A Phase 3 Multi-Center International, Randomized, Active-Controlled Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost with UB-612 Vaccine

PHRR220725-004899

Unspecified

2022-CT0683

A Phase 3 Multi-Center International, Randomized, Active-Controlled Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost with UB-612 Vaccine

This is a multicenter, international, randomized, active-controlled platform study with each sub-study designed to randomize subjects to receive a single injection with UB-612 or a comparator COVID-19 vaccines in 1:1 ratio. A double-blinded or an open label sub-studies were designed for BNT162b2 and ChAdOx1-S, while Sinopharm has only a double-blinded sub-study.

Subjects 16 years and older with completed primary immunization at least 3 months (Pfizer at least 5 months) prior to study vaccine injection will be randomized 1:1 into each treatment, stratified by age group (16-64 and 65+ years), gender, N-protein seropositivity, or the time since last dose of primary immunization. Participants will be screened at baseline for antibodies to the nucleoprotein (N) of SARS-CoV-2; the number of seropositive participants will be capped at 10% in each sub-study.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Communicable diseases
Start Date Duration in Months Target Completion Date Actual Completion Date
2022-08-15 13 2023-09-15 2023-12-31

Pending

The sites are scheduled to be initiated next month.

Institution Classification Region LTO #
Vaxxinity Inc. Private Business United States of America NA
Institution Classification Region LTO #
Syneos Health Philippines Inc. Private Business NCR 3000006160343
Institution Region
Vaxxinity Inc. United States of America
Name E-Mail Institution and Institution Address
Ulo Palm, MD, PhD, MBA Ulo@vaxxinity.com Vaxxinity, Inc. 1717 Main St, Suite 3388 Dallas TX 75201
Name E-Mail Institution and Institution Address
Sasha Rumyantsev, MD, PhD, MBA sasha@vaxxinity.com Vaxxinity, Inc. 1717 Main St, Suite 3388 Dallas TX 75201
Name Expertise Affiliation
Anjuli May Jaen Pulmonary Medicine Iloilo Doctor's Hospital
Dovie Lallaine Borra Ygpuarra Adult Diseases St Pauls Hospital Iloilo
Edison Reyes Alberto, MD Pediatric Medicine Health Index Multispecialty Clinic
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Iloilo Doctor's Hospital Iloilo Doctors Hospital West Visayas State University Unified Biomedical Research Ethics Review Committee Anjuli May Jaen Pulmonary Medicine
St Pauls Hospital Iloilo St. Pauls Hospital of Iloilo St. Paul’s Hospital Iloilo – Institutional Ethics Review Board Dovie Lallaine Borra Ygpuarra Adult Diseases
Health Index Multispecialty Clinic Health Index Multispecialty Clinic UERMMMC Research Institute for the Health Sciences Ethics Review Committee Edison Reyes Alberto, MD Pediatric Medicine
Project Location Institutional Ethics Review Board
Iloilo Doctor's Hospital West Visayas State University Unified Biomedical Research Ethics Review Committee
St Pauls Hospital Iloilo St. Paul’s Hospital Iloilo – Institutional Ethics Review Board
Health Index Multispecialty Clinic UERMMMC Research Institute for the Health Sciences Ethics Review Committee

Clinical Trial

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COVID 19

 

The primary safety endpoints in this study will be:

Solicited adverse events (AEs): Day 1-8 after immunization

Unsolicited AEs: Day 1- 29 days after immunization

Serious adverse events, and medically attended adverse events, and adverse events of special interest: throughout the study.

The co-primary immunogenicity endpoints are based on SARS-CoV-2 neutralizing antibody titers tested in Vero cells using replicating virus (prototype Wuhan strain):

  • Geometric mean antibody titer ratio (GMR) at Day 29

Proportion of subjects with ≥4‑fold antibody titer rise from Day 1 to Day 29 (seroconversion rate, SCR)

SARS-CoV-2 neutralizing antibody titers measured in Vero cells using replicating virus Omicron variant

  • Neutralizing antibody geometric mean titer ratio (GMR) at Day 29 post-boost
  • Proportion of subjects with ≥4‑fold rise from before study product injection to Day 29 post-boost (seroresponse rate)

SARS-CoV-2 neutralizing antibody titers measured in Vero cells using replicating virus Wuhan and Omicron variant

  • Area under the curve (AUC) of neutralizing antibody response by treatment group and virus variants from Day 15 to Month 12
  • Neutralizing antibody geometric mean titer (GMT) on Days 15, 29, and Months 6 and 12 post-boost
  • Geometric mean fold increase (GMFI) in neutralizing antibodies titers from before study product injection on Day 1 to Day 15, Day 29, and Months 6 and 12 post-boost
  • Proportion of subjects with ≥4‑fold rise of neutralizing antibodies from before study product injection to Days 15 and 29, and Months 6 and 12 post-boost

Distribution of neutralizing antibody titers determined on Day 29 and Month 6 and 12 post-boost, displayed as reverse cumulative distribution curves by the treatment group and virus variant

SARS-CoV-2 immunoglobulin G (IgG) antibody titers measured by direct S1-RBD binding ELISA

  • IgG antibody GMT on Days 15, 29, and Months 6 and 12 post-boost
  • GMFI in of IgG antibodies titers from before study product injection on Day 1 to Day 15 and Day 29, and Months 6 and 12 post-boost
  • Proportion of subjects with ≥4‑fold rise of IgG antibodies from before study product injection to Days 15 and 29, and Months 6 and 12 post-boost
  • Distribution of IgG antibody titers determined on Day 29 and Months 6 and 12 post-boost, displayed as reverse cumulative distribution curves by the treatment group and virus variant

Area under the curve (AUC) of IgG antibody response by the treatment group and the virus variant from Day 15 to Month 12 post-boost

Pending

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2022-06-30

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No result found.

782

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Inclusion Criteria

  • Males or females of childbearing potential, 16 years or older, willing to adhere to practice abstinence or use acceptable methods of contraception. Females subject of non-childbearing potential may be enrolled.
  • Documented completed primary series with a comparator vaccine with the last dose administered at least 3 months (Pfizer at least 5 months) prior to Day 1 of the study.
  • Healthy or with stable pre-existing medical condition

 

Exclusion Criteria

  • Known history of COVID-19 or SARS-CoV-2 infection.
  • Receipt of a booster COVID-19 vaccination in addition to the primary vaccine series
  • Presence of COVID-19 symptoms within 1 week before study Day 1

Interventional

UB 612

UB-612 vaccine product contains a combined recombinant SARS-CoV-2 subunit fusion protein (S1-RBD-sFc) and rationally selected synthetic peptides (Th/CTL) as core immunogens, which are mixed with a proprietary CpG oligonucleotide (CpG1) excipient in solution and formulated with Adju-Phos® to form a wet gel suspension. The S1-RBD-sFc fusion protein is produced in CHO cells; the Th and CTL epitope peptides are selected from M, S2 and N regions; and the UBITh®1a is a T helper peptide adapted from MVF protein.

The S1-RBD-sFc fusion protein includes both linear and conformation epitopes, inducing high binding antibodies to the RBD, inhibits its binding to the hACE2 receptor and neutralizes replicating virus in CPE-based neutralization assays. The Th and CTL peptides are promiscuous and highly potent epitopes that are expected to bind to human MHC I and II for induction of memory recall and T cell activation and effector functions.

The vaccine components are combined in the presence of CpG as an excipient and added to aluminum phosphate (Adju-Phos®) as an adjuvant for production of the final UB-612 vaccine. UB-612 is supplied as a sterile Adju-Phos® suspension in multi-dose glass vials for a 0.5 mL IM injection.

None

Method of Allocation

Randomized

Masking or Blinding

Open Label

Masking Details

Unspecified

Control

Unspecified

Assignment

Single

Phase

Phase III

Purpose of the Study

The current platform protocol is designed to determine the safety and immunizing activity of a booster dose of 100 µg UB-612 in patients who have received a different vaccine 3 months or more before the study start. 

Detailed purpose of the study

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Plan to Share IPD

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IPD Description

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Date of posting of result summaries

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Date of the first journal publication of results

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URL hyperlinks related to results and publications

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URL link to protocol files(s) with version and data

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Baseline Characteristics

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Participant Flow

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Adverse Events

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Outcome Measures

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Brief Summary

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Utilization Utilization Info
Publication

NA

Oral Presentation

NA

Drug Literature

NA

Posters

NA

Others

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