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

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ClinicalTrials.gov Identifier: NCT04683224
Recruitment Status : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
Diagnósticos da América S/A (DASA)
Information provided by (Responsible Party):
COVAXX

Tracking Information
First Submitted Date  ICMJE December 10, 2020
First Posted Date  ICMJE December 24, 2020
Last Update Posted Date December 24, 2020
Estimated Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date March 22, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs [ Time Frame: Day 1 to 24 months ]
    Safety and Tolerability
  • Change in safety chemistry blood lab values for assessment of risk in Phase 3 [ Time Frame: Phase 2 -Day 1 to Day 36 ]
    Percentage of subjects with changes in lab values at different time points
  • Change in safety hematology blood lab values for assessment of risk in Phase 3 [ Time Frame: Phase 2 -Day 1 to Day 36 ]
    Percentage of subjects with changes in lab values at different time points
  • Prevention of SARS-CoV-2 infection in adults [ Time Frame: Day 29 to 24 Month ]
    SARS-CoV-2 incidence based on qPCR nasopharyngeal swab
  • Change after second dose through the end of study in antibody titers [ Time Frame: Month 1, 6, 12 and 24 following Dose 2 ]
    Immunogenicity of UB-612 vaccine
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • Prevention of COVID-19 in adults [ Time Frame: Day 42 to 24 Month ]
    COVID-19 incidence confirmed by qPCR nasopharyngeal swab
  • Reduction in severity of COVID-19 in adults [ Time Frame: Day 42 to 24 Month ]
    Efficacy of UB-612 vaccine
  • Prevention of COVID-19 death in adults [ Time Frame: Day 42 to 24 Month ]
    Efficacy of UB-612 vaccine
  • Change in SARS CoV-2 shedding [ Time Frame: Day 42 to 24 Month ]
    Measured by comparing the SARS-CoV-2 shedding in vaccine and placebo subjects
  • Immunogenicity of UB-612 vaccine in young and older adults, with or without comorbidities, and no serological or virological evidence of past infection with SARS-CoV-2 [ Time Frame: baseline, 7 days, 6, 12, and 24 months after Dose 2 ]
    Number of cytokine secreting spots
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 23, 2020)
Change in SARS CoV-2 infection [ Time Frame: Month 1, 6, 12 and 24 following Dose 2 ]
Efficacy of UB-612 vaccine
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine
Official Title  ICMJE A Phase 2/3 Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 Vaccine in Adults
Brief Summary This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.
Detailed Description

This Phase 2/3 trial will enroll a total of 7320 male and female subjects randomized in a double-blind manner to receive either UB-612 or placebo. Assignment will be stratified by age (18 to 59 years and ≥60 years) and by presence/absence of comorbidities.

All subjects will receive 2 doses of the study vaccine, separated by 28 days, as an intramuscular (IM) injection.

Phase 2 and Phase 3 will start simultaneously; Phase 2 will enroll all Strata #1 to #4; Phase 3 will enroll Stratum #1 until the Data and Safety Monitoring Board (DSMB) has reviewed Phase 2 data through Day 43 and endorsed enrolment of Strata #2 to #4. All subjects in Phase 2 and Phase 3 will be followed for safety and efficacy.

This Phase 2/3 study also contains a Safety and Immunogenicity Cohort (N=1300) consisting of 1000 SARS-CoV-2 seronegative subjects (320 subjects enrolled in Phase 2 and 680 subjects enrolled in Phase 3) and 300 SARS-CoV-2 seropositive subjects enrolled in Phase 3.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid-19
  • SARS-CoV-2
  • Coronavirus
Intervention  ICMJE
  • Biological: UB-612
    100 µg [microgram] of an experimental study vaccine
  • Other: Placebo
    Placebo is a 0.9% sodium chloride (normal saline) injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo Stratum 1: 18 to 59 age group without comorbidities
    Placebo by intramuscular injection at Day 1 and 29
    Intervention: Other: Placebo
  • Experimental: UB-612 Stratum 1: 18 to 59 age group without comorbidities
    UB-612 by intramuscular injection at Day 1 and 29
    Intervention: Biological: UB-612
  • Placebo Comparator: Placebo Stratum 2: ≥60 age group without comorbidities
    Placebo by intramuscular injection at Day 1 and 29
    Intervention: Other: Placebo
  • Experimental: UB-612 Stratum 2: ≥60 age group without comorbidities
    UB-612 by intramuscular injection at Day 1 and 29
    Intervention: Biological: UB-612
  • Placebo Comparator: Placebo Stratum 3: 18 to 59 age group with comorbidities
    Placebo by intramuscular injection at Day 1 and 29
    Intervention: Other: Placebo
  • Experimental: UB-612 Stratum 3: 18 to 59 age group with comorbidities
    UB-612 by intramuscular injection at Day 1 and 29
    Intervention: Biological: UB-612
  • Placebo Comparator: Placebo Stratum 4: ≥60 age group with comorbidities
    Placebo by intramuscular injection at Day 1 and 29
    Intervention: Other: Placebo
  • Experimental: UB-612 Stratum 4: ≥60 age group with comorbidities
    UB-612 by intramuscular injection at Day 1 and 29
    Intervention: Biological: UB-612
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 23, 2020)
7320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 22, 2023
Estimated Primary Completion Date March 22, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understands and agrees to comply with the study procedures and provides written informed consent.
  2. Passes written comprehension test outlining study procedures.
  3. Male or female, aged 18 to 59 years or aged >60 years at randomization.
  4. Canadian Frailty Scale score of 0 to 6 (see Appendix 1).
  5. Women of childbearing potential (WOCBP) and men must agree to practice medically effective contraception from 28 days before the first vaccination until 1 month after the last vaccination (i.e., a 3-month period). The acceptable effective contraception methods include the following:

    1. Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
    2. Intrauterine device
    3. Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
    4. Sterilization of a female participant's monogamous male partner prior to entry into the study
    5. Abstinence
  6. For WOCBP, serum pregnancy test must be negative at screening; urine pregnancy test must be negative within 24 hours before vaccination.
  7. Lactating female participants must agree not to breastfeed or store breast milk for 3 days after each vaccination. A substituted formula is recommended during these periods.
  8. Negative serum antibodies (IgG) against SARS-CoV-2 N protein at screening except for 300 subjects in the seropositive cohort (Phase 3 only).
  9. Negative result for RT-PCR screening of saliva or nasal mid-turbinate sample for SARS-CoV-2 within 2 days before vaccination.
  10. At high risk of SARS-CoV-2 exposure due to occupation (e.g., health care providers, first responders, service industry workers, etc.), residence (multi-generational home, long-term care facilities, etc.), or environment with high incidence (e.g., public transportation), including geographic area.
  11. Judged to be healthy or stable with pre-existing medical condition that did not require significant change in medication or hospitalization in 3 months before enrollment or who, in the judgement of the investigator are unlikely to require a significant change in therapy or hospitalization for worsening disease in the 3 months after enrollment.
  12. Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) system.
  13. Plans to reside within study area for the duration of the study.
  14. Able to comply with study procedures, in the opinion of the investigator.

Exclusion Criteria:

  1. Positive for SARS-CoV-2 shedding or self-reported history of prior infection with SARS CoV-2.
  2. Seropositive for SARS-CoV-2, except for 300 subjects in the seropositive cohort in Phase 3 only.
  3. Moderate or severe illness and/or fever >100.4°F/38°C within 1 week before vaccination. Screening and/or study vaccination may be rescheduled at the discretion of the investigator.
  4. Canadian Frailty Scale score of ≥7 (see Appendix 1).
  5. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
  6. Coronavirus vaccines: Previous receipt of SARS-CoV-2 vaccine or other investigational coronavirus vaccine (SARS-CoV, MERS-CoV) at any time.
  7. Investigational non-coronavirus vaccines: Previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of the first dose of study vaccine.
  8. Licensed vaccines: Participant received or plans to receive: (a) licensed live attenuated vaccines or licensed adjuvanted (non-aluminum compound) vaccine within 28 days before or after planned administration of study vaccine, and (b) other licensed (not noted above) vaccines within 14 days before or after planned administration of study vaccine.
  9. Immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, recurrent severe infections.
  10. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study.
  11. Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥20 mg/day of prednisone equivalent).
  12. Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
  13. Has donated ≥450 mL of blood products within 28 days prior to screening.
  14. Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days. However, participants who received specific anti-SARS-CoV-2 monoclonal antibody products (e.g., REGN-COV2) at any time are permanently excluded, even if such product was given as part of a normal volunteer study.
  15. Currently enrolled or plans to participate in another investigational study (drug, vaccine, or device) during this study.
  16. Pregnant.
  17. Lactating women who are unwilling or unable to withhold breastfeeding and storing milk for 3 days after each vaccination.
  18. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  19. Tattoos or scars at the deltoid sites of IM injection that would obscure injection site reactions.
  20. Behavioral, cognitive, or psychiatric disease that, in the opinion of the Principal Investigator or his or her representative physician, affects the participant's ability to understand and cooperate with all study protocol requirements.
  21. Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history.
  22. Any other condition that, in the opinion of the Principal Investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tracy Kemp 508-292-9337 tracy@covaxx.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04683224
Other Study ID Numbers  ICMJE UB-612-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party COVAXX
Study Sponsor  ICMJE COVAXX
Collaborators  ICMJE Diagnósticos da América S/A (DASA)
Investigators  ICMJE
Study Chair: Gray Heppner Chief Medical Officer
PRS Account COVAXX
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP