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Cancer Vaccine

DNA Vaccine via Needle-free Injection for Venezuelan Equine Encephalomyelitis

Phase 1
Waitlist Available
Research Sponsored by PharmaJet, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety of a vaccine candidate given by injection and observes its effects. #ClinicalTrial #VaccineSafety

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include local reactions at the injection site such as pain and swelling; systemic reactions may involve feverish symptoms similar to mild flu-like symptoms. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Number of participants with immediate reactions
Solicited adverse events
+1 more
Secondary study objectives
Seroconversion rate
VEEV-specific antibody

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4: IntradermalExperimental Treatment2 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: IntradermalExperimental Treatment2 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: IntramuscularExperimental Treatment2 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: IntramuscularExperimental Treatment2 Interventions
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

United States Department of DefenseFED
908 Previous Clinical Trials
333,634 Total Patients Enrolled
PharmaJet, Inc.Lead Sponsor
5 Previous Clinical Trials
2,379 Total Patients Enrolled
1 Trials studying Vaccine Reaction
~15 spots leftby May 2025
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