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

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-50

SponsorPharmaJet, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

COMIRNATY®
Biological/Vaccine
COVID-19 Vaccine, mRNA suspension

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: mRNA vaccine administration via Tropis ID NFISExperimental treatment 1 intervention

Group B: Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringeActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Nine months

Secondary outcomes

Secondary Objective

1. Percentage of participants with solicited injection site and systemic AEs within 7 days after vaccination. 2. Percentage of participants with unsolicited AEs until Day 30 after vaccination. 3. Percentage of participants with SAEs, MAAEs and AEs leading to study withdrawal throughout the entire study period. 4. Percentage of participants with AESIs (Appendix A) throughout the entire study period. 5. 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.

Time frame

Nine months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PharmaJet, Inc.

Lead sponsor

Emory University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: