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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is: • Is the VEE DNA Vaccine candidate safe Participants will: * Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection * Provide blood and urine samples * Complete ECGs * Complete physical exams * Complete diaries

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.

What data supports the effectiveness of the DNA vaccine treatment for Venezuelan Equine Encephalomyelitis?

Research shows that the DNA vaccine for Venezuelan Equine Encephalitis, when delivered by needle-free injection, produces strong immune responses in animals like mice and nonhuman primates, protecting them from the virus. This suggests the treatment could be effective in providing immunity against the disease. ^{1 2 3 4 5}

Is the DNA vaccine for Venezuelan Equine Encephalitis safe for humans?

In a Phase 1 clinical trial, the DNA vaccine for Venezuelan Equine Encephalitis was found to be safe and well-tolerated in humans, with no serious side effects reported. ^{1 2 4 6 7}

How does the DNA vaccine for Venezuelan Equine Encephalitis differ from other treatments?

This DNA vaccine is unique because it is delivered using a needle-free jet injection, which is a spring-powered device that can administer the vaccine without a needle, either into the muscle or the skin. This method is less invasive and can be more convenient compared to traditional needle-based injections. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A DNA vaccine for venezuelan equine encephalitis virus delivered by intramuscular electroporation elicits high levels of neutralizing antibodies in multiple animal models and provides protective immunity to mice and nonhuman primates. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A DNA vaccine targeting VEE virus delivered by needle-free jet-injection protects macaques against aerosol challenge. [2022]

3. Egypt pubmed.ncbi.nlm.nih.gov

A Multiagent Alphavirus DNA Vaccine Delivered by Intramuscular Electroporation Elicits Robust and Durable Virus-Specific Immune Responses in Mice and Rabbits and Completely Protects Mice against Lethal Venezuelan, Western, and Eastern Equine Encephalitis Virus Aerosol Challenges. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and protective efficacy of a DNA vaccine against Venezuelan equine encephalitis virus aerosol challenge in nonhuman primates. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The genetic adjuvant IL-12 enhances the protective efficacy of a DNA vaccine for Venezuelan equine encephalitis virus delivered by intramuscular injection in mice. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Phase 1 clinical trial of a DNA vaccine for Venezuelan equine encephalitis delivered by intramuscular or intradermal electroporation. [2017]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of neurovirulence and biodistribution of Venezuelan equine encephalitis replicon particles expressing herpes simplex virus type 2 glycoprotein D. [2007]