Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05054621
Other study ID # Heterologous_AZ_Medigen
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 15, 2021
Est. completion date August 31, 2022

Study information

Verified date August 2021
Source Chang Gung Memorial Hospital
Contact Chih-Jung Chen, MD
Phone +886975365938
Email james.ped@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, single blinded randomized homologous/heterologous prime-boost vaccine clinical study, designed to assess the immunogenicity of heterologous prime-boost immunization with AZD1222 and MVC-COV1901 in adults. Participants will be healthy adults at the age of 20-70 years who have had their first dose of COVID-19 vaccine, AZD1222. All eligible participants of 2 prime-boost interval strata (28 to 42, 56 to 70 days) will be 1:1 randomly assigned to receive a single dose of either: - Homologous group: Intramuscular injection the same vaccine as their prime dose AZD1222 - Heterologous group: Medigen COVID-19 vaccine MVC-COV1901. The treatment phase of this study will be conducted in a single-blind fashion such that the subject will not know the identity of the subjects' study treatment assignment. After receiving the treatment, the participants will remain on study for 168 days following the boost vaccination. For the study primary objective, immunogenicity will be assessed during the duration of the study, including serologic neutralizing antibody titer against SARS-CoV-2, serological quantification of binding antibody to SARS-CoV-2 antigen, SARS-CoV-2 antigen specific B cell and T cell frequencies and cytokine levels. And Safety will be assessed during the duration of the study as follows: - Solicited adverse events (AEs; local and systemic) will be assessed for 7 days following each vaccination (Day 0 through Day 7 for the boost vaccination). - Unsolicited AEs will be recorded for 28 days following the boost vaccination. - Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 168. - Adverse events of special interest (AESIs) will be recorded from the boost vaccination through Day 168. This study is going to be conducted in a single medical center in Taiwan. An appropriate number of participants will be screened to achieve approximately 44 evaluable participants for each group. Participants in each group will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: 1. Participant is willing and able to give written informed consent for participation in the trial. 2. Male or Female, aged from 20 to 70 years 3. Has received one dose of the AZD1222 within 28-70 days before randomization. Evidence of this will be gathered from medical history and/or medical records including the COVID-19 vaccine registration yellow card. 4. Female participant 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 on enrolment continuously until 90 days after boost immunization 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. In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: - The participant may not enter the trial if ANY of the following apply: 1. Previous receipt of two or more COVID-19 vaccine doses 2. History of anaphylaxis, severe allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine). This includes latex and polyethylene glycol/macrogol (PEG) 3. Pregnancy, lactation or willingness/intention to become pregnant within 3 months post boost vaccine 4. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrolment. 5. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. 6. Suspected or known current alcohol or drug dependency. 7. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. 8. Insufficient level of language to undertake all study requirements in opinion of the Investigators. 9. Known HIV antibody positive.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Heterologous prime-boost schedule with AZD1222 and MVC-COV1901
Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.
Homologous prime-boost schedule with two doses of AZD1222
Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.

Locations

Country Name City State
Taiwan ChangGungMH Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity: Neutralizing antibody against SARS-CoV-2 To determine if the immune response to heterologous prime-boost immunization with ChAdOx1 nCOV-19 (AZD1222) and MVC-COV1901 is non-inferior to homologous prime-boost immunization with ChAdOx1 nCOV-19, in enrolled adult participants Day 28 after booster dose
Secondary Immunogenicity:Anti-SARS-CoV-2 Spike antibody Further determination of Anti-SARS-CoV-2 Spike antibodies in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine
Secondary Adverse events To evaluate the safety of heterologous & homologous prime-boost immunization of COVID-19 vaccines through study completion, 6 months.
Secondary Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody Further determination of immunogenicity of Anti-SARS-CoV-2 Nucleocapsid in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines. base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine
Secondary Immunogenicity: T cell immunity Further determination of T cellular immune responses by ELISpot in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines. baseline (Day 0) and during the. intervention at day 10 and 28 after booster dose of vaccine
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1