Healthy PeopleUFRJvac-1NCT06303635
Safety of UFRJvac, Trivalent COVID-19 Vaccine
An observational study of Healthy People, run by Azidus Brasil.
Trial summary
Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2024to 25 Nov 2025
- How long will I take part?
- 6 Months
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male or female.
- Age from 18 to 65 years old, inclusive.
- Complete primary vaccination for COVID-19 with one of the vaccines approved by ANVISA for use in Brazil, and at least one booster, the last of which must be with Comirnaty Bivalente BA.4/BA.5 between 4 and 18 months before vaccination. inclusion.
- 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.
Who cannot join
- 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 medium or major surgery within 3 months before inclusion.
- 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.
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- History of uncontrolled epilepsy or other progressive neurological disorders such as Guillain-Barré Syndrome.
- Any decompensated chronic disease at the time of inclusion.
- 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.
- Use of blood products in the 3 months before inclusion.
- Use of another investigational product within 1 year before inclusion.
- Pregnancy or breastfeeding at inclusion or planned during the study.
- Fever or any acute illness within 1 week before inclusion. Participants who do not meet this criterion may be rescheduled for a new inclusion visit.
- 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;
- ESR outside normal values (18 to 65 years old, male - 2 to 28 mm; 18 to 65 years old, female - 2 to 36 mm);
- ALT, AST and FA > 1.25 x ULN;
- Total bilirubin > 1.1 x ULN;
- Creatinine > 1.1 x ULN;
- Glycated hemoglobin > 5.6%;
- Troponin 1 > 0.16 ng/mL;
- TP and aPTT > 1.1 x ULN;
- CPK outside normal values (male adults - 38 to 174 U/L; female adults - 26 to 140 U/L);
- C-reactive protein > 1.0 mg/dL.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I Study to Evaluate the Safety and Immunogenicity of the Vaccine Booster With the Trivalent UFRJvac COVID-19 Vaccine
Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.
Read the detailed description
Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.
UFRJvac COVID-19 is a trivalent vaccine for preventing COVID-19. It is a protein subunit vaccine, being formulated with the entire recombinant spike protein ("S" protein, amino acids 1-1208) of the D614G, gamma and delta variants of SARS-CoV-2. One spike protein from each variant is expressed in HEK293 cells in trimeric form and stabilized in the prefusion conformation. In order for the adaptive immune response (humoral and cellular) to be enhanced against these proteins, the vaccine is formulated with the GLA-SE adjuvant.
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.
UFRJvac COVID-19 will be administered once, as a booster dose, intramuscularly (0.5 mL), in doses of 5 μg or 15 μg of antigens.
Participants receive the investigational product on D0 and return for in-person medical evaluation on D2, D28, D84 and D168. Blood samples will be collected for humoral and cellular immunity tests on days D28, D84 and D168. On days D1, D3, D4, D5, D6 and D7 participants will be contacted by telephone to collect adverse events. Inclusion will be staggered, starting with 6 participants receiving PSI at a dose of 5 μg and distributed over at least 3 days. If tolerability is good, another 6 participants will receive the same dose and will also be distributed over at least 3 days. If tolerability is good, another 6 participants will receive the same dose and will be distributed over at least 3 days, totaling 18 participants with the lowest dose. If tolerability is good, another 18 participants receiving 15 μg will be included, also divided into 3 groups of 6 participants with at least 3 days of observation. If tolerability is good, an additional 120 participants will be included, 60 receiving the 5 μg dose and 60 receiving the 15 μg dose.
The main benefit of UFRJvac COVID-19 is to induce adaptive immunity against the three variants of SARS-CoV-2 (D614G, gamma and delta), and this combination of three antigens resulted, in preclinical studies, in a specific immune response also against the omicron variant. As this is a phase I study, there is still no data on adverse events related to the experimental drug. However, initially, reactions are expected at the site of product administration.
- Conditions
- Healthy People
- Keywords
- UFRJvac
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster
Incidence, causality, severity and intensity of reported adverse events
Measured: Up to 7 days after administration.
Secondary outcomes (6)
Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Incidence, causality, severity and intensity of adverse events reported
Measured: 28, 84 and 168 days after administration.
Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Increase in relation to the screening values of the geometric mean of the titer of neutralizing antibodies against the Wuhan and Ômicron variants of SARS-CoV-2
Measured: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19
Percentage of participants with a 4-fold or greater increase from screening values in neutralizing antibody titers against the Wuhan and Omicron variants of SARS-CoV-2
Measured: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac
Increase in relation to the screening values of the geometric mean of the binding antibody (IgG) titer specific for protein S
Measured: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac
Percentage of participants with a 4-fold or greater increase from screening values in protein S-specific binding antibody (IgG) levels
Measured: 28, 84 and 168 days after vaccination.
Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Increase over screening values in levels of IFN-γ, IL-2, TNF-α, IL4, IL5, and IL13 in culture supernatants from participant PBMCs
Measured: 28, 84 and 168 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start24 Jun 2024 (estimated)
- Primary completion16 Oct 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Rio de Janeiro
- Responsible party
- Sponsor
- Investigators
- Jose Cerbino Neto, MD, Principal investigator, Instituto D'Or de Ensino e Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303635
- Sponsor's protocol ID
- UFRJvac-1
- Acronym
- UFRJvac-1
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety and Immunogenicity of the Vaccine Booster With the Trivalent UFRJvac COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT06303635
- Acronym / sponsor ID
- UFRJvac-1 / UFRJvac-1
- Conditions
- Healthy People
- Keywords
- UFRJvac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Rio de Janeiro
- Study start
- 24 Jun 2024 (estimated)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.
Detailed description
Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.
UFRJvac COVID-19 is a trivalent vaccine for preventing COVID-19. It is a protein subunit vaccine, being formulated with the entire recombinant spike protein ("S" protein, amino acids 1-1208) of the D614G, gamma and delta variants of SARS-CoV-2. One spike protein from each variant is expressed in HEK293 cells in trimeric form and stabilized in the prefusion conformation. In order for the adaptive immune response (humoral and cellular) to be enhanced against these proteins, the vaccine is formulated with the GLA-SE adjuvant.
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.
UFRJvac COVID-19 will be administered once, as a booster dose, intramuscularly (0.5 mL), in doses of 5 μg or 15 μg of antigens.
Participants receive the investigational product on D0 and return for in-person medical evaluation on D2, D28, D84 and D168. Blood samples will be collected for humoral and cellular immunity tests on days D28, D84 and D168. On days D1, D3, D4, D5, D6 and D7 participants will be contacted by telephone to collect adverse events. Inclusion will be staggered, starting with 6 participants receiving PSI at a dose of 5 μg and distributed over at least 3 days. If tolerability is good, another 6 participants will receive the same dose and will also be distributed over at least 3 days. If tolerability is good, another 6 participants will receive the same dose and will be distributed over at least 3 days, totaling 18 participants with the lowest dose. If tolerability is good, another 18 participants receiving 15 μg will be included, also divided into 3 groups of 6 participants with at least 3 days of observation. If tolerability is good, an additional 120 participants will be included, 60 receiving the 5 μg dose and 60 receiving the 15 μg dose.
The main benefit of UFRJvac COVID-19 is to induce adaptive immunity against the three variants of SARS-CoV-2 (D614G, gamma and delta), and this combination of three antigens resulted, in preclinical studies, in a specific immune response also against the omicron variant. As this is a phase I study, there is still no data on adverse events related to the experimental drug. However, initially, reactions are expected at the site of product administration.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Male or female.
- Age from 18 to 65 years old, inclusive.
- Complete primary vaccination for COVID-19 with one of the vaccines approved by ANVISA for use in Brazil, and at least one booster, the last of which must be with Comirnaty Bivalente BA.4/BA.5 between 4 and 18 months before vaccination. inclusion.
- 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.
Key exclusion criteria (30 listed)
- 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 medium or major surgery within 3 months before inclusion.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster
Time frame: Up to 7 days after administration.
Incidence, causality, severity and intensity of reported adverse events
6 secondary outcomes
Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Time frame: 28, 84 and 168 days after administration.
Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Time frame: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19
Time frame: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac
Time frame: 28, 84 and 168 days after vaccination.
Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac
Time frame: 28, 84 and 168 days after vaccination.
Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19
Time frame: 28, 84 and 168 days after vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Cerbino Neto, MD principal investigator
Instituto D'Or de Ensino e Pesquisa
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People, run by Azidus Brasil.
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 6 inclusion and 30 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Leda Castilho, PhD (+ 55 21 3733-1985, leda@peq.coppe.ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster (time frame: Up to 7 days after administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.