IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

Covid19 Clinical Trial

— PRIDE  

Official title:

The 8-week, Prospective, Randomized Controlled of IntraDermal Administration of Comirnaty® 6 Microgram Versus Intramuscular Comirnaty® 30 Microgram by 28 Days Interval Efficacy Study in Healthy Volunteer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05029245
• Other study ID #: STUDY NO. A-03-2021
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 31, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: May 2022
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Covid19 Vaccine

Intervention

Biological:
• Comirnaty®
intradermal injection or intramuscular injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Department of Medical services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Anti RBD antibody	Level of Anti RBD antibody after first and second injection	8 weeks
Primary	Interferon gamma level	Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days	8 weeks
Secondary	COVID-19 infection	COVID-19 infection rate after first and second injection	8 weeks
Secondary	COVID-19 death	COVID-19 death rate after first and second injection	8 weeks
Secondary	adverse event after vaccination	adverse event rate after first and second injection	8 weeks