Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy VolunteersPhase 2NCT06919796
mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes
A Phase 2 study testing COMIRNATY® in people with Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers and SARS CoV-2, run by PharmaJet, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS CoV-2
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 25 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and give informed consent
- Adults aged 18 to 50 years old.
- Willing and able to comply with all scheduled visits, vaccination, and laboratory tests.
- Determined by investigator to be in good health based on medical history, targeted physical exam and laboratory testing.
- Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.
- For women of childbearing potential: willing to engage in effective methods of contraception starting at least 30 days prior to enrollment and for the duration of the study.
Who cannot join
- Receipt of blood products 90 days prior to study entry and for the duration of the study.
- Volunteers who donated blood 60 days before screening OR will donate blood on or before D30.
- Receipt of any experimental agents within 30 days or 5 half-lives whichever is longer prior to vaccination and for the duration of the study.
- Receipt of any licensed vaccine within 60 days prior to study vaccination or planned receipt of any vaccine until 60 days later as well as receipt of COVID-19 vaccine for the duration of the study.
- Receipt of a COVID-19 vaccine or confirmed COVID-19 in the past year or positive SARS-CoV-2 antigen test on vaccination day.
- Chronic medical problems including (but not limited to) autoimmune disease, severe gastrointestinal disease, and grade 4 hypertension.
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- Any diseases or conditions that put individuals at increased risk for severe COVID-19 illness, including: type 1 or 2 diabetes, chronic lung disease (including moderate to severe asthma, bronchiectasis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD), interstitial lung disease including idiopathic pulmonary fibrosis, pulmonary embolism, or pulmonary hypertension), cystic fibrosis, dementia, Parkinson's disease, cerebrovascular disease, chronic liver disease, chronic kidney disease (any stage), heart conditions, hemoglobin blood disorders (sickle cell disease, thalassemia).
- BMI > 40 kg/m2
- Any potentially immune mediated disease (with the exception of well controlled hypothyroidism).
- Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy, radiation therapy (past 12 months) or any other potentially immunosuppressive therapy [i.e. received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Note: Topical medications are allowed.], congenital immunodeficiency, anatomical or functional asplenia.
- Pregnancy or breast feeding or planned pregnancy for the duration of the study.
- Severe reactions to prior vaccination with Covid-19 mRNA vaccine or any of its components, including anaphylaxis.
- History of Guillain Barré syndrome or myopericarditis.
- Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0C], regardless of the route) within 3 days prior to study entry.
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sonia Wimalasena contact
United States1 site
Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of Medicine
Decatur, Georgia, 30030
Nadine Rouphael, MD, 404-712-1435, nroupha@emory.edu
About this study
Official title: Systems Biology of a mRNA Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Given Via Intradermal (ID) Injection Using Tropis Needle-Free Injection System (NFIS) or Intramuscular (IM) Injection Using Needle and Syringe
The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe
- Conditions
- Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS CoV-2
- Being tested
- COMIRNATY®
- Keywords
- Tropis ID, Needle-free injection, Tropis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMIRNATY®Biological
COVID-19 Vaccine, mRNA suspension
| Study group | Role | What they receive |
|---|---|---|
| mRNA vaccine administration via Tropis ID NFIS | Experimental | Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System Receives: Biological: COMIRNATY® |
| Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe | Active comparator | Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe Receives: Biological: COMIRNATY® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
In 40 participants response rate, and magnitude of SARS-CoV-2-specific antibody neutralization titers will be measured at Day 30 and Month 6-9 after vaccination
Measured: Nine months
Secondary outcomes (1)
Secondary Objective
- Percentage of participants with solicited injection site and systemic AEs within 7 days after vaccination.
- Percentage of participants with unsolicited AEs until Day 30 after vaccination.
- Percentage of participants with SAEs, MAAEs and AEs leading to study withdrawal throughout the entire study period.
- Percentage of participants with AESIs (Appendix A) throughout the entire study period.
- Percentage of participants with grade 2 and above AEs within 7 days after each fine needle aspirates of draining lymph nodes and bone marrow aspirates.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy VolunteersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaJet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919796
- Sponsor's protocol ID
- COVID-PJ-01
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Principal Investigator has confirmed IPD will not be shared with other reserchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of a mRNA Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Given Via Intradermal (ID) Injection Using Tropis Needle-Free Injection System (NFIS) or Intramuscular (IM) Injection Using Needle and Syringe
- ClinicalTrials.gov ID
- NCT06919796
- Acronym / sponsor ID
- COVID-PJ-01
- Conditions
- Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS CoV-2
- Keywords
- Tropis ID, Needle-free injection, Tropis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PharmaJet, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 9 Apr 2025 (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 purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA vaccine administration via Tropis ID NFIS | Experimental | Biological: COMIRNATY®Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System |
| Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe | Active comparator | Biological: COMIRNATY®Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand and give informed consent
- Adults aged 18 to 50 years old.
- Willing and able to comply with all scheduled visits, vaccination, and laboratory tests.
- Determined by investigator to be in good health based on medical history, targeted physical exam and laboratory testing.
- Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.
Key exclusion criteria (16 listed)
- Receipt of blood products 90 days prior to study entry and for the duration of the study.
- Volunteers who donated blood 60 days before screening OR will donate blood on or before D30.
- Receipt of any experimental agents within 30 days or 5 half-lives whichever is longer prior to vaccination and for the duration of the study.
- Receipt of any licensed vaccine within 60 days prior to study vaccination or planned receipt of any vaccine until 60 days later as well as receipt of COVID-19 vaccine for the duration of the study.
- Receipt of a COVID-19 vaccine or confirmed COVID-19 in the past year or positive SARS-CoV-2 antigen test on vaccination day.
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®COVID-19 Vaccine, mRNA suspension | Biological | Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe, mRNA vaccine administration via Tropis ID NFIS |
Primary outcome
Primary Objective
Time frame: Nine months
In 40 participants response rate, and magnitude of SARS-CoV-2-specific antibody neutralization titers will be measured at Day 30 and Month 6-9 after vaccination
1 secondary outcome
Secondary Objective
Time frame: Nine months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No. Principal Investigator has confirmed IPD will not be shared with other reserchers
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.
Sonia Wimalasena contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COMIRNATY® in people with Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers and SARS CoV-2, run by PharmaJet, Inc. at 1 site in United States.
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 6 inclusion and 16 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Rouphael, MD (404-712-1435, nroupha@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Nine months). 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 15 Apr 2025.