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COVID-19 VaccinesPhase 3NCT05293665

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

A Phase 3 study testing UB-612, BNT162b2 vaccine and ChAdOx1-S vaccine in people with COVID-19 Vaccines, run by Vaxxinity, Inc. at 7 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccines
What is being tested?
UB-612, BNT162b2 vaccine and ChAdOx1-S vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
944 participants
Where
7 sitesin 3 countries
Study dates
16 Mar 2022to Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Immunocompromised state (weakened immune system) from solid organ transplant, immunosuppressive or immunodeficient state, autoimmune diseases, asplenia and, recurrent severe infections.
  • Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers.
  • Pregnant or breastfeeding female, or female who intends to become pregnant during the study period.
  • Administration of immunoglobulins and/or any blood products within the 120 days preceding Day 1 or planned administration during the study period.
  • Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  • Bilateral tattoos or scars at the deltoid sites of intramuscular (IM) injection that would obscure examination of injection site reactions.
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the Principal Investigator or his or her representative physician, affects the subject's ability to understand and cooperate with all study protocol requirements.
  • 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.
  • Grade 2 or higher hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg).
  • Any other condition that, in the opinion of the Principal Investigator or his/her representative physician, could put the safety/rights of potential subjects at risk or prevent them from complying with the study protocol.

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Panama3 sites

  • Cevaxin David

    David

  • Cevaxin 24 de Dieciembre

    Panama City

  • Cevaxin The Panama Clinic

    Panama City

Other trials in Panama

Philippines3 sites

  • Health Index Multispecialty

    Bacoor

  • Iloilo Doctors Hospital

    Iloilo City

  • St Pauls Hospital Iloilo City

    Iloilo City

Other trials in Philippines

United States1 site

  • PanAmerican Clinical Research

    Brownsville, Texas, 78521

Other trials in United States

About this study

Official title: 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 vaccine in 1:1 ratio.

Read the detailed description

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 (i.e., Day 1). The randomized, active-controlled multicenter study sponsored by Vaxxinity will be conducted in several countries under a master platform protocol outlining common objectives, endpoints, population, study design, and data analysis. The platform protocol is designed for multiple sub-studies to be implemented at any time, each independently addressing the same set of scientific questions aimed to evaluate the immune responses after a booster injection with UB-612 vaccine candidate and a particular comparator COVID-19 vaccine product.

Being tested
UB-612, BNT162b2 vaccine, ChAdOx1-S vaccine, Sinopharm BIBP
Keywords
COVID-19, SARS-CoV-2, peptide, vaccine, subunit, protein
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UB-612Biological

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

  • BNT162b2 vaccineBiological

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

  • ChAdOx1-S vaccineBiological

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

  • Sinopharm BIBPBiological

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

Study groups in NCT05293665
Study groupRoleWhat they receive
double-blind UB-612 boost of ChAdOx1-SExperimentalA single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.
Receives: Biological: UB-612
double-blind ChAdOx1-S boostActive comparatorA single injection of ChAdOx1-S on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with ChAdOx1-S.
Receives: Biological: ChAdOx1-S vaccine
double-blind UB-612 boost of BNT162b2ExperimentalA single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2
Receives: Biological: UB-612
double-blind BNT162b2 boostActive comparatorA single injection of BNT162b2 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2.
Receives: Biological: BNT162b2 vaccine
double-blind UB-612 boost of Sinopharm BIBPExperimentalA single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.
Receives: Biological: UB-612
double-blind Sinopharm BIBPActive comparatorA single injection of Sinopharm BIBP on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with Sinopharm BIBP.
Receives: Biological: Sinopharm BIBP
open-label UB-612 boost of BNT162b2ExperimentalA single injection of UB-612 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
Receives: Biological: UB-612
open-label BNT162b2 boostActive comparatorA single injection of BNT162b2 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
Receives: Biological: BNT162b2 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of solicited local or systemic reactions

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

    Measured: Day 8 after injection

  2. Presence of unsolicited local or systemic reactions

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

    Measured: Day 29 after injection

  3. Presence of serious adverse events

    SAE are reported through the study

    Measured: Day 387 after injection

  4. Presence of medically attended adverse events

    AE that leads to an unscheduled visit

    Measured: Day 387 after injection

  5. Presence of adverse events of special interest

    AESI are reported throughout the study

    Measured: Day 387 after injection

  6. 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

    Measured: Day 29 after injection

Secondary outcomes (13)

  1. Boost in neutralizing antibody titers against Omicron strain at Day 29

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

    Measured: Day 29 after injection

  2. Responders determined on Day 29 (Wuhan)

    Proportion of subjects with ≥4-fold antibody titer rise from Day 1 to Day 29

    Measured: Day 1 to 29 after injection

  3. Responders determined on Day 29 (Omicron)

    Proportion of subjects with ≥4-fold antibody titer rise from Day 1 to Day 29

    Measured: Day 1 to 29 after injection

  4. Kinetics and duration of antibody response - Responders via neutralizing antibodies

    Proportion of subjects with ≥4-fold antibody titer rise over the life of trial measured by neutralizing antibodies determined using replicating or pseudotyped virus

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

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

    Proportion of subjects with ≥4-fold antibody titer rise over the life of trial measured by IgG antibodies titers measured by direct S1-RBD binding ELISA

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

  6. Kinetics and duration of antibody response - GMFI via neutralizing antibodies

    Geometric Mean Fold Increase of neutralizing antibodies determined using replicating or pseudotyped virus

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

  7. Kinetics and duration of antibody response - GMFI via binding to S1-RBD

    Geometric Mean Fold Increase of IgG antibodies titers measured by direct S1-RBD binding ELISA

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

  8. Kinetics and duration of antibody response - AUC via neutralizing antibodies

    Area under the curve (AUC) by treatment group and virus variants calculated from neutralizing antibody response determined using replicating or pseudotyped virus

    Measured: Day 15 to Month 12

  9. Kinetics and duration of antibody response - AUC via binding to S1-RBD

    Area under the curve (AUC) by treatment group and virus variants calculated from IgG antibody response measured by direct S1-RBD binding ELISA

    Measured: Day 15 to Month 12

  10. Kinetics and duration of antibody response - GMT via neutralizing antibodies

    Geometric Mean Titers measured by neutralizing antibody response by treatment group and virus variants

    Measured: Days 15, 29, and Months 6 and 12

  11. Kinetics and duration of antibody response - GMT via binding to S1-RBD

    Geometric Mean Titers measured by IgG antibody response measured by direct S1-RBD binding ELISA

    Measured: Days 15, 29, and Months 6 and 12

  12. Kinetics and duration of antibody response - Reverse Cumulative Distribution Curve via neutralizing antibodies

    Distribution of neutralizing antibody titers displayed as reverse cumulative distribution curves by treatment group and virus variants measured by neutralizing antibody response

    Measured: Day 29 and Month 6 and 12

  13. Kinetics and duration of antibody response - Reverse Cumulative Distribution Curve via binding to S1-RBD

    Distribution of IgG antibody titers displayed as reverse cumulative distribution curves by the treatment group and virus variant measured IgG antibody response measured by direct S1-RBD binding ELISA

    Measured: Day 29 and Month 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start16 Mar 2022
  3. Primary completionNov 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Platform trial with multiple sub-studies. Each sub-study has two treatment arms: active comparator and IMP.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05293665
Sponsor's protocol ID
UB-612-305
Other IDs
U1111-1276-9528, 2022-000088-38
Status last verified
Oct 2022
First submitted
21 Mar 2022
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34480858

  • 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.

    PubMed 35062747

  • 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.

    PubMed 32234451

  • 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.

    PubMed 31986257

  • 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.

    PubMed 1808876

  • 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.

    PubMed 40727012

  • 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.

    PubMed 37079651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UB-612, BNT162b2 vaccine and ChAdOx1-S vaccine in people with COVID-19 Vaccines, run by Vaxxinity, Inc. at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Panama, Philippines, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of solicited local or systemic reactions (time frame: Day 8 after injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05293665, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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