A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers

• ClinicalTrials.gov Identifier: NCT04773067
• Recruitment Status: Terminated
• First Posted: February 26, 2021
• Last Update Posted: August 26, 2022
• Sponsor: United Biomedical Inc., Asia
• Collaborator: Vaxxinity, Inc.
• Information provided by (Responsible Party): United Biomedical Inc., Asia

Study Description

Brief Summary:

This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Around 3850 adult subjects will be randomized to be composed of the core group, while around 385 adolescents will be randomized to be the supplementary group. Subjects will be unblinded at Visit 5, and subjects in the vaccine group will be encouraged to have 3rd dose of vaccination.

Condition or disease	Intervention/treatment	Phase
COVID-19	Biological: UB-612; Biological: Placebo	Phase 2

Detailed Description:

This clinical study will be consisted of 7 clinical visits and one long-term follow-up visit. Subjects will also be unblinded at Visit 5, subjects in placebo group will withdraw from the study and subjects in vaccine group will be encouraged to have 3rd dose of vaccination (Day 197~Day 242) at Visit 6. Those who received 3rd dose will have Visit 7 (14 days after Visit 6) to check the booster effect. After Day 197, subjects will enter the long-term follow-up with a safety call bi-monthly.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3877 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase II, Placebo-controlled, Randomized, Observer-blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of UB-612 Vaccine Against COVID-19 in Adolescent, Younger and Elderly Adult Volunteers
• Actual Study Start Date: January 30, 2021
• Actual Primary Completion Date: March 8, 2022
• Actual Study Completion Date: March 8, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: UB-612; A proprietary high-precision designer S1-RBD protein based vaccine incorporating Th/CTL peptides to activate T cells.	Biological: UB-612; Around 3300 adult subjects and 330 adolescent subjects will receive 2 doses of 100 µg UB-612 vaccine. The subjects will be invited to have the 3rd dose after unblinded.
Placebo Comparator: Placebo; Normal saline 0.9%.	Biological: Placebo; Around 550 adult subjects and 55 adolescent subjects will receive 2 doses of normal saline 0.9%.

Outcome Measures

Primary Outcome Measures :

1. Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody [ Time Frame: Day 57 ]
   Immunogenicity evaluation
2. Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
   Immunogenicity evaluation
3. Local reactions and systemic events [ Time Frame: Up to 7 days following each dose ]
   Safety evaluation
4. Unsolicited adverse events [ Time Frame: Day 1 to Day 57 ]
   Safety evaluation
5. Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs) [ Time Frame: Day 1 to Day 365 ]
   Safety evaluation

Secondary Outcome Measures :

1. SCR of anti-S1-RBD antibody [ Time Frame: Day 57 ]
   Immunogenicity evaluation
2. GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 197 and 365 ]
   Immunogenicity evaluation
3. GMT of anti-S1-RBD antibody [ Time Frame: Day 57, 197 and 365 ]
   Immunogenicity evaluation
4. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD) [ Time Frame: Day 57, 197 and 365 ]
   Immunogenicity evaluation
5. Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 57 ]
   Evaluation of lot to lot consistency

Other Outcome Measures:

1. Antigen-specific interferon-gamma (IFN-γ) and IL-4 production measured by ELISpot [ Time Frame: Day 57 and 14 days post 3rd dose ]
   Evaluation of T cell function induced by UB-612
2. CD4+ and CD8+ T cell responses measured by flow cytometric assays [ Time Frame: Day 57 and 14 days post 3rd dose ]
   Evaluation of T cell function induced by UB-612
3. GMT of SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days post 3rd dose ]
   Immunogenicity evaluation
4. GMT of anti-S1-RBD antibody [ Time Frame: 14 days post 3rd dose ]
   Immunogenicity evaluation
5. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody [ Time Frame: 14 days post 3rd dose ]
   Immunogenicity evaluation
6. GMT of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57, Day 197 and Day 365 ]
   Immunogenicity evaluation
7. SCR of SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57 ]
   Immunogenicity evaluation
8. Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and anti-S1-RBD antibody in adolescents [ Time Frame: Day 57, Day 197, and Day 365 ]
   Immunogenicity evaluation
9. Safety evaluation in adolescents [ Time Frame: Day 1 to Day 365 ]
   1. Local reactions and systemic events for up to 7 days following each dose
   2. Unsolicited AEs from Day 1 to Day 57
   3. MAAEs, SAEs, AESIs and ADEs from Day 1 to Day 365
10. Incidence of COVID-19 cases [ Time Frame: Day 1 to Day 365 ]
    COVID-19 incidence per 1000 person-years of follow-up
11. Antibody against SARS-CoV-2 antigens measured by ELISA [ Time Frame: Day 1 to Day 365 ]
    Antigens derived from S2, N and M protein.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy male or non-pregnant female between the age of 12 to 85 years at time of enrolment.
• Women of childbearing potential and men must agree to practice medically effective contraception from first vaccination until 3 months after the last vaccination.
• Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
• Able to understand and agrees to comply with all study procedures and be available for all study visits.
• Ear temperature ≤ 38.0°C.
• Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. In the investigator's clinical judgement, participant may have a stable and well-controlled comorbidity associated with an increased risk of progression to severe COVID-19.

Exclusion Criteria:

• History of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
• Female who is pregnant or positive in pregnancy test at screening or just prior to each vaccination administration.
• Female who is breast-feeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
• Any acute illness, as determined by the study investigator 3 days before first vaccination (these subjects can be re-scheduled).
• Any major surgery one month before first vaccination (these subjects can be -rescheduled).
• Known HIV antibody positive.
• Known active hepatitis B and hepatitis C disease.
• Previous exposure to SARS-CoV-2 or receipt of an investigational or licensed product for the prevention of COVID-19, MERS or SARS.
• Have history of Guillain-Barre syndrome.
• Subjects who take part in another clinical study within 12 weeks prior to the day of informed consent.
• Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or immunosuppressive therapy.
• Subjects who plan to or are undergoing anti-cancer therapy.
• Platelet disorder or other bleeding disorder may cause injection contraindication.
• Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
• Prior administration of immunoglobulins and/or any blood products in last 4 months before first vaccination.
• Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other non-study vaccine within 28 days, before study intervention administration.
• Anticipated receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, after study intervention administration.
• Receipt of short-term (<14 days) systemic corticosteroids. Study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Loss or donation of blood over 500 mL within 3 months prior to Screening Visit or intention to donate blood or blood products for transfusion during the study.
• 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.
• Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) who directly involved in the conduct of the study.

Contacts and Locations

Locations

Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Taoyuan, Taiwan

Sponsors and Collaborators

United Biomedical Inc., Asia

Vaxxinity, Inc.

Investigators

• Study Chair: Chang-Yi Wang, Ph.D.; United Biomedical Inc., Asia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: United Biomedical Inc., Asia
• ClinicalTrials.gov Identifier: NCT04773067
• Other Study ID Numbers: V-205
• First Posted: February 26, 2021
• Last Update Posted: August 26, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases