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Cancer Vaccine

DNA Vaccine via Needle-free Injection for Venezuelan Equine Encephalomyelitis

Phase 1

Recruiting

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Number of participants with immediate reactions

Solicited adverse events

+1 more

Secondary outcome measures

Seroconversion rate

VEEV-specific antibody

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

Do I qualify?Apply below to find out

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

865 Previous Clinical Trials

327,659 Total Patients Enrolled

PharmaJet, Inc.Lead Sponsor

5 Previous Clinical Trials

2,859 Total Patients Enrolled

1 Trials studying Vaccine Reaction

480 Patients Enrolled for Vaccine Reaction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the subject pool of this research limited to adults only?

"To be eligible for this trial, participants must range from 18 to 49 years of age. For those younger or older than that window, there are additional studies with 18 trials dedicated to minors and 30 catered towards elderly patients."

Answered by AI

Is there a high risk associated with intramuscular injections?

"The safety of intramuscular administration is believed to be low, as it has only been tested on a limited scale. We rate its risk level at 1."

Answered by AI

Does my profile meet the criteria to join this research effort?

"To qualify for this research, individuals ought to have been affected by a vaccine and be aged between 18-49. In total, 40 patients are being admitted into the trial."

Answered by AI

Are there any open opportunities for participants in this investigation?

"Clinicaltrials.gov reports that this specific medical trial, which was posted on September 29th 2023 and last updated August 15th 2023, is not currently welcoming candidates. However, 45 other trials are actively enrolling participants as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection

2023. "Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06002503.