IntraDermal Versus Intramuscular Comirnaty® Efficacy Study (PRIDE)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19; Covid19 Vaccine
• Intervention / Treatment: Biological: Comirnaty®

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Active Comparator: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Experimental: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Active Comparator: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Experimental: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Active Comparator: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Experimental: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection
Active Comparator: 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	Biological: Comirnaty®; intradermal injection or intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Anti RBD antibody	Level of Anti RBD antibody after first and second injection	8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 infection	COVID-19 infection rate after first and second injection	8 weeks
COVID-19 death	COVID-19 death rate after first and second injection	8 weeks
adverse event after vaccination	adverse event rate after first and second injection	8 weeks

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Collaborators: Department of Medical services

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STUDY NO. A-03-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No