Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-27 @ 11:54 AM
Study NCT ID:
NCT06303635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of UFRJvac, Trivalent COVID-19 Vaccine
Sponsor:
Azidus Brasil
Organization:
Study Overview
Official Title:
Phase I Study to Evaluate the Safety and Immunogenicity of the Vaccine Booster With the Trivalent UFRJvac COVID-19 Vaccine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UFRJvac-1
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: