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Immunogenicity of COVID-19 Vaccine on Heterologous Schedule

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ClinicalTrials.gov Identifier: NCT05054621
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Covid-19 Vaccine Immunogenicity Reactogenicity Healthy Biological: Heterologous prime-boost schedule with AZD1222 and MVC-COV1901 Biological: Homologous prime-boost schedule with two doses of AZD1222 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Single-blind, Randomized Study to Evaluate the Immunogenicity of Heterologous Prime-boost COVID-19 Vaccine Schedule
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
Experimental: Heterologous group
1st dose AZD1222, 2nd dose MVC-COV1901
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.

Active Comparator: Homologous group (control)
1st dose AZD1222, 2nd dose AZD1222
Biological: 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.




Primary Outcome Measures :
  1. Immunogenicity: Neutralizing antibody against SARS-CoV-2 [ Time Frame: Day 28 after booster dose ]
    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


Secondary Outcome Measures :
  1. Immunogenicity:Anti-SARS-CoV-2 Spike antibody [ Time Frame: base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine ]
    Further determination of Anti-SARS-CoV-2 Spike antibodies in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines

  2. Adverse events [ Time Frame: through study completion, 6 months. ]
    To evaluate the safety of heterologous & homologous prime-boost immunization of COVID-19 vaccines

  3. Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody [ Time Frame: base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine ]
    Further determination of immunogenicity of Anti-SARS-CoV-2 Nucleocapsid in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.

  4. Immunogenicity: T cell immunity [ Time Frame: baseline (Day 0) and during the. intervention at day 10 and 28 after booster dose of vaccine ]
    Further determination of T cellular immune responses by ELISpot in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054621


Contacts
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Contact: Chih-Jung Chen, MD +886975365938 james.ped@gmail.com

Locations
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Taiwan
ChangGungMH Recruiting
Taoyuan, Taiwan, 333
Contact: Chih-Jung Chen, MD    +886975365938    chinjung@cgmh.org.tw   
Principal Investigator: ChinJung Chen, MD         
Sub-Investigator: KuanYing Huang, MD         
Sub-Investigator: YhuChering Huang, MD         
Sub-Investigator: ChengHsun Chiu, MD         
Sub-Investigator: LanYan Yang, PhD         
Sub-Investigator: ShinRu Shih, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT05054621    
Other Study ID Numbers: Heterologous_AZ_Medigen
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases