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Immunogenicity of COVID-19 Vaccine on Heterologous Schedule

Primary Purpose

Covid-19, Vaccine, Immunogenicity

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Heterologous prime-boost schedule with AZD1222 and MVC-COV1901

Homologous prime-boost schedule with two doses of AZD1222

About this trial

This is an interventional prevention trial for Covid-19

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participant is willing and able to give written informed consent for participation in the trial.
Male or Female, aged from 20 to 70 years
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.
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.
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:

Previous receipt of two or more COVID-19 vaccine doses
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)
Pregnancy, lactation or willingness/intention to become pregnant within 3 months post boost vaccine
Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrolment.
Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
Suspected or known current alcohol or drug dependency.
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.
Insufficient level of language to undertake all study requirements in opinion of the Investigators.
Known HIV antibody positive.

Sites / Locations

ChangGungMHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heterologous group

Homologous group (control)

Arm Description

1st dose AZD1222, 2nd dose MVC-COV1901

1st dose AZD1222, 2nd dose AZD1222

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Adverse events

To evaluate the safety of heterologous & homologous prime-boost immunization of COVID-19 vaccines

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.

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.

Full Information

NCT ID

NCT05054621

First Posted

September 13, 2021

Last Updated

October 19, 2021

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05054621

Brief Title

Immunogenicity of COVID-19 Vaccine on Heterologous Schedule

Official Title

A Single-blind, Randomized Study to Evaluate the Immunogenicity of Heterologous Prime-boost COVID-19 Vaccine Schedule

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid-19, Vaccine, Immunogenicity, Reactogenicity, Healthy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Heterologous group

Arm Type

Experimental

Arm Description

1st dose AZD1222, 2nd dose MVC-COV1901

Arm Title

Homologous group (control)

Arm Type

Active Comparator

Arm Description

1st dose AZD1222, 2nd dose AZD1222

Intervention Type

Biological

Intervention Name(s)

Heterologous prime-boost schedule with AZD1222 and MVC-COV1901

Intervention Description

Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.

Intervention Type

Biological

Intervention Name(s)

Homologous prime-boost schedule with two doses of AZD1222

Intervention Description

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 Measure Information:

Title

Immunogenicity: Neutralizing antibody against SARS-CoV-2

Description

Time Frame

Day 28 after booster dose

Secondary Outcome Measure Information:

Title

Immunogenicity：Anti-SARS-CoV-2 Spike antibody

Description

Further determination of Anti-SARS-CoV-2 Spike antibodies in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines

Time Frame

base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine

Title

Adverse events

Description

To evaluate the safety of heterologous & homologous prime-boost immunization of COVID-19 vaccines

Time Frame

through study completion, 6 months.

Title

Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody

Description

Further determination of immunogenicity of Anti-SARS-CoV-2 Nucleocapsid in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.

Time Frame

base line (Day 0) and during the intervention at day 10, 28, 56 and 168 after booster dose of vaccine

Title

Immunogenicity: T cell immunity

Description

Further determination of T cellular immune responses by ELISpot in all participants to heterologous/homologous prime-boost immunization of COVID-19 vaccines.

Time Frame

baseline (Day 0) and during the. intervention at day 10 and 28 after booster dose of vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant is willing and able to give written informed consent for participation in the trial. Male or Female, aged from 20 to 70 years 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. Female participant must: 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; 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. 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: Previous receipt of two or more COVID-19 vaccine doses 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) Pregnancy, lactation or willingness/intention to become pregnant within 3 months post boost vaccine Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrolment. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. Suspected or known current alcohol or drug dependency. 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. Insufficient level of language to undertake all study requirements in opinion of the Investigators. Known HIV antibody positive.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chih-Jung Chen, MD

Phone

+886975365938

james.ped@gmail.com

Facility Information:

Facility Name

ChangGungMH

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact: