EFFECTIVENESS, SAFETY AND IMMUNOGENICITY OF THE HALF DOSE OF THE VACCINE ChadOx1 nCoV-19 (AZD1222) for COVID-19

NCT05059106 | Unknown Phase 2 DMC

• 1 other identifier: FUES02
• Study Type: interventional
• Target: 29,637
• Locations: 1 country
• Sites: 1

Brief Summary

This study is clinical trial (intervention study with external comparison group) to test vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years from Viana city - Espírito Santo (ES)/Brazil, on the incidence of new cases over 12 months following treatment, compared to an external group from same state and adjusted for socio-demographic and epidemiological variables.

Conditions

SARS-CoV-2

Keywords

vaccines; immunity; covid-19

Outcome Measures

Primary Outcomes (1)

• Incidence of new cases

  Incidence of new cases over 12 months following treatment

  12 months

Secondary Outcomes (12)

• Number of deaths

  12 months

• number of hospital admissions

  12 months

• number of intensive care unit (ICU) admissions

  12 months

• number of tests (RT-PCR)

  12 months

• Viral Neutralization Assay

  4 and 8 months

Other Outcomes (1)

• Adverse events

  14 months

Study Arms (2)

Group 1

EXPERIMENTAL

Half dose of ChAdOx1 nCoV-19 (AZD1222) ) in a 2-dose schedule with an interval of 8 weeks.

Biological: Half dose of ChAdOx1 nCoV-19 (AZD1222)

Group 2

ACTIVE COMPARATOR

Standad dose of ChAdOx1 nCoV-19 (AZD1222) in a 2-dose schedule with an interval of 8 weeks.

Biological: Standard dose of ChAdOx1 nCoV-19 (AZD1222)

Interventions

Half dose of ChAdOx1 nCoV-19 (AZD1222) BIOLOGICAL

Vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years, from non-priority groups, from Viana city - Espírito Santo (ES)/Brazil.

Group 1

Standard dose of ChAdOx1 nCoV-19 (AZD1222) BIOLOGICAL

Vaccination with standad dose of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, in external cohort of health workers aged 18 to 49 years.

Group 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- residents of Viana, Espírito Santo, aged between 18 and 49 years

You may not qualify if:

• Pregnant women;
• History of severe allergic reaction (anaphylaxis) to any previously administered vaccine;
• Having received another vaccine in the last 14 days;
• Belonging to a priority risk group for vaccination, as per the PNI recommendations;
• Have fever or flu-like symptoms;
• Have previously received any vaccine for covid-19 at any time;
• Recent diagnosis of covid-19 with onset of symptoms 28 days before vaccination;
• Disorders of coagulation and use of anticoagulants.

Sponsors & Collaborators

• Federal University of Espirito Santo: lead
• Centro de Pesquisas René Rachou: collaborator
• Escola Nacional de Saúde Pública Sérgio Arouca/Fiocruz: collaborator
• Oswaldo Cruz Foundation: collaborator
• Escola Superior de Ciências da Santa Casa de Misericórdia de Vitória: collaborator

Study Sites (1)

Federal University of Espirito Santo

Vitória, Espírito Santo, 29041-295, Brazil

RECRUITING

Related Publications (1)

• Medeiros-Junior NF, Gouvea MDPG, Camacho LAB, Villela DAM, Lima SMB, Schwarcz WD, Azevedo AS, Neto LFP, Domingues CMAS, Fantoni RNDS, Forechi L, Ruchdeschel T, Albertino LF, Pereira M, Rizzi RB, Muniz SM, Santos HCD, de Oliveira Roza TL, Oliveira YGP, Dias LH, Miyamoto ST, Tapia KRL, Lyra DGP, Jubini JD, Burian APN, Moulaz IR, Araujo MF, Tort LFL, Oliveira ACA, Oliveira Prado R, Pereira AAS, Miranda VHS, Speziali E, Costa-Pereira C, Alves CC, Carvalho KRA, Dos Santos LM, Oliveira-Carvalho N, Oliveira G, Santos TMAFD, Figueiredo ACC, Costa-Rocha IA, Campi-Azevedo AC, Peruhype-Magalhaes V, Garcia CC, Siqueira MM, Antonelli LRDV, Coelho-Dos-Reis JGA, Teixeira-Carvalho A, Mill JG, Martins-Filho OA, Valim V. Third Booster Half Dose of ChAdOx1-nCov-19 Is Effective, Safe, and Induces Long-Duration Humoral and Cellular Immune Response to Omicron: 1-Year Follow-Up of Viana Study. Vaccines (Basel). 2025 Oct 30;13(11):1113. doi: 10.3390/vaccines13111113.

  PMID: 41295486 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19

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

Central Study Contacts

Valéria Valim, PhD

CONTACT

+5527999874665; val.valim@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 28, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 30, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

BR (1)