Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine
NCT ID: NCT05293665
Last Updated: 2022-10-14
Study Results
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Basic Information
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UNKNOWN
PHASE3
944 participants
INTERVENTIONAL
2022-03-16
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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double-blind UB-612 boost of ChAdOx1-S
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.
UB-612
UB-612 (100µg), 0.5mL suspension, intramuscular injection
double-blind ChAdOx1-S boost
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.
ChAdOx1-S vaccine
ChAdOx1-S vaccine, 0.5 mL suspension with approximately 5.0 × 10˄10 viral particles, intramuscular injection
double-blind UB-612 boost of BNT162b2
A single injection of UB-612 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2
UB-612
UB-612 (100µg), 0.5mL suspension, intramuscular injection
double-blind BNT162b2 boost
A single injection of BNT162b2 on Day 1 in a double-blinded fashion in subjects who completed the primary immunization series with BNT162b2.
BNT162b2 vaccine
BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection
double-blind UB-612 boost of Sinopharm BIBP
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.
UB-612
UB-612 (100µg), 0.5mL suspension, intramuscular injection
double-blind Sinopharm BIBP
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.
Sinopharm BIBP
Sinopharm BIBP COVID-19 vaccine, 0.5mL (4µg) suspension, intramuscular injection
open-label UB-612 boost of BNT162b2
A single injection of UB-612 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
UB-612
UB-612 (100µg), 0.5mL suspension, intramuscular injection
open-label BNT162b2 boost
A single injection of BNT162b2 on Day 1 in an open-label fashion in subjects who completed the primary immunization series with BNT162b2.
BNT162b2 vaccine
BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection
Interventions
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UB-612
UB-612 (100µg), 0.5mL suspension, intramuscular injection
BNT162b2 vaccine
BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection
ChAdOx1-S vaccine
ChAdOx1-S vaccine, 0.5 mL suspension with approximately 5.0 × 10˄10 viral particles, intramuscular injection
Sinopharm BIBP
Sinopharm BIBP COVID-19 vaccine, 0.5mL (4µg) suspension, intramuscular injection
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. 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.
5. Female subjects of non-childbearing potential may be enrolled.
6. 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.
7. For WOCBP, a serum or urine pregnancy test must be negative at Screening and on the day of study product injection.
8. Must be able to read, understand, and complete questionnaires and diary entries.
9. Plans to reside within study area for the duration of the study.
10. Able to comply with study procedures for the full duration of the study, in the opinion of the investigator.
Exclusion Criteria
2. Receipt of a booster COVID-19 vaccination in addition to the primary vaccine series.
3. 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.
4. Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity.
5. Prior history of pericarditis or myocarditis of any etiology.
6. Prior history of thrombosis of major vessels, including cerebrovascular or splanchnic thrombosis or of thrombosis with thrombocytopenia syndrome
7. History of anaphylaxis (vaccine related or not).
8. Chronic kidney disease with dialysis.
9. 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.
10. Receipt of any cytotoxic or immunosuppressive drug or biologics six (6) months prior to Day 1 visit.
11. Receipt of any investigational drug within six (6) months prior to Day 1 visit.
12. 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.
13. 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.
14. 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.
15. Immunocompromised state (weakened immune system) from solid organ transplant, immunosuppressive or immunodeficient state, autoimmune diseases, asplenia and, recurrent severe infections.
16. Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers.
17. Pregnant or breastfeeding female, or female who intends to become pregnant during the study period.
18. Administration of immunoglobulins and/or any blood products within the 120 days preceding Day 1 or planned administration during the study period.
19. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
20. Bilateral tattoos or scars at the deltoid sites of intramuscular (IM) injection that would obscure examination of injection site reactions.
21. 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.
22. 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.
23. Grade 2 or higher hypertension (systolic \>160 mm Hg and/or diastolic \>100 mm Hg).
24. 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.
16 Years
ALL
Yes
Sponsors
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Syneos Health
OTHER
Coalition for Epidemic Preparedness Innovations
OTHER
Vaxxinity, Inc.
INDUSTRY
Responsible Party
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Locations
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PanAmerican Clinical Research
Brownsville, Texas, United States
Cevaxin David
David, , Panama
Cevaxin 24 de Dieciembre
Panama City, , Panama
Cevaxin The Panama Clinic
Panama City, , Panama
Health Index Multispecialty
Bacoor, , Philippines
Iloilo Doctors Hospital
Iloilo City, , Philippines
St Pauls Hospital Iloilo City
Iloilo City, , Philippines
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Vaxxinity Homepage
Other Identifiers
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U1111-1276-9528
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000088-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UB-612-305
Identifier Type: -
Identifier Source: org_study_id
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