

Numerous vaccination studies are conducted to protect against COVID-19 infection, and preclinical and clinical studies are still ongoing worldwide. During this extraordinary period, the necessity to perform COVID-19 vaccine studies and immunization programs together has emerged. Many manufacturing companies have started mass production of vaccines accepting the risk of failure of vaccines during trials. Vaccine Adverse Effects (VAEs) need to be documented quickly. We aimed to determine the VAEs and to compare the frequency of VAEs between groups according to socio-demographic characteristics after the inactivated vaccine (Corona Vac®) was administered to healthcare workers (HCWs) in Turkey.

In this study, an online questionnaire was delivered to volunteer healthcare workers across the whole country. Sociodemographic characteristics, medical history, history of COVID-19 infection, and VAEs occurring after the first and second doses of inactivated vaccine were evaluated.

Detailed Description

A new coronavirus, severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) first appeared in China at the end of 2019 and attracted attention with clusters of pneumonia-like cases, which were later defined as coronavirus disease 2019 (COVID-19). Vaccine development is usually achieved over decades and therefore it is unprecedented to have access to such a large number of approved vaccines for COVID-19. In this process, great efforts were made by many organizations to cope with this pandemic that affected the whole world.

COVID-19 vaccines with different features in the form of vector-mediated, messenger RNA (mRNA) or inactivated vaccines are being produced worldwide. CoronaVac® is an inactivated vaccine against severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) developed by Sinovac Biotech, China which was approved by World Health Organization (WHO) in June 2021.

Vaccine Adverse Effect (VAE) is defined as "any adverse medical event that occurs after vaccination, which is thought to be due to a vaccine.

The primary endpoint of our study was to evaluate the VAEs reported after the first dose and the second doses following the inactivated vaccine (CoronaVac®), which was administered to HCWs in our country as a dose of 3 µg twice, 28 days apart. The secondary endpoint was the comparison of the frequency of VAE development between groups according to socio-demographic characteristics.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The healthcare workers

Condition

• COVID-19
• Vaccine Adverse Reaction

Intervention

Biological: Inactivated COVID-19 vaccine (CoronaVac)

The adverse events due to an inactivated COVID-19 vaccine.

• Study Groups/Cohorts: Not Provided

Publications *

• Li J, Huang DQ, Zou B, Yang H, Hui WZ, Rui F, Yee NTS, Liu C, Nerurkar SN, Kai JCY, Teng MLP, Li X, Zeng H, Borghi JA, Henry L, Cheung R, Nguyen MH. Epidemiology of COVID-19: A systematic review and meta-analysis of clinical characteristics, risk factors, and outcomes. J Med Virol. 2021 Mar;93(3):1449-1458. doi: 10.1002/jmv.26424. Epub 2020 Aug 25.
• Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
• Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543.
• Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703.
• Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, Huang W, Xu W, Huang B, Wang H, Wang W, Zhang W, Li N, Xie Z, Ding L, You W, Zhao Y, Yang X, Liu Y, Wang Q, Huang L, Yang Y, Xu G, Luo B, Wang W, Liu P, Guo W, Yang X. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. doi: 10.1016/S1473-3099(20)30831-8. Epub 2020 Oct 15.
• Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.
• Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 27, 2021): 4040
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 14, 2021
• Actual Primary Completion Date: February 28, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1)The HCWs vaccinated with two doses of CoronaVac.

Exclusion Criteria:

1. The HCWs under 18 years old
2. The HCWs those couldn't be able to complete the questionnaire accurately.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT05026879
• Other Study ID Numbers: 24.02.2021-29
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Şeniz Akçay, Bozyaka Training and Research Hospital
• Original Responsible Party: Şeniz Akçay, Bozyaka Training and Research Hospital, Assoc. Prof. Seniz Akcay
• Current Study Sponsor: Bozyaka Training and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Selma Tosun, Prof.; Izmir Bozyaka Education and Research Hospital
• Study Chair: Hulya Ozkan Ozdemir, MD; Izmir Bozyaka Education and Research Hospital
• Study Chair: Esin Erdogan, Assoc. Prof.; University of Health Sciences, Izmir Bozyaka Education and Research Hospital
• Study Chair: Seniz Akcay, Assoc. Prof.; University of Health Sciences, Izmir Bozyaka Education and Research Hospital
• Study Chair: Murat Aysin, Assis. Prof.; Izmir Katip Celebi University, Faculty of Medicine
• Study Chair: Neslihan Eskut, MD; University of Health Sciences, Izmir Bozyaka Education and Research Hospital
• Study Chair: Pinar Ortan, Prof.; University of Health Sciences, Izmir Bozyaka Education and Research Hospital
• Study Chair: Burak Eskut, MD; University of Izmir Katip Celebi, Ataturk Education and Research Hospital

• PRS Account: Bozyaka Training and Research Hospital
• Verification Date: August 2021