mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes

Part of paid clinical trials in Decatur, Georgia.

Sponsor
PharmaJet, Inc.
Study ID
NCT06919796
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Evaluate Immune Responses Following mRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers
  • SARS CoV-2

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • COMIRNATY® — BIOLOGICAL
    COVID-19 Vaccine, mRNA suspension

Study Details

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

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
May 1, 2026
Completion
Nov 25, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mRNA vaccine administration via Tropis ID NFIS
    Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System
  • Active Comparator: Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe
    Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe

Primary Outcome Measure

Primary Objective [ Time Frame: Nine months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of MedicineDecaturGeorgia30030
Nadine Rouphael, MD
[email protected]
404-712-1435

Find similar trials in Decatur, GA

By research site
Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of Medicine· Decatur, GA