Safety of UFRJvac, Trivalent COVID-19 Vaccine

NCT06303635 | Not Yet Recruiting

• 1 other identifier: UFRJvac-1
• Study Type: observational
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.

Conditions

Healthy People

Keywords

UFRJvac

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster

  Incidence, causality, severity and intensity of reported adverse events

  Up to 7 days after administration.

Secondary Outcomes (6)

• Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19

  28, 84 and 168 days after administration.

• Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19

  28, 84 and 168 days after vaccination.

• Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19

  28, 84 and 168 days after vaccination.

• Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac

  28, 84 and 168 days after vaccination.

• Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac

  28, 84 and 168 days after vaccination.

Eligibility Criteria

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

Study Population

The study will include 156 male or female participants aged between 18 and 65 years, with complete primary vaccination for COVID-19 and at least one booster dose, the last being carried out with the Comirnaty Bivalent BA.4/BA vaccine. 5.

You may qualify if:

• Male or female.
• Age from 18 to 65 years old, inclusive.
• Body mass index (BMI) between 19.0 and 35.0 kg/m2, inclusive.
• Female participant with a negative pregnancy test on the day of vaccination.
• Consent form voluntarily signed before any procedure.

You may not qualify if:

• Confirmation of active SARS-CoV-2 infection in rapid antigen test screening.
• History of serious adverse reaction to any vaccine, medication or component of the investigational product.
• History of immunodeficiency, autoimmune diseases and cardiomyopathies.
• History of malignancy within 1 year before screening (except basal cell carcinoma of the skin or in situ carcinoma of the cervix, which have already resolved).
• History of uncontrolled coagulopathy or blood disorders that contraindicate intramuscular injection.
• History of uncontrolled epilepsy or other progressive neurological disorders such as Guillain-Barré Syndrome.
• Treatment with immunosuppressive medications in the 3 months prior to the first vaccination or 6 months for chemotherapy.
• History of systemic steroids (prednisone ≥ 20 mg/day or equivalent for \>14 consecutive days) within 3 months prior to screening. Topical, inhaled, intranasal, and intra-articular corticosteroids are permitted regardless of dose.
• Use of any other vaccine less than 14 days before or planning to use up to 29 days after V0.
• Presence of tattoos, scars, skin discoloration or any other skin disorders at the injection site that, in the opinion of the investigator, may impair the assessment of local reactogenicity.
• Any condition that, in the opinion of the investigator, endangers the safety or rights of the participant or makes the participant unsuitable for the study.
• Clinically significant changes in safety examinations, defined as:
• Hb ≤ 10.9 g/dL;
• Leukocyte count \< 2500 cells/mm3;
• Absolute neutrophil count \< 1000 cells/mm3;

Sponsors & Collaborators

• Azidus Brasil: lead
• Universidade Federal do Rio de Janeiro: collaborator

Study Officials

• Jose Cerbino Neto, MD

  Instituto D'Or de Ensino e Pesquisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leda Castilho, PhD

CONTACT

+ 55 21 3733-1985; leda@peq.coppe.ufrj.br

Luciana Ferrara

CONTACT

+55 19 99523 7888; luciana.ferrara@azdcro.com.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 12, 2024
• Study Start: June 24, 2024
• Primary Completion: October 16, 2025
• Study Completion: November 25, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share