Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine

NCT05293665 | Unknown Phase 3 DMC FDA Drug

• 3 other identifiers: UB-612-305U1111-1276-95282022-000088-38
• Study Type: interventional
• Target: 944
• Locations: 3 countries
• Sites: 7

Brief Summary

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 vaccine in 1:1 ratio.

Conditions

COVID-19 Vaccines

Keywords

COVID-19; SARS-CoV-2; peptide; vaccine; subunit; protein

Outcome Measures

Primary Outcomes (6)

• Presence of solicited local or systemic reactions

  Local: pain, tenderness, erythema, induration, pruritis. Systemic: Nausea, diarrhea, headache, fatigue, myalgia, chills, joint pain, rash

  Day 8 after injection

• Presence of unsolicited local or systemic reactions

  Any AE reported by the subject that is not specified as a solicited

  Day 29 after injection

• Presence of serious adverse events

  SAE are reported through the study

  Day 387 after injection

• Presence of medically attended adverse events

  AE that leads to an unscheduled visit

  Day 387 after injection

• Presence of adverse events of special interest

  AESI are reported throughout the study

  Day 387 after injection

• Boost in neutralizing antibody titers against Wuhan strain at Day 29

  Geometric Mean Titer Ratios of neutralizing antibodies at Day 29 determined using replicating or pseudotyped virus

  Day 29 after injection

Secondary Outcomes (13)

• Boost in neutralizing antibody titers against Omicron strain at Day 29

  Day 29 after injection

• Responders determined on Day 29 (Wuhan)

  Day 1 to 29 after injection

• Responders determined on Day 29 (Omicron)

  Day 1 to 29 after injection

• Kinetics and duration of antibody response - Responders via neutralizing antibodies

  Day 1 to Day 15, Day 29, and Months 6 and 12

• Kinetics and duration of antibody response - Responders via binding to S1-RBD

  Day 1 to Day 15, Day 29, and Months 6 and 12

Other Outcomes (5)

• Ability to boost cellular immunity

  Days 1, 15 and 29, and Months 6 and 12

• Ability to boost humoral immunity (non-neutralizing)

  Day 1 and Day 29

• Ability to boost humoral immunity (neutralizing) against additional variant - GMT via neutralizing antibodies

  Day 1 and Day 29

Study Arms (8)

double-blind UB-612 boost of ChAdOx1-S

EXPERIMENTAL

A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.

Biological: UB-612

double-blind ChAdOx1-S boost

ACTIVE COMPARATOR

A single injection of ChAdOx1-S on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.

Biological: ChAdOx1-S vaccine

double-blind UB-612 boost of BNT162b2

EXPERIMENTAL

A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2

Biological: UB-612

double-blind BNT162b2 boost

ACTIVE COMPARATOR

A single injection of BNT162b2 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2.

Biological: BNT162b2 vaccine

double-blind UB-612 boost of Sinopharm BIBP

EXPERIMENTAL

A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.

Biological: UB-612

double-blind Sinopharm BIBP

ACTIVE COMPARATOR

A single injection of Sinopharm BIBP on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.

Biological: Sinopharm BIBP

open-label UB-612 boost of BNT162b2

EXPERIMENTAL

A single injection of UB-612 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.

Biological: UB-612

open-label BNT162b2 boost

ACTIVE COMPARATOR

A single injection of BNT162b2 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.

Biological: BNT162b2 vaccine

Interventions

UB-612 BIOLOGICAL

UB-612 (100µg), 0.5mL suspension, intramuscular injection

double-blind UB-612 boost of BNT162b2; double-blind UB-612 boost of ChAdOx1-S; double-blind UB-612 boost of Sinopharm BIBP; open-label UB-612 boost of BNT162b2

BNT162b2 vaccine BIOLOGICAL

BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection

double-blind BNT162b2 boost; open-label BNT162b2 boost

ChAdOx1-S vaccine BIOLOGICAL

ChAdOx1-S vaccine, 0.5 mL suspension with approximately 5.0 × 10˄10 viral particles, intramuscular injection

double-blind ChAdOx1-S boost

Sinopharm BIBP BIOLOGICAL

Sinopharm BIBP COVID-19 vaccine, 0.5mL (4µg) suspension, intramuscular injection

double-blind Sinopharm BIBP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent/assent after reading the consent/assent form and having adequate opportunity to discuss the study with an investigator or designee.
• Documented fully vaccinated with primary series of a comparator vaccine. Primary immunization is defined as 2 doses spaced approximately 3-16 weeks apart. The last dose of the previous vaccine must have been administered at least three (3) months (Pfizer at least (5) months) prior to Day 1, taking into consideration the current local and national regulations, and according to details related to individual comparators provided in relevant sub-studies. Documentation, such as the National Health Service (NHS) COVID Pass, United States Centers for Disease Control vaccine card, or equivalent documentation (e.g., medical records, vaccine passport; in accordance with local approved vaccination record documentation) will be required for proof of vaccination, vaccine manufacturer and vaccination dates.
• No clinically significant health problems that could affect the safety of the subject, as determined by the investigator by medical history, laboratory tests and physical examination. May have a stable pre-existing medical condition that did not require significant change in medication or hospitalization in 3 months before screening or which, in the judgement of the investigator is unlikely to require a significant change in therapy or hospitalization for worsening disease in the 3 months after Day 1.
• Negative SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) or antigen test within 24-48 hours prior to receipt of injections on Day 1.
• Female subjects of non-childbearing potential may be enrolled.
• Males and WOCBP, 16 years or older, may be enrolled in the study if they are willing to practice abstinence from sexual intercourse or are willing to use acceptable methods of contraception as described below, from the time of signing the informed consent/assent during the screening period through study product injection on Day 1 and until completion of Day 29. Acceptable methods of contraception should be consistent with local availability/regulations regarding the use of contraceptive methods for those participating in clinical trials.
• For WOCBP, a serum or urine pregnancy test must be negative at Screening and on the day of study product injection.
• Must be able to read, understand, and complete questionnaires and diary entries.
• Plans to reside within study area for the duration of the study.
• Able to comply with study procedures for the full duration of the study, in the opinion of the investigator.

You may not qualify if:

• Known history of COVID-19 or SARS-CoV-2 infection within six (6) months prior to vaccination (Day 1).
• Receipt of a booster COVID-19 vaccination in addition to the primary vaccine series.
• Presence of fever \>100.4°F/38°C or other signs or symptoms of COVID-19 (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) within 1 week prior to Day 1 study product injection. Screening and/or study product injection may be rescheduled at the discretion of the investigator.
• Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity.
• Prior history of pericarditis or myocarditis of any etiology.
• Prior history of thrombosis of major vessels, including cerebrovascular or splanchnic thrombosis or of thrombosis with thrombocytopenia syndrome
• History of anaphylaxis (vaccine related or not).
• Chronic kidney disease with dialysis.
• Receipt of systemic corticosteroids (≥0.5 mg/kg per day of prednisone or equivalent)for ≥7 days is prohibited from 28 days before enrollment through conclusion of the study. Topical, inhaled, intra-nasal, intra-articular or intra-bursal administration of corticosteroids is permitted.
• Receipt of any cytotoxic or immunosuppressive drug or biologics six (6) months prior to Day 1 visit.
• Receipt of any investigational drug within six (6) months prior to Day 1 visit.
• Subject received or plans to receive a live attenuated vaccine or licensed adjuvanted(non-aluminum compound) vaccination within 28 days before or after planned administration of study vaccine (Day 1) or another type of vaccine (including influenza vaccine) within 14 days prior to or after planned administration of study vaccine on Day1 visit.
• Human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) positive; hepatitis C virus (HCV) antibody positive subjects may be tested for RNA and if negative may be enrolled.
• Any Grade 2 or greater clinical or laboratory abnormalities at screening results.
• Grade 1 abnormal clinical or laboratory adverse event screening test results which, according to the investigator, are non-clinically significant would not disqualify a potential subject. Clinical or laboratory screening tests may be repeated once to exclude transient abnormalities.

Sponsors & Collaborators

• Vaxxinity, Inc.: lead
• Syneos Health: collaborator
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (7)

PanAmerican Clinical Research

Brownsville, Texas, 78521, United States

Location

Cevaxin David

David, Panama

Location

Cevaxin 24 de Dieciembre

Panama City, Panama

Location

Cevaxin The Panama Clinic

Panama City, Panama

Location

Health Index Multispecialty

Bacoor, Philippines

Location

Iloilo Doctors Hospital

Iloilo City, Philippines

Location

St Pauls Hospital Iloilo City

Iloilo City, Philippines

Location

Related Publications (7)

• Flaxman A, Marchevsky NG, Jenkin D, Aboagye J, Aley PK, Angus B, Belij-Rammerstorfer S, Bibi S, Bittaye M, Cappuccini F, Cicconi P, Clutterbuck EA, Davies S, Dejnirattisai W, Dold C, Ewer KJ, Folegatti PM, Fowler J, Hill AVS, Kerridge S, Minassian AM, Mongkolsapaya J, Mujadidi YF, Plested E, Ramasamy MN, Robinson H, Sanders H, Sheehan E, Smith H, Snape MD, Song R, Woods D, Screaton G, Gilbert SC, Voysey M, Pollard AJ, Lambe T; Oxford COVID Vaccine Trial group. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002). Lancet. 2021 Sep 11;398(10304):981-990. doi: 10.1016/S0140-6736(21)01699-8. Epub 2021 Sep 1.

  PMID: 34480858 BACKGROUND

• Kanokudom S, Assawakosri S, Suntronwong N, Auphimai C, Nilyanimit P, Vichaiwattana P, Thongmee T, Yorsaeng R, Srimuan D, Thatsanatorn T, Klinfueng S, Sudhinaraset N, Wanlapakorn N, Honsawek S, Poovorawan Y. Safety and Immunogenicity of the Third Booster Dose with Inactivated, Viral Vector, and mRNA COVID-19 Vaccines in Fully Immunized Healthy Adults with Inactivated Vaccine. Vaccines (Basel). 2022 Jan 6;10(1):86. doi: 10.3390/vaccines10010086.

  PMID: 35062747 BACKGROUND

• Petrosillo N, Viceconte G, Ergonul O, Ippolito G, Petersen E. COVID-19, SARS and MERS: are they closely related? Clin Microbiol Infect. 2020 Jun;26(6):729-734. doi: 10.1016/j.cmi.2020.03.026. Epub 2020 Mar 28.

  PMID: 32234451 BACKGROUND

• Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

  PMID: 31986257 BACKGROUND

• Matthes H, Herbst H, Schuppan D, Stallmach A, Milani S, Stein H, Riecken EO. [Distribution of procollagen transcripts in chronic inflammatory bowel diseases using in situ hybridization]. Verh Dtsch Ges Inn Med. 1991;97:12-7. No abstract available. German.

  PMID: 1808876 BACKGROUND

• Rumyantsev A, Wang L, Wang S, Kemp T, Wriggins A, Burks A, Fisher D, Brokke K, Fix A, Hensley S, Lewis M, Zhu R, Wang K, Shasha C, Piccini G, Manenti A, Montomoli E, DeAntonio R, Saez-Llorens X, Chan M, Alberto E, Lallaine Borra MD, Jaen AM, Heppner G, Palm U, Monath TP. Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial. EClinicalMedicine. 2025 Jul 21;86:103349. doi: 10.1016/j.eclinm.2025.103349. eCollection 2025 Aug.

  PMID: 40727012 DERIVED

• Wang CY, Peng WJ, Kuo BS, Ho YH, Wang MS, Yang YT, Chang PY, Shen YH, Hwang KP. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses. PLoS Pathog. 2023 Apr 20;19(4):e1010870. doi: 10.1371/journal.ppat.1010870. eCollection 2023 Apr.

  PMID: 37079651 DERIVED

Related Links

• Vaxxinity Homepage

MeSH Terms

Conditions

COVID-19

Interventions

UB-612 COVID-19 vaccine; BNT162 Vaccine; BIBP COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Platform trial with multiple sub-studies. Each sub-study has two treatment arms: active comparator and IMP.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 24, 2022
• Study Start: March 16, 2022
• Primary Completion: November 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PH (3); US (1); PA (3)