> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-and-immunogenicity-of-booster-61bfffa3-cc41-4833-82bf-65eeef229ffc > Record changed: 2026-10-13 # A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19 NCT05197153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Participants 804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Lead sponsor Medigen Vaccine Biologics Corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Start date 2022-01-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Title and summary **Summary** The purpose of this study is to assess the safety, tolerability, and immunogenicity of booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include: \* The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up). \* The treatment will include 1 booster dose only. \* The visit frequency will be 6 on-site visits and 1 phone visit. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Short title** A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Official title** A Phase II, Prospective, Randomized, Observer-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Heterologous Booster Dose With AZD1222, mRNA-1273, or MVC-COV1901 COVID-19 Vaccine in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Dates **Completion date** 2022-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **First posted** 2022-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Registry last updated** 2023-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Primary completion date** 2022-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Start date** 2022-01-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Size and sites **Actual participants** 804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Participants** 804 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Lead sponsor** Medigen Vaccine Biologics Corp. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Identifiers **Registry ID** NCT05197153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **ClinicalTrials.gov ID** NCT05197153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Outcomes ### Primary outcomes 1. Incidence of Adverse Events from Day 1 to 28 Timeframe: Day1 to 28 days after vaccination To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose. \* Solicited local adverse events (AEs) (up to 7 days after injection of booster dose) \* Solicited systemic AEs (up to 7 days after injection of booster dose) \* Unsolicited AEs (up to 28 days after injection of booster dose) \* AE of special interest (AESI) \* Vaccine-associated enhanced disease (VAED) \* Serious adverse event (SAE) 2. Primary Immunogenicity-1 Timeframe: Day1 to Day 29 To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT 3. Primary Immunogenicity-2 Timeframe: Day1 to Day 29 To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • Seroconversion rate (SCR) 4. Primary Immunogenicity-3 Timeframe: Day1 to Day 29 To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT ratio 5. Primary Immunogenicity-4 Timeframe: Day1 to Day 29 To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • Seroresponse rate ### Secondary outcomes 1. Incidence of Adverse Events from Day 1 to 181 Timeframe: Day 1 to Day 181 To measure the incidence of adverse event throughout the whole study period. \* ≥ Grade 3 AE \* AESI \* VAED \* SAE 2. Secondary Immunogenicity (Humoral)-1 Timeframe: Day 1 to Day 181 To evaluate the immunogenicity in terms of Anti-spike IgG • GMT 3. Secondary Immunogenicity (Humoral)-2 Timeframe: Day 1 to Day 181 To evaluate the immunogenicity in terms of Anti-spike IgG • SCR 4. Secondary Immunogenicity (Humoral)-3 Timeframe: Day 1 to Day 181 To evaluate the immunogenicity in terms of Anti-spike IgG • GMT ratio 5. Secondary Immunogenicity (Cellular) Timeframe: Day 1 to Day 15 To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Male or female participants aged ≥ 18 years at randomization. 2. Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study. 3. Documented to have received two homologous doses of AZD1222, mRNA-1273, or MVC-COV1901 vaccine, with the latest dose between 150 and 365 days prior to randomization, with an interval between the two homologous doses of ≥ 4 weeks to ≤ 12 weeks, and did not receive any other investigational or approved COVID-19 vaccines 4. Female participants must: 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal; 2. Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the injection of study intervention. Acceptable forms include: i.Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.Have a negative pregnancy test 5. Participant is willing and able to comply with all required study visits and follow-up required by this protocol. 6. Participant, and the participant's legal representative if applicable, must understand the procedures of the study and provide written informed consent. ### Exclusion criteria 1. Pregnant or breast feeding or have plan to become pregnant in 30 days after the administration of study intervention. 2. Employees at the investigator's site, of the Sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study. 3. Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study intervention. 4. Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to vaccination of study intervention. 5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the vaccination of study intervention. 6. Currently receiving or anticipated to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the vaccination of study intervention. 7. Currently receiving or anticipated to receive treatment with tumor necrosis factor (TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the vaccination of study intervention. 8. Major surgery or any radiation therapy within 12 weeks prior to the vaccination of study intervention. 9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. 10. A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator). 11. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. 12. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, capillary leak syndrome, myocarditis, or pericarditis 13. Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant. 14. Documented SARS-CoV1 or 2 infection prior to the study intervention. 15. Participant with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the AZD1222, mRNA-1273 or MVC-COV1901. 16. Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the vaccination of study intervention. 17. Any condition that is a contraindication to study intervention based on the judgement of the investigator Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Sites - Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, Taiwan - National Taiwan University HospitalTaipei, Taiwan - Taipei Municipal Wan Fang HospitalTaipei, Taiwan - Taipei Veteran General HospitalTaipei, Taiwan Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## References - PubMed 37080829 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37080829/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05197153) ## Related records ### Drugs (3) - [Elasomeran](https://trialight.com/data/asset/elasomeran-7d917cbd-1f45-43e8-a188-fd6dec78e983.md) - [Etanercept](https://trialight.com/data/asset/etanercept-b317b90d-f8fa-4b94-a6a2-12f14534f4a1.md) - [Sodium chloride](https://trialight.com/data/asset/sodium-chloride-a67c33bc-45ef-42e4-8022-d121f0a86585.md) ### Collaborators (1) - Coalition for Epidemic Preparedness Innovations ### Lead sponsors (1) - [Medigen Vaccine Biologics Corp.](https://trialight.com/data/company/medigen-vaccine-biologics-corp-c79c230d-3a49-49c8-b8e7-29b2207902a4.md) ### Targets (1) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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