Covid19 VaccinePhase 3PRIDENCT05029245
IntraDermal Versus Intramuscular Comirnaty® Efficacy Study
A Phase 3 study testing Comirnaty® in people with Covid19 Vaccine and Covid19, run by Department of Medical Services Ministry of Public Health of Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccine, Covid19
- What is being tested?
- Comirnaty®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2021to 31 Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this 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
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.
Read the 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:
- 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.
Exclusion Criteria:
- 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.
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.
- Conditions
- Covid19 Vaccine, Covid19
- Being tested
- Comirnaty®
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comirnaty®Biological
intradermal injection or intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Comirnaty® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Anti RBD antibody
Level of Anti RBD antibody after first and second injection
Measured: 8 weeks
Interferon gamma level
Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days
Measured: 8 weeks
Secondary outcomes (3)
COVID-19 infection
COVID-19 infection rate after first and second injection
Measured: 8 weeks
COVID-19 death
COVID-19 death rate after first and second injection
Measured: 8 weeks
adverse event after vaccination
adverse event rate after first and second injection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start31 Aug 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: No financial budget support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Department of Medical services
- Responsible party
- Principal investigator, Dr Subsai Kongsaengdao, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029245
- Sponsor's protocol ID
- STUDY NO. A-03-2021
- Acronym
- PRIDE
- Status last verified
- May 2022
- First submitted
- 20 Aug 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05029245
- Acronym / sponsor ID
- PRIDE / STUDY NO. A-03-2021
- Conditions
- Covid19 Vaccine, Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financial budget support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Department of Medical services
- Study start
- 31 Aug 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Exclusion Criteria:
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- 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)
| Arm | Type | Receives |
|---|---|---|
| Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal | Experimental | Biological: Comirnaty®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 |
| Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular | Active comparator | Biological: Comirnaty®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 |
| Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal | Experimental | Biological: Comirnaty®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 |
| Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular | Active comparator | Biological: Comirnaty®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 |
| Naive vaccine followed by Comirnaty® 6 microgram Intradermal | Experimental | Biological: Comirnaty®Patients who had no history SAR-CoV vaccine before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval |
| Naive vaccine followed by Comirnaty® 30 microgram Intramuscular | Active comparator | Biological: Comirnaty®Patients who had no history SAR-CoV vaccine before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval |
| Any history of vaccination with Anti-RBD< 650AU/ml followed by Comirnaty® 6 microgram Intradermal | Experimental | Biological: Comirnaty®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 |
| Any history of vaccination with Anti-RBD <650AU/ml followed by Comirnaty® 30 microgram Intramuscular | Active comparator | Biological: Comirnaty®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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comirnaty®intradermal injection or intramuscular injection | Biological | 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 |
Primary outcome
Level of Anti RBD antibody
Time frame: 8 weeks
Level of Anti RBD antibody after first and second injection
Interferon gamma level
Time frame: 8 weeks
Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days
3 secondary outcomes
COVID-19 infection
Time frame: 8 weeks
COVID-19 death
Time frame: 8 weeks
adverse event after vaccination
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Comirnaty® in people with Covid19 Vaccine and Covid19, run by Department of Medical Services Ministry of Public Health of Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Anti RBD antibody (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.