Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly

NCT05283902 | Completed DMC

• 1 other identifier: FUES05
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational case-crossover study is to evaluate the effectiveness, safety and immunogenicity of the second booster dose in the elderly. There are an estimated 490,000 eligible individuals aged 60 and over statewide for the effectiveness study. Two hundred and sixty participants will be invited to participate in biological sample for the immunogenicity study. This sub-sample will be compared with 260 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. The main effectiveness outcome will be the number of hospitalizations; and secondary outcomes will be deaths, number of reported cases, number of cases confirmed by RT-PCR. The safety assessment will be carried out by monitoring adverse events. The cellular and humoral immune response will be evaluated by viral neutralization assay (search for neutralizing antibodies), serological assay by chemiluminescence, determination of specific IgM and IgG profile, dosage of soluble systemic factors (chemokines, cytokines and growth factors), stimulation in vitro antigen-specific peripheral blood mononuclear cells and investigation of memory T and B lymphocytes and intracytoplasmic cytokines. The study hypothesis is that elderly people who received the second booster dose have a lower incidence rate of hospitalizations and death than those who received the primary regimen (two doses or one of Janssen) or a booster dose, and that the immune response humoral and cellular function of the elderly is similar to those who are immunosuppressed.

Conditions

COVID-19; Vaccine Adverse Reaction; Vaccine-Preventable Diseases

Outcome Measures

Primary Outcomes (2)

• number of hospital admissions

  number of hospital admissions for covid-19 recorded in the "e-SUS notifica"

  Change from baseline at 6 months

• Number of adverse events

  Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) recorded in the "e-SUS notifica"

  Change from baseline at 1 month

Secondary Outcomes (7)

• number of deaths

  Change from baseline at 6 months

• number of Covid-19 cases

  Change from baseline at 6 monhts

• Viral neutralization assay

  Change from baseline at 1, 3, 5 and 6 months

• Serological assay

  Change from baseline at 1, 3, 5 and 6 months

• Soluble systemic factors

  Change from baseline at 1, 3, 5 and 6 months

Study Arms (1)

Elderly group - Immunogenicity

260 participants from the Effectiveness group, 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.

Biological: ChAdOx1 nCoV-19 or Comirnaty or Janssen COVID-19 Vaccine

Interventions

ChAdOx1 nCoV-19 or Comirnaty or Janssen COVID-19 Vaccine BIOLOGICAL

In a Technical Note, the State of Espírito Santo decided to recommend the application of the fourth dose with vaccines using messenger RNA (mRNA) technology or viral vector vaccine, for all people aged 60 years or older, with an interval of 90 days from of the third dose, considering that, while there is no availability of vaccines adapted to the new variants, boosters with available vaccines are still the most appropriate ways to prevent hospitalization and deaths.

Elderly group - Immunogenicity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age equal to or greater than 60 years
• Residents of Espírito Santo, Brazil

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Espirito Santo: lead
• Secretaria de Estado da Saúde do Espírito Santo - SESA: collaborator
• Centro de Pesquisas René Rachou: collaborator

Study Sites (1)

Valéria Valim

Vitória, Espírito Santo, 29041-295, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (cellular and humoral immune response)

MeSH Terms

Conditions

COVID-19; Vaccine-Preventable Diseases

Interventions

ChAdOx1 nCoV-19; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; mRNA Vaccines; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 17, 2022
• Study Start: March 19, 2022
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)