IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

Phase 3

Withdrawn

• Conditions: Covid19; Covid19 Vaccine

• Registration Number: NCT05029245
• Lead Sponsor: Rajavithi Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-25
• Study Start: 2021-08-31
• Study First Posted: 2021-08-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-08-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Level of Anti RBD antibody	8 weeks	Level of Anti RBD antibody after first and second injection
Interferon gamma level	8 weeks	Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days

Secondary Outcome Measures

Name	Time	Method
adverse event after vaccination	8 weeks	adverse event rate after first and second injection
COVID-19 infection	8 weeks	COVID-19 infection rate after first and second injection
COVID-19 death	8 weeks	COVID-19 death rate after first and second injection