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AzTrials

COVID-19 VaccinesWORLDCOVNCT05471635

Variables Influencing Anti-COVID-19 Vaccinations Around the World: an Analysis Conducted on Aggregated Data Sourced From Institutional Databases to Understand Whether and How Different Variables Could Affect the Vaccine Coverage (WORLDCOV: Worldwide Determinants of COVID-19 Vaccination)

An observational study of COVID-19 Vaccines, run by Alberto Peano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Vaccination coverage against COVID-19 differs widely between countries: in order to address this public health issue, this observational study seeks to understand whether there are any determinants/predictors. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccines
What is being tested?
COVID-19 Vaccine
Type of treatment
Vaccines
How many people
205 participants
Where
1 siteItaly
Study dates
20 Jun 2022to 20 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: All countries worldwide, if not excluded in reason of Exclusion Criteria

Who may be able to join

  • All countries (independent or not) in the world

Who cannot join

  • No data available on vaccination coverage and dose administered population ratio
  • Substantial lack of data

Trial locations and contacts

1 site in 1 country.

Alberto Peano, Dr. contact

+39 3923983663

alberto.peano@unito.it

Italy1 site, 1 recruiting
  • University of Turin

    Turin, 10126

    Alberto Peano, Dr., +39 3923983663, alberto.peano@unito.it

    Recruiting

Other trials in Italy

About this study

Official title: Determinants of COVID-19 Vaccination Worldwide: WORLDCOV, a Retrospective Observational Study

Vaccination coverage against COVID-19 differs widely between countries: in order to address this public health issue, this observational study seeks to understand whether there are any determinants/predictors. In order to highlight the presence of determinants and their strength in influencing vaccination coverage, all possible socio-demographic, economic, cultural, infrastructural and political variables considered capable of modifying such coverage were selected and analysed.

Read the detailed description

The COVID-19 pandemic has had major health, economic and social implications, bringing with it a large number of deaths worldwide. While the lethality rate could not be considered high, the fact that the contagiousness was high resulted in a considerable number of deaths. As a result, the COVID-19 pandemic has become a sudden, huge and urgent public health problem.

Initially faced with a new and unknown etiopathological entity, different countries adopted different policies that proved more or less effective in containing the COVID-19 contagion. While social and hygienic restrictive measures (i.e. so-called social distancing, curfews, use of masks and hand hygiene) initially had a positive impact on reducing infections, for the most part they proved to be ephemeral measures. These actions were short-lived because they were not sustainable over time due to the damage they implied with regard to mental health, besides the low adherence of the population. A relaxation of these restrictive measures has always led to an increase in the spread of the COVID-19 pandemic, with a resurgence of hospital admissions, an ever-increasing occupancy of intensive care beds and a subsequent increase in the number of deaths.

Since the beginning of the COVID-19 pandemic, scientific research has been working to enable the identification of the SARS-CoV-2 viral genome and possible target proteins for treatment. Due to years of vaccine research and the launch of Access to COVID-19 Tools (ACT)-Accelerator partnership, a rapid development of several candidate vaccines based on different vaccine technologies and thus to their rapid clinical testing were possible.

Thanks also to the regulatory agencies' solicitude, in certain Countries (e.g. Israel, the UK, the US and the EU) the COVID-19 vaccination campaign started at the end of 2020 and extended worldwide during 2021 (with the exception of Eritrea and the Democratic Republic of Korea).

Through purchasing agreements with individual vaccine manufacturers, governments (or supranational institutions, e.g. the EU) secured the supply of the necessary doses. However, this entailed a division of the world's population depending on the negotiating power of the country of residence and, therefore, its economic strength. COVAX is one of the three pillars of the ACT-Accelerator programme: dedicated to vaccines, the purpose of COVAX is to accelerate the development and manufacture of COVID-19 vaccines, ensuring fair and equitable access for every country in the world.

In a globalised world, guaranteeing everyone the right to health is mandatory from a moral as well as an economic and global health point of view: everyone gains if the poorest improve their condition (think infectious diseases). In a globalised world, it is necessary to 'globalise' health and not only the economy: this study aims to understand where governments, supranational institutions and non-governmental organisations can act more incisively to combat the COVID-19 pandemic with the weapon the vaccine represents.

On this basis, the investigators decided to examine whether certain variables could be determinants of vaccination coverage for COVID-19. Two outcomes were identified as indicators of vaccination coverage: the proportion of the population vaccinated with at least one dose and the ratio of administered doses to the population. These data were obtained from the COVID-19 dataset by Our World In Data as of 15th June for each country. If data was not available on that date, the most recent available data was used looking retrospectively. In order to analyze whether and which were determinants of vaccination coverage, several variables are accounted: socio-demographic variables: total population, population density, median age, GINI Index; economic variables: GDP per capita; health variables: COVID-19-specific mortality, type of health system (public or private), health personnel (Physicians /1000 population, Nurses and midwives personnel/1000 population); cultural variables (literacy rate, Greenberg Index, presence of a predominant religion), infrastructural variables (density of road network, access to electricity) and political variables (civil liberties, political stability and absence of violence/terrorism). Data for the aforementioned variables were extracted from institutional databases/ datasets: World Bank, Our World In Data, World Religion Database and The World Factbook. For Greenberg Index, as proxy of Cultural Diversity Index, the data were from Gören (2018), taking the 2020 figure for each country, or the most recent available figure if the 2020 figure is not available.

Statistical analyses will be conducted including all countries in the world taken individually, for which vaccination data are available as of 15 June 2022. In addition, analyses will also be conducted for outcomes adjusted for vaccine doses delivered (in each country). The data for this correction factor were obtained from the UNICEF database on 21th June 2022.

Statistical analyses by subgroups will also be implemented, stratifying by World Bank country classification by income level: High, Upper-middle, Lower-middle, Low.

Being tested
COVID-19 Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 VaccineBiological

    All COVID-19 vaccines approved by national or international regulatory agency, despite the vaccine technology, manufacturer, and regulatory agency that granted marketing authorization.

Study groups in NCT05471635
Study groupRoleWhat they receive
Countries worldwideEvery country in the world for which vaccination data were available and variables of interest were accessible.
Receives: Biological: COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccination coverage

    Proportion of the population vaccinated with at least one dose

    Measured: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign

  2. Total doses administered per 100 residents

    Doses of vaccine administered per 100 population in each country, that is the ratio of administered doses to the population

    Measured: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start20 Jun 2022
  3. Primary completion20 Jul 2022 (estimated)
  4. Study completion20 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Retrospective
Enrolment
205 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05471635
Sponsor's protocol ID
GP0012022
Acronym
WORLDCOV
Status last verified
Jul 2022
First submitted
20 Jul 2022
Last updated
27 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peano A, Politano G, Gianino MM. Determinants of COVID-19 vaccination worldwide: WORLDCOV, a retrospective observational study. Front Public Health. 2023 Aug 31;11:1128612. doi: 10.3389/fpubh.2023.1128612. eCollection 2023.

    PubMed 37719735

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Vaccines, run by Alberto Peano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alberto Peano, Dr. (+39 3923983663, alberto.peano@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccination coverage (time frame: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05471635, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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