IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

NCT ID: NCT05029245

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-10-31

Brief Summary

The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in 4 groups of healthy volunteer ( 1 people who complete sinovac vaccination 2 people who received 1 dosage of AstraZeneca vaccine 3 naive vaccination 4 any other vaccination not in 1-3 with anti Spike antibody less than 650 AU/ ml) . Comparison of antibody level and T cell response to SAR-CoV-2 antigen in vitro after 28 day post vaccination is primary outcome and the side effect as well as infection rate in 8 weeks is secondary outcomes.

Detailed Description

The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in healthy volunteer.To compare the AntiSpike antibody, ( Anti RBD ) neutralized antibody ( if possible) of SAR-CoV-2 and T-cell response after injection with Intradermal Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval in healthy volunteer in various immunological background groups.1000 patients with or with out vaccinated and with our without history of previous COVID-19 infection (in various immunological background ) will be recruited and received Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval

Inclusion Criteria:

1. Signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.

2. Men and women, ≥18 years of age at time of enrollment.

3. Able to follow up the vaccination schedule.

Exclusion Criteria:

1. Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).

2. Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).

3. Pregnancy with gestational age less than 12 weeks.

4. Patient with History of immunosuppessive drug ( oral , IV, IM ) of which discontinue less than 6 month or any immunological abnormality which impact to Antibody production and T cell function ( eg hypergammaglobulinemia, active immne deficiency).

5. Patient with previous used of Intravenous immunoglobulin in previous 6 month

6. Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.

7. Patient with end stage disease or disease with life expectancy less than 2 years

8. Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.

9. Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.

10. Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.

Primary efficacy: To compare the AntiSpike antibody, ( Anti RBD ) neutralized antibody ( if possible) of SAR-CoV-2 and T-cell response after injection with Intradermal Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval in healthy volunteer in various immunological background groups.

Secondary efficacy: Comparesion of infection rate in each arm.

Conditions

Covid19 Vaccine; Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal

Patients who had history of ChAdOX1 Cov-19 vaccine 1 dosage at least 1 month before enrollment will received Intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval

Group Type: EXPERIMENTAL

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular

Patients who had history of ChAdOX1 Cov-19 vaccine 1 dosage at least 1 month before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval

Group Type: ACTIVE_COMPARATOR

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Naive vaccine followed by Comirnaty® 6 microgram Intradermal

Patients who had no history SAR-CoV vaccine before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval

Group Type: EXPERIMENTAL

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Naive vaccine followed by Comirnaty® 30 microgram Intramuscular

Patients who had no history SAR-CoV vaccine before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval

Group Type: ACTIVE_COMPARATOR

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Any history of vaccination with Anti-RBD< 650AU/ml followed by Comirnaty® 6 microgram Intradermal

Patients who had history of any SAR-CoV vaccine at least 1 month before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval

Group Type: EXPERIMENTAL

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Any history of vaccination with Anti-RBD <650AU/ml followed by Comirnaty® 30 microgram Intramuscular

Patients who had history of any SAR-CoV vaccine at least 1 month before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval

Group Type: ACTIVE_COMPARATOR

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal

Patients who had history of Coronavac vaccine 2 dosage at least 1 month before enrollment will received Intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval

Group Type: EXPERIMENTAL

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular

Patients who had history of Coronavac vaccine 2 dosage at least 1 month before enrollment will received Intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval

Group Type: ACTIVE_COMPARATOR

Comirnaty®

Intervention Type: BIOLOGICAL

intradermal injection or intramuscular injection

Interventions

Comirnaty®

intradermal injection or intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.

2. Men and women, ≥18 years of age at time of enrollment.

3. Able to follow up the vaccination schedule.

Exclusion Criteria

1. Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).

2. Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).

3. Pregnancy with gestational age less than 12 weeks.

4. Patient with History of immunosuppessive drug ( oral , IV, IM ) of which discontinue less than 6 month or any immunological abnormality which impact to Antibody production and T cell function ( eg hypergammaglobulinemia, active immne deficiency).

5. Patient with previous used of Intravenous immunoglobulin in previous 6 month

6. Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.

7. Patient with end stage disease or disease with life expectancy less than 2 years

8. Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.

9. Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.

10. Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Medical services

UNKNOWN

Sponsor Role: collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Subsai Kongsaengdao

Associate Professor Subsai Kongsaengdao, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STUDY NO. A-03-2021

Identifier Type: -

Identifier Source: org_study_id