A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:

A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967742
• Other study ID #: V-123
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: United Biomedical Inc., Asia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.

Description:

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2021
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

• Inclusion Criteria

1. Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.

2. Women of childbearing potential and men must agree to practice medically effective contraception during study period.

3. Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).

4. Able to understand and agrees to comply with all study procedures and be available for all study visits.

5. Ear temperature = 38.0°C.

6. At screening visit, at least 6 months after first vaccination in the V-122 study.

• Exclusion Criteria

1. Female who is pregnant or positive in pregnancy test at screening visit.

2. Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.

3. Any acute illness, as determined by the study investigator 3 days before booster vaccination.

4. Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination.

5. Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination.

6. Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study.

7. Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612.

8. Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.

9. Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.

10. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• UB-612
UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
United Biomedical Inc., Asia	Vaxxinity, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 1
Other	T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 15
Other	T cell responses to UB-612 COVID-19 Vaccine	Evaluation of Immunogenicity	Day 85
Other	GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 1
Other	GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 15
Other	GMT of neutralizing antibody against SARS-CoV-2 variants	Evaluation of Immunogenicity	Day 85
Primary	GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 1
Primary	GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 15
Primary	GMT of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 85
Primary	Geometric mean fold increase of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 15
Primary	Geometric mean fold increase of neutralizing antibody against SARS-CoV-2	Evaluation of Immunogenicity	Day 85
Primary	Occurrence of adverse reactions and the percentage of subjects with = Grade 3 adverse events	Evaluation of Safety	Within 7 days after vaccination
Secondary	GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 1
Secondary	GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 15
Secondary	GMT of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 85
Secondary	Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 15
Secondary	Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)	Evaluation of Immunogenicity	Day 85
Secondary	Correlation between the immune response detected by ELISA and live virus neutralization test	Evaluation of Immunogenicity	During the study period
Secondary	Occurrence of SAEs, AESIs, MAAEs and SAEs	Evaluation of Safety	During the study period