DNA Vaccine via Needle-free Injection for Venezuelan Equine Encephalomyelitis

Overseen By Mara Kinney, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: PharmaJet, Inc.

Must not be taking: Corticosteroids, Immunosuppressive, Anticancer, Anti-epileptics

Disqualifiers: Immunodeficiency, Diabetes, Coronary artery disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new DNA vaccine for Venezuelan Equine Encephalitis, a virus that can cause flu-like symptoms and, in severe cases, brain inflammation. The main goal is to determine the vaccine's safety when administered through various needle-free injections. Participants will receive the vaccine, provide blood and urine samples, and undergo several health checks. The study seeks healthy adults who can attend all study visits and have no significant health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using systemic corticosteroids, immunosuppressive, anticancer, or other significant medications, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that DNA vaccines, such as the one for Venezuelan Equine Encephalitis (VEE), are generally safe. These vaccines use simple DNA pieces, which cannot revert to harmful forms.

Studies found that the VEE DNA vaccine, administered without needles, was safe in animal tests, including those on monkeys. These tests demonstrated good immune responses and protection without serious side effects.

The current stage of human testing primarily aims to confirm safety. The vaccine has already passed earlier tests in labs and animals, but human studies are still in the early stages. Participants might experience mild reactions, like soreness at the injection site, which is common with many vaccines.

Overall, available research suggests this DNA vaccine will be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments because they use a DNA vaccine delivered via needle-free injection systems, which is quite different from traditional vaccines for Venezuelan Equine Encephalomyelitis that typically rely on live-attenuated or inactivated viral vaccines. The DNA vaccine offers a novel approach by directly delivering genetic material to provoke an immune response, potentially offering a safer and more stable option. Additionally, the needle-free injection systems, like PharmaJet Tropis and Stratis, provide a painless and efficient way to administer the vaccine, which could increase patient compliance and reduce the risk of needle-associated complications. These advancements might lead to quicker, more robust immune responses, making the fight against Venezuelan Equine Encephalomyelitis more effective and accessible.

What evidence suggests that this trial's treatments could be effective for Venezuelan Equine Encephalitis?

Research has shown that the Venezuelan Equine Encephalitis (VEE) DNA vaccine holds promise in generating strong immune responses. In this trial, participants will receive the vaccine either intramuscularly or intradermally through a needle-free injection system. One study found that administering the vaccine into either the muscle or the skin offered significant protection against the virus. This protection arises from both antibodies and immune cells. Additionally, DNA vaccines like this one are generally safe and can be developed quickly. Early results suggest that this vaccine could effectively protect against the VEE virus. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Healthy adults aged 18-49 who can attend all study visits and understand the trial process. Women must not be pregnant, breastfeeding, or planning pregnancy soon; both genders must agree to use contraception. Excluded are those with certain abnormal lab results, recent blood transfusions, other clinical trial participation within 12 weeks, bleeding disorders, history of encephalitis or severe vaccine reactions, significant health conditions like diabetes or heart disease, metal implants at injection sites, exposure to VEEV or related vaccines.

Inclusion Criteria

I understand the study details and can give my consent.

Women of childbearing potential (WOCBP) must have a negative pregnancy test and be willing to use an effective method of contraception: oral contraception, diaphragm, cervical cap, intrauterine device, condom, or be anatomically sterile (in self or partner) from the date of screening until at least 6 months after the last vaccination

I am a healthy adult.

Exclusion Criteria

I don't have extensive tattoos on my upper arms where shots are given.

I haven't used steroids, immunosuppressants, or significant medications in the last 6 months.

Any acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the Investigator, would preclude participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection, provide blood and urine samples, complete ECGs, physical exams, and diaries

26 weeks

3-4 visits (in-person) for vaccinations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and seroconversion rate

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Venezuelan Equine Encephalitis DNA Vaccine

Trial Overview The trial is testing a Venezuelan Equine Encephalitis (VEE) DNA Vaccine's safety when delivered by jet injection into muscle or skin. Participants will receive the vaccine candidate and undergo monitoring through blood/urine tests, ECGs (heart activity tests), physical exams and keeping diaries of their condition.

How Is the Trial Designed?

Group I: 4: Intradermal Experimental Treatment 2 Interventions

Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4

Group II: 3: Intradermal Experimental Treatment 2 Interventions

Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26

Group III: 2: Intramuscular Experimental Treatment 2 Interventions

Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4

Group IV: 1: Intramuscular Experimental Treatment 2 Interventions

Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26

Who Is Running the Clinical Trial?

PharmaJet, Inc.

Lead Sponsor

Trials

6

Recruited

2,400+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pharmajet.com pharmajet.com/first-human-clinical-study-to-assess-u-s-department-of-defense-dna-vaccine-candidate-against-venezuelan-equine-encephalitis-delivered-with-pharmajet-precision-delivery-systems/

First Human Clinical Study to Assess U.S. Department of ... Phase 1 human clinical study will evaluate safety and immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA vaccine.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06002503

Study Details | NCT06002503 | Safety, Reactogenicity and ... Participants will: Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection; Provide blood and urine samples; Complete ECGs ...

3. nature.com nature.com/articles/s41541-022-00469-x

A DNA vaccine targeting VEE virus delivered by needle ... The protective efficacy was assessed following aerosol challenge. We found that a prime and single boost by either the IM or ID route resulted ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9964240/

Improved DNA Vaccine Delivery with Needle-Free Injection ... The advantages of DNA vaccines compared to other types of vaccines include an improved safety profile, ease and speed of development by leveraging the power of ...

5. pharmajet.com pharmajet.com/pharmajet-announces-u-s-government-award-expansion-to-clinically-assess-a-dna-vaccine-combined-with-its-systems/

PharmaJet announces U.S. Government award expansion ... PharmaJet will clinically assess the effective delivery of a Venezuelan Equine Encephalitis Virus DNA candidate vaccine with either Tropis® ...

6. researchgate.net researchgate.net/publication/360110896_A_DNA_vaccine_targeting_VEE_virus_delivered_by_needle-free_jet-injection_protects_macaques_against_aerosol_challenge

(PDF) A DNA vaccine targeting VEE virus delivered by ... A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge ... PharmaJet Tropis injector delivers ...