Clinical trial NCT05029245: IntraDermal Versus Intramuscular Comirnaty® Efficacy Study
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid19 Vaccine
Covid19
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Department of Medical services
First posted: 2021-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 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)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Level of Anti RBD antibody
timeFrame: 8 weeks
measure: Interferon gamma level
timeFrame: 8 weeks
Secondary outcomes:
measure: COVID-19 infection
timeFrame: 8 weeks
measure: COVID-19 death
timeFrame: 8 weeks
measure: adverse event after vaccination
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: