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

NCT04683224 | Withdrawn Phase 2 DMC

• 1 other identifier: UB-612-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid-19; SARS-CoV-2; Coronavirus

Outcome Measures

Primary Outcomes (5)

• The incidence of local reactions, solicited systemic events, AEs, MAAEs, SAEs and AESIs

  Safety and Tolerability

  Day 1 to 24 months

• Change in safety chemistry blood lab values for assessment of risk in Phase 3

  Percentage of subjects with changes in lab values at different time points

  Phase 2 -Day 1 to Day 36

• Change in safety hematology blood lab values for assessment of risk in Phase 3

  Percentage of subjects with changes in lab values at different time points

  Phase 2 -Day 1 to Day 36

• Prevention of SARS-CoV-2 infection in adults

  SARS-CoV-2 incidence based on qPCR nasopharyngeal swab

  Day 29 to 24 Month

• Change after second dose through the end of study in antibody titers

  Immunogenicity of UB-612 vaccine

  Month 1, 6, 12 and 24 following Dose 2

Secondary Outcomes (5)

• Prevention of COVID-19 in adults

  Day 42 to 24 Month

• Reduction in severity of COVID-19 in adults

  Day 42 to 24 Month

• Prevention of COVID-19 death in adults

  Day 42 to 24 Month

• Change in SARS CoV-2 shedding

  Day 42 to 24 Month

• 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

  baseline, 7 days, 6, 12, and 24 months after Dose 2

Other Outcomes (1)

• Change in SARS CoV-2 infection

  Month 1, 6, 12 and 24 following Dose 2

Study Arms (8)

Placebo Stratum 1: 18 to 59 age group without comorbidities

PLACEBO COMPARATOR

Placebo by intramuscular injection at Day 1 and 29

Other: Placebo

UB-612 Stratum 1: 18 to 59 age group without comorbidities

EXPERIMENTAL

UB-612 by intramuscular injection at Day 1 and 29

Biological: UB-612

Placebo Stratum 2: ≥60 age group without comorbidities

PLACEBO COMPARATOR

Placebo by intramuscular injection at Day 1 and 29

Other: Placebo

UB-612 Stratum 2: ≥60 age group without comorbidities

EXPERIMENTAL

UB-612 by intramuscular injection at Day 1 and 29

Biological: UB-612

Placebo Stratum 3: 18 to 59 age group with comorbidities

PLACEBO COMPARATOR

Placebo by intramuscular injection at Day 1 and 29

Other: Placebo

UB-612 Stratum 3: 18 to 59 age group with comorbidities

EXPERIMENTAL

UB-612 by intramuscular injection at Day 1 and 29

Biological: UB-612

Placebo Stratum 4: ≥60 age group with comorbidities

PLACEBO COMPARATOR

Placebo by intramuscular injection at Day 1 and 29

Other: Placebo

UB-612 Stratum 4: ≥60 age group with comorbidities

EXPERIMENTAL

UB-612 by intramuscular injection at Day 1 and 29

Biological: UB-612

Interventions

UB-612 BIOLOGICAL

100 µg \[microgram\] of an experimental study vaccine

UB-612 Stratum 1: 18 to 59 age group without comorbidities; UB-612 Stratum 2: ≥60 age group without comorbidities; UB-612 Stratum 3: 18 to 59 age group with comorbidities; UB-612 Stratum 4: ≥60 age group with comorbidities

Placebo OTHER

Placebo is a 0.9% sodium chloride (normal saline) injection

Placebo Stratum 1: 18 to 59 age group without comorbidities; Placebo Stratum 2: ≥60 age group without comorbidities; Placebo Stratum 3: 18 to 59 age group with comorbidities; Placebo Stratum 4: ≥60 age group with comorbidities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understands and agrees to comply with the study procedures and provides written informed consent.
• Passes written comprehension test outlining study procedures.
• Male or female, aged 18 to 59 years or aged \>60 years at randomization.
• Canadian Frailty Scale score of 0 to 6 (see Appendix 1).
• 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:
• Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
• Intrauterine device
• Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
• Sterilization of a female participant's monogamous male partner prior to entry into the study
• Abstinence
• For WOCBP, serum pregnancy test must be negative at screening; urine pregnancy test must be negative within 24 hours before vaccination.
• 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.
• Negative serum antibodies (IgG) against SARS-CoV-2 N protein at screening except for 300 subjects in the seropositive cohort (Phase 3 only).
• Negative result for RT-PCR screening of saliva or nasal mid-turbinate sample for SARS-CoV-2 within 2 days before vaccination.
• 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.

You may not qualify if:

• Positive for SARS-CoV-2 shedding or self-reported history of prior infection with SARS CoV-2.
• Seropositive for SARS-CoV-2, except for 300 subjects in the seropositive cohort in Phase 3 only.
• 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.
• Canadian Frailty Scale score of ≥7 (see Appendix 1).
• History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
• Coronavirus vaccines: Previous receipt of SARS-CoV-2 vaccine or other investigational coronavirus vaccine (SARS-CoV, MERS-CoV) at any time.
• 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.
• 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.
• Immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, recurrent severe infections.
• 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.
• 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).
• Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
• Has donated ≥450 mL of blood products within 28 days prior to screening.
• 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.
• Currently enrolled or plans to participate in another investigational study (drug, vaccine, or device) during this study.

Sponsors & Collaborators

• Vaxxinity, Inc.: lead
• Diagnósticos da América S/A (DASA): collaborator

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

UB-612 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gray Heppner

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 24, 2020
• Study Start: February 1, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share