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NCT05479383 Clinical Trial

Tobacco Use and Uptake of COVID-19 Vaccinations

COVID-19 Clinical Trial

Official title:
Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: a General Population Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05479383
Other study ID # THL/713/6.00.00/2021.2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2, 2017
Est. completion date June 2023

Study information
Verified date May 2023
Source Finnish Institute for Health and Welfare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.

Description:

Most high income countries have rolled out COVID-19 vaccinations, with the promise of reducing incident COVID-19 infections and preventing hospitalizations and deaths. A high vaccination coverage is crucial for several reasons: (i) to reduce the number of new COVID-19 cases, (ii) to diminish selective pressures leading to the emergence of new variants of concern, (iii) to prevent severe COVID-19 outcomes, such as hospitalizations and deaths, and (iv) to potentially reduce the risk of post-acute COVID-19 symptoms. Smokers are at higher risk of COVID-19 hospitalizations and deaths and might thus benefit greatly from high vaccination coverage. However, evidence suggests that they may be less likely to be vaccinated, as smokers are less likely to adhere to preventive measures in general and have lower adherence to other vaccines. Reports of a protective role of smoking on the risk of COVID-19 infection might have also reduced the perceived risks from being infected. Evidence regarding tobacco use and COVID-19 vaccine hesitancy is mixed. Some studies have shown greater mistrust in COVID-19 vaccine benefits and greater vaccine hesitancy and lower vaccine acceptance compared to non-smokers, while other studies have reported no differences by smoking status or lower levels of vaccine hesitancy in smokers compared to non-smokers. Few studies have examined the relationship between tobacco use and vaccine uptake, showing that smokers had higher odds of being vaccinated. These studies, however, are not representative of the general population and relied on self-reported vaccination status, resulting in higher risk of selection and information bias. The investigators will expand current knowledge by examining two forms of tobacco use in Finland -smoking and smokeless tobacco use (snus)- and by analysing the spacing between vaccine doses. The study will use data from nationally representative surveys in Finland linked to vaccination registries, which reduces the risk of selection and information bias.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 42935
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Permanent residents of Finland - Registered in the Population Register at the moment of sampling - Aged 20 and over - Participated in the FinSote surveys in 2018 or 2020 - Provided consent for register linkage Exclusion Criteria: - Temporary residents in Finland or tourists - Age less than 20 years old - Did not participate in FinSote surveys in 2018, 2019 and 2020 - Did not provide consent for register linkage

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Not applicable, this is an observational study
Not applicable, this is an observational study

Locations
Country Name City State
Finland Finnish Institute for Health and Welfare Helsinki Uusimaa

Sponsors (3)
Lead Sponsor Collaborator
Finnish Institute for Health and Welfare Karolinska Institutet, Norwegian Institute of Public Health

Country where clinical trial is conducted

Finland, 

References & Publications (12)

Ali M, Ahmed S, Bonna AS, Sarkar AS, Islam MA, Urmi TA, Proma TS. Parental coronavirus disease vaccine hesitancy for children in Bangladesh: a cross-sectional study. F1000Res. 2022 Jan 25;11:90. doi: 10.12688/f1000research.76181.2. eCollection 2022. — View Citation

Ishimaru T, Okawara M, Ando H, Hino A, Nagata T, Tateishi S, Tsuji M, Matsuda S, Fujino Y; CORoNaWork Project. Gender differences in the determinants of willingness to get the COVID-19 vaccine among the working-age population in Japan. Hum Vaccin Immunother. 2021 Nov 2;17(11):3975-3981. doi: 10.1080/21645515.2021.1947098. Epub 2021 Jul 2. — View Citation

Jackson SE, Paul E, Brown J, Steptoe A, Fancourt D. Negative Vaccine Attitudes and Intentions to Vaccinate Against Covid-19 in Relation to Smoking Status: A Population Survey of UK Adults. Nicotine Tob Res. 2021 Aug 18;23(9):1623-1628. doi: 10.1093/ntr/ntab039. — View Citation

Ko T, Dendle C, Woolley I, Morand E, Antony A. SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. Hum Vaccin Immunother. 2021 Nov 2;17(11):4048-4056. doi: 10.1080/21645515.2021.1958611. Epub 2021 Aug 6. — View Citation

Krebs NM, D'Souza G, Bordner C, Allen SI, Hobkirk AL, Foulds J, Yingst JM. COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users. Tob Use Insights. 2021 Dec 20;14:1179173X211068027. doi: 10.1177/1179173X211068027. eCollection 2021. — View Citation

Luk TT, Zhao S, Wu Y, Wong JY, Wang MP, Lam TH. Prevalence and determinants of SARS-CoV-2 vaccine hesitancy in Hong Kong: A population-based survey. Vaccine. 2021 Jun 16;39(27):3602-3607. doi: 10.1016/j.vaccine.2021.05.036. Epub 2021 May 18. — View Citation

Oruc MA, Ozturk O. Attitudes of health care professionals towards COVID-19 vaccine - a sequence from Turkey. Hum Vaccin Immunother. 2021 Oct 3;17(10):3377-3383. doi: 10.1080/21645515.2021.1928462. Epub 2021 Jun 18. — View Citation

Simons D, Shahab L, Brown J, Perski O. The association of smoking status with SARS-CoV-2 infection, hospitalization and mortality from COVID-19: a living rapid evidence review with Bayesian meta-analyses (version 7). Addiction. 2021 Jun;116(6):1319-1368. doi: 10.1111/add.15276. Epub 2020 Nov 17. — View Citation

Tan LF, Huak CY, Siow I, Tan AJ, Venugopalan PM, Premkumar A, Seetharaman SK, Tan BYQ. The road to achieving herd immunity: factors associated with Singapore residents' uptake and hesitancy of the COVID-19 vaccination. Expert Rev Vaccines. 2022 Apr;21(4):561-567. doi: 10.1080/14760584.2022.2021883. Epub 2022 Jan 11. — View Citation

Tiirinki H, Viita-Aho M, Tynkkynen LK, Sovala M, Jormanainen V, Keskimaki I. COVID-19 in Finland: Vaccination strategy as part of the wider governing of the pandemic. Health Policy Technol. 2022 Jun;11(2):100631. doi: 10.1016/j.hlpt.2022.100631. Epub 2022 Apr 14. — View Citation

Wisniak A, Baysson H, Pullen N, Nehme M, Pennacchio F, Zaballa ME, Guessous I, Stringhini S; Specchio-COVID19 study group. COVID-19 vaccination acceptance in the canton of Geneva: a cross-sectional population-based study. Swiss Med Wkly. 2021 Dec 14;151:w30080. doi: 10.4414/smw.2021.w30080. eCollection 2021 Dec 6. — View Citation

Wu J, Li Q, Silver Tarimo C, Wang M, Gu J, Wei W, Ma M, Zhao L, Mu Z, Miao Y. COVID-19 Vaccine Hesitancy Among Chinese Population: A Large-Scale National Study. Front Immunol. 2021 Nov 29;12:781161. doi: 10.3389/fimmu.2021.781161. eCollection 2021. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Vaccination uptake of at least two doses of a COVID-19 vaccine Proportion of participants with at least two doses of a COVID-19 vaccine Baseline until date of vaccination or May 31, 2022
Secondary Vaccination uptake of at least one dose of a COVID-19 vaccine Proportion of participants with at least one dose of a COVID-19 vaccine Baseline until date of vaccination or May 31, 2022
Secondary Vaccination uptake of complete COVID-19 vaccination scheme (two doses and a booster dose) Proportion of participants with two doses and a booster dose of a COVID-19 vaccine Baseline until date of vaccination or May 31, 2022
Secondary Spacing of first and second COVID-19 dose Proportion of participants with more than 7 months between the first and second COVID-19 dose Baseline until date of vaccination or May 31, 2022
Secondary Spacing of second dose and booster dose of the COVID-19 vaccine Proportion of participants with more than 7 months between the second dose and booster dose of the COVID-19 vaccine Baseline until date of vaccination or May 31, 2022
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