Needle-Free vs Needle Injection for COVID-19 Vaccination

Overseen By Nadine Rouphael, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: PharmaJet, Inc.

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Diabetes, Chronic lung disease, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the immune response to the mRNA COVID-19 vaccine, COMIRNATY®, changes when delivered using a needle-free system compared to the traditional needle and syringe. The researchers aim to determine if the needle-free method is equally effective. Healthy individuals with no recent COVID-19 vaccination or infection in the past year might be suitable candidates. This study offers promise for those interested in alternative vaccination methods. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to innovative vaccination methods.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on any immunosuppressive therapy or immune-modifying drugs, you may need to discuss this with the trial investigator.

What prior data suggests that this needle-free injection system is safe for COVID-19 vaccination?

Research shows that the COMIRNATY mRNA COVID-19 vaccine is generally well-tolerated. Common side effects include pain or swelling at the injection site, fatigue, headaches, muscle pain, chills, and fever. These side effects are typical for many vaccines and are usually mild.

However, some serious risks exist, such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart). These are rare but important to consider.

The Tropis Needle Free Injection System is currently under testing, but specific safety data for this method is not yet available. The trial is in an early phase, and researchers are still gathering safety evidence. If the needle-free method passes this phase, it suggests reasonable safety for more extensive testing. Always consult healthcare providers for personal medical advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the needle-free COVID-19 vaccination method because it offers a new way to deliver the vaccine without using the traditional needle and syringe. This innovative approach utilizes the Tropis Needle Free Injection System to administer the vaccine intradermally, potentially making vaccinations less painful and more accessible for those with needle aversions. Additionally, this method could improve distribution efficiency by simplifying the vaccination process, especially in settings with limited medical resources.

What evidence suggests that this trial's treatments could be effective for COVID-19 vaccination?

In this trial, participants will receive the mRNA COVID-19 vaccine, COMIRNATY®, through one of two methods. One group will receive the vaccine via a traditional needle and syringe, which studies have shown to be very effective in preventing COVID-19. Another group will receive the vaccine using the Tropis Needle-Free Injection System. Research suggests that this needle-free method might significantly enhance the immune response and could benefit individuals who fear needles. Both methods aim to provide strong protection against COVID-19. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible to receive the mRNA COVID-19 vaccine. Specific inclusion and exclusion criteria details were not provided, so general eligibility would be based on standard vaccination guidelines.

Inclusion Criteria

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

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

Exclusion Criteria

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

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

BMI > 40 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of mRNA Covid-19 vaccine via either intramuscular injection using needle and syringe or intradermal injection using the Tropis Needle Free Injection System

1 day

Follow-up

Participants are monitored for immune response and adverse events, with primary measurements at Day 30 and Month 6-9 after vaccination

9 months

What Are the Treatments Tested in This Trial?

Interventions

• COMIRNATY®

Trial Overview The study is testing whether the immune response to the mRNA COVID-19 vaccine COMIRNATY® differs when administered through a needle-free injection system versus a traditional needle and syringe method.

How Is the Trial Designed?

Group I: mRNA vaccine administration via Tropis ID NFIS Experimental Treatment 1 Intervention

Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System

Group II: Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe Active Control 1 Intervention

Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe

Who Is Running the Clinical Trial?

PharmaJet, Inc.

Lead Sponsor

Trials

6

Recruited

2,400+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a study of 2030 healthcare workers, those previously infected with COVID-19 reported a higher incidence of side effects after the first dose of the Comirnaty vaccine compared to those who had not been infected, with 46.76% experiencing side effects versus 29.15%.

After the second dose, the side effect rate for previously infected individuals was lower (63.23%) compared to those not previously infected (70.79%), suggesting that prior infection may influence the vaccine's side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Ossato, A., Tessari, R., Trabucchi, C., et al.[2023]

In a survey of 2,659 healthcare workers in Italy, common adverse events following the Comirnaty® COVID-19 vaccine included injection site pain, fatigue, and headache, with severe reactions being more frequent after the second dose and in women.

Despite the frequent occurrence of adverse events, severe reactions were uncommon, supporting the safety of the vaccine and aiding in risk profiling for future vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital. Vigezzi, GP., Lume, A., Minerva, M., et al.[2022]

A total of 4119 adverse event notifications were collected from healthcare professionals administering the Comirnaty® COVID-19 vaccine, with 70% of reported symptoms classified as mild, indicating a generally favorable safety profile.

No hospitalizations or deaths were reported, and the study highlighted a higher frequency of certain adverse events, such as adenomegaly and gastrointestinal disorders, compared to clinical trials, emphasizing the importance of real-world pharmacovigilance for understanding vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous Adverse Event Reporting by COVID-19 Vaccinated Healthcare Professionals Through an Electronic Form Implemented by the Hospital Pharmacy. da Cruz, JPGL., de Carvalho, CDCR., da Cruz Silva, PA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06919796

mRNA Covid-19 Vaccine Immune Response Comparisons ... ... mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System. Intervention/Treatment, Biological : COMIRNATY®. COVID-19 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037851732501124X

An overview of needle-free injection technology in human ... This paper provides a review of needle-free injection technology, covering its classification and development history, research progress in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9767897/

A highly efficient needle-free-injection delivery system for ... In this study, we develop a novel integrated system of LNP-based COVID-19 mRNA vaccines with NFI devices, and study the stability of mRNA-LNP particles under ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/pharmajets-needle-free-delivery-system-proves-effective-in-published-study/

PharmaJet's needle-free delivery system proves effective in ... A study, published in the Nature Journal, demonstrates that PharmaJet's needle-free delivery system Tropis significantly boosts immune responses ...

5. fda.gov fda.gov/media/151707/download

Package Insert and Patient Package Insert – COMIRNATY Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with. COVID-19 vaccine-associated myocarditis is available from ...

6. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=15501

Pfizer-BioNTech/Comirnaty COVID-19 mRNA Vaccine The safety of a booster dose of Comirnaty in participants 12 years of age and older is inferred from safety data from studies of a booster dose of Comirnaty in ...

7. comirnaty.com comirnaty.com/side-effects-safety

Side Effects & Safety | COMIRNATY® (COVID-19 Vaccine, ... Serious risks of COMIRNATY can include: Severe allergic reactions; Myocarditis (inflammation of the heart muscle); Pericarditis (inflammation of the lining ...

8. tga.gov.au tga.gov.au/sites/default/files/cmi-comirnaty-bnt162b2-mrna.pdf

Comirnaty COVID-19 Vaccine Are there any side effects? Very common side effects of COMIRNATY include pain/swelling at injection site, tiredness, headache, muscle pain, chills, fever.