Clinical trial NCT04967742: A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Official title: A Phase I, Open-Label Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 Vaccine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: United Biomedical Inc., Asia
Sponsor class: INDUSTRY
Collaborators: name: Vaxxinity, Inc.
First posted: 2021-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: GMT of neutralizing antibody against SARS-CoV-2
timeFrame: Day 1
measure: GMT of neutralizing antibody against SARS-CoV-2
timeFrame: Day 15
measure: GMT of neutralizing antibody against SARS-CoV-2
timeFrame: Day 85
measure: Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
timeFrame: Day 15
measure: Geometric mean fold increase of neutralizing antibody against SARS-CoV-2
timeFrame: Day 85
measure: Occurrence of adverse reactions and the percentage of subjects with ≥ Grade 3 adverse events
timeFrame: Within 7 days after vaccination
Secondary outcomes:
measure: GMT of antigen-specific antibody (Anti-S1-RBD)
timeFrame: Day 1
measure: GMT of antigen-specific antibody (Anti-S1-RBD)
timeFrame: Day 15
measure: GMT of antigen-specific antibody (Anti-S1-RBD)
timeFrame: Day 85
measure: Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
timeFrame: Day 15
measure: Geometric mean fold increase of antigen-specific antibody (Anti-S1-RBD)
timeFrame: Day 85
measure: Correlation between the immune response detected by ELISA and live virus neutralization test
timeFrame: During the study period
measure: Occurrence of SAEs, AESIs, MAAEs and SAEs
timeFrame: During the study period
Other outcomes:
measure: T cell responses to UB-612 COVID-19 Vaccine
timeFrame: Day 1
measure: T cell responses to UB-612 COVID-19 Vaccine
timeFrame: Day 15
measure: T cell responses to UB-612 COVID-19 Vaccine
timeFrame: Day 85
measure: GMT of neutralizing antibody against SARS-CoV-2 variants
timeFrame: Day 1
measure: GMT of neutralizing antibody against SARS-CoV-2 variants
timeFrame: Day 15
measure: GMT of neutralizing antibody against SARS-CoV-2 variants
timeFrame: Day 85
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: United Biomedical Inc., Asia
name: Chang-Yi Wang, Ph.D
role: STUDY_CHAIR
References:
citation: 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.