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
Brief Summary

The purpose of this study is to determine if immune responses differ when the mRNACOVID-19 vaccine is given through different delivery methods, including a needle-freeinjection system, or via intramuscular injection using needle and syringe

Detailed Description

Not Provided

Not yet recruiting
Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers
SARS CoV-2

Biological: COMIRNATY®

COVID-19 Vaccine, mRNA suspension

Eligibility Criteria

Inclusion Criteria:

1. Able to understand and give informed consent

2. Adults aged 18 to 50 years old.

3. Willing and able to comply with all scheduled visits, vaccination, and laboratory
tests.

4. Determined by investigator to be in good health based on medical history, targeted
physical exam and laboratory testing.

5. 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.

6. 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.

Exclusion Criteria:

1. Receipt of blood products 90 days prior to study entry and for the duration of the
study.

2. Volunteers who donated blood 60 days before screening OR will donate blood on or
before D30.

3. 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.

4. 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.

5. Receipt of a COVID-19 vaccine or confirmed COVID-19 in the past year or positive
SARS-CoV-2 antigen test on vaccination day.

6. Chronic medical problems including (but not limited to) autoimmune disease, severe
gastrointestinal disease, and grade 4 hypertension.

7. 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).

8. BMI > 40 kg/m2

9. Any potentially immune mediated disease (with the exception of well controlled
hypothyroidism).

10. 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.

11. 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.

12. Pregnancy or breast feeding or planned pregnancy for the duration of the study.

13. Severe reactions to prior vaccination with Covid-19 mRNA vaccine or any of its
components, including anaphylaxis.

14. History of Guillain Barré syndrome or myopericarditis.

15. Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0C],
regardless of the route) within 3 days prior to study entry.

16. Social, occupational, or any other condition that in the opinion of the investigator
might interfere with compliance with the study and vaccine evaluation.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
United States
Locations

Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of Medicine
Decatur, Georgia, United States

Investigator: Nadine Rouphael, MD
Contact: 404-712-1435
nroupha@emory.edu

Contacts

Nadine Rouphael, MD
404-712-1435
nroupha@emory.edu

Sonia Wimalasena
sonia.tandon@emory.edu

Not Provided

Emory University
NCT Number
Keywords
Tropis ID
Needle-free injection
Tropis
MeSH Terms
COVID-19