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Fourth COVID shot may shield seniors from severe illness

NCT ID NCT05283902

Disease control Sponsor: Federal University of Espirito Santo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study in Brazil looked at whether a fourth dose of a COVID-19 vaccine helps protect people aged 60 and older from hospitalization and death. Researchers tracked 260 elderly participants who received a second booster and compared their immune responses to samples from immunosuppressed patients. The goal was to see if the extra dose lowers severe outcomes and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COVID-19 vaccine (ChAdOx1 nCoV-19, Comirnaty, or Janssen)
What this could lead to
If successful, this could show that a fourth dose offers extra protection against severe COVID-19 in older adults, helping guide booster recommendations.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The sample for immune testing is small (260 people), and findings may not apply to other regions or variants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

260 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

There are an estimated 490,000 eligible individuals aged 60 and over statewide for the effectiveness study. Two hundred and sixty participants, with quotas distributed by sex (50% male and 50% female) and age group, will be invited to participate in biological sample collection for the immunogenicity study, in a health unit in Cariacica-ES. This sub-sample will be compared with 240 biorepository samples from a cohort of immunosuppressed patients with autoimmune diseases who received the fourth dose, in a study conducted by the same team of researchers.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age equal to or greater than 60 years * Residents of Espírito Santo, Brazil Exclusion Criteria: * Being under active treatment (chemotherapy and/or radiotherapy) for the treatment of any type of neoplasm * Being admitted to an institutionalization establishment for the elderly (hospitals, nursing homes, shelters or similar). * Patients with mental illness with inability to understand the consent form

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Conditions

The condition(s) this trial relates to.

Vaccine-Preventable Diseases COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19 Vaccine adverse reaction Vaccine-preventable diseases

Contacts and locations

Locations

  • Valéria Valim

    Vitória, Espírito Santo, 29041-295, Brazil

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