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

NCT ID: NCT04967742

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2021-10-31

Brief 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.

Detailed 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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A group: 1 booster dose of UB-612 vaccine 100 μg

1 booster dose for subjects at UB-612 vaccine 10 μg in V-122 study.

Group Type: EXPERIMENTAL

UB-612

Intervention Type: BIOLOGICAL

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.

B group: 1 booster dose of UB-612 vaccine 100 μg

1 booster dose for subjects at UB-612 vaccine 30 μg in V-122 study.

Group Type: EXPERIMENTAL

UB-612

Intervention Type: BIOLOGICAL

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.

C group: 1 booster dose of UB-612 vaccine 100 μg

1 booster dose for subjects at UB-612 vaccine 100 μg in V-122 study.

Group Type: EXPERIMENTAL

UB-612

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vaxxinity, Inc.

INDUSTRY

Sponsor Role: collaborator

United Biomedical Inc., Asia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang-Yi Wang, Ph.D

Role: STUDY_CHAIR

United Biomedical Inc., Asia

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

Wang CY, Hwang KP, Kuo HK, Peng WJ, Shen YH, Kuo BS, Huang JH, Liu H, Ho YH, Lin F, Ding S, Liu Z, Wu HT, Huang CT, Lee YJ, Liu MC, Yang YC, Lu PL, Tsai HC, Lee CH, Shi ZY, Liu CE, Liao CH, Chang FY, Chen HC, Wang FD, Hou KL, Cheng J, Wang MS, Yang YT, Chiu HC, Jiang MH, Shih HY, Shen HY, Chang PY, Lan YR, Chen CT, Lin YL, Liang JJ, Liao CC, Chou YC, Morris MK, Hanson CV, Guirakhoo F, Hellerstein M, Yu HJ, King CC, Kemp T, Heppner DG, Monath TP. A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. J Clin Invest. 2022 May 16;132(10):e157707. doi: 10.1172/JCI157707.

Reference Type: DERIVED

PMID: 35316221 (View on PubMed)

Other Identifiers

V-123

Identifier Type: -

Identifier Source: org_study_id