IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

NCT05029245 | Withdrawn Phase 3 DMC

• 1 other identifier: STUDY NO. A-03-2021
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19 Vaccine; Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• COVID-19 infection

  8 weeks

• COVID-19 death

  8 weeks

• adverse event after vaccination

  8 weeks

Study Arms (8)

Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal

EXPERIMENTAL

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®

Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular

ACTIVE COMPARATOR

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®

Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal

EXPERIMENTAL

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®

Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular

ACTIVE COMPARATOR

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®

Naive vaccine followed by Comirnaty® 6 microgram Intradermal

EXPERIMENTAL

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®

Naive vaccine followed by Comirnaty® 30 microgram Intramuscular

ACTIVE COMPARATOR

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®

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

EXPERIMENTAL

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®

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

ACTIVE COMPARATOR

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®

Interventions

Comirnaty® BIOLOGICAL

intradermal injection or intramuscular injection

Any history of vaccination with Anti-RBD <650AU/ml followed by Comirnaty® 30 microgram Intramuscular; Any history of vaccination with Anti-RBD< 650AU/ml followed by Comirnaty® 6 microgram Intradermal; Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular; Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal; Naive vaccine followed by Comirnaty® 30 microgram Intramuscular; Naive vaccine followed by Comirnaty® 6 microgram Intradermal; Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular; Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Men and women, ≥18 years of age at time of enrollment.
• Able to follow up the vaccination schedule.

You may not qualify if:

• Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).
• Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).
• Pregnancy with gestational age less than 12 weeks.
• 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).
• Patient with previous used of Intravenous immunoglobulin in previous 6 month
• Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.
• Patient with end stage disease or disease with life expectancy less than 2 years
• Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.
• Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.
• Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead
• Department of Medical services: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Subsai Kongsaengdao, M.D.

Model Details: 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 volunteers. There were flexible 8 arms recruitment up to type of immunological background of 1000 volunteers and availability of BNT162b2 vaccine ( initially estimated 125 volunteers. Per arm)

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 31, 2021
• Study Start: August 31, 2021
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share