Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06002503
Other study ID # VEEV-PJ-01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 16, 2023
Est. completion date May 31, 2025

Study information

Verified date March 2024
Source PharmaJet, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Healthy adults, male or female. - Ages at least 18 at the start of the study and no greater than 49 years of age on Day 1 of vaccination. - Participants must be available for all visits and for the complete duration of the study. - Participants must, in the opinion of the Investigator or person obtaining consent, understand the information provided and be capable of providing informed consent. - Women of child bearing 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. - If subject is a sexually active male, must be willing to use an effective method of contraception (such as condoms or be anatomically sterile) from screening until 6 months after the last vaccination. Exclusion Criteria: - Clinically relevant abnormality on history or examination including a history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered to be significant by the designated trial physician 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. - Any of the following laboratory parameters with abnormal values that are moderate in severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, AST, ALT). - If female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination. - Receipt of a blood transfusion or blood products 6 months prior to enrollment. - Participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study. - History of severe local or systemic reactions to vaccination or a history of severe allergic reactions. - History of Guillain-Barre syndrome. - Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C infection (HCV Ab positive); HIV infection, or active syphilis. - History of grand mal epilepsy, or currently taking anti-epileptics. - Any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection. - Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject from participating. - History of syncope or history of a fainting episode within one year of study entry. - Extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles). - Presence of any surgical/traumatic metal implants, or significant scar tissue that may impair appropriate injection at the eligible sites of administration (skin or muscle of the upper left and right deltoid muscles). - In the opinion of the Investigator, is unlikely to comply with the protocol. - As confirmed/reported by the study subject, a history of: exposure to Venezuelan Equine Encephalitis Virus (VEEV) or related alphavirus; prior immunization with an alphavirus replicon-based vaccine; prior immunization with a live-attenuated alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine. - A history of encephalitis as confirmed/reported by the study subject. - Prior immunization against VEEV or related alphavirus or encephalitis, as confirmed/reported by the study subject. - History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse (excluding marijuana) or addiction within 12 months of screening. - Involved in the planning or conduct of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Venezuelan Equine Encephalitis DNA Vaccine
Venezuelan Equine Encephalitis DNA Vaccine Candidate
Device:
PharmaJet Stratis Needle-free Injection System
Intramuscular Needle-free Injection System (Jet Injector)
PharmaJet Tropis Needle-free Injection System
Intradermal Needle-free Injection System (Jet Injector)

Locations

Country Name City State
United States Velocity Clinical Research Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
PharmaJet, Inc. United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with immediate reactions The nature, frequency, and severity of immediate reactions following vaccination 30 minutes after each vaccination
Primary Solicited adverse events The nature, frequency, and severity of solicited adverse events 7 days after each vaccination
Primary Unsolicited adverse events The nature, frequency, and severity of unsolicited adverse events 28 days after the final vaccination
Primary Adverse events The nature, frequency, and severity of adverse events 1 year
Secondary VEEV-specific antibody PsVNA50 1 year
Secondary Seroconversion rate PsVNA50 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06091410 - Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines Phase 4
Completed NCT05057910 - SARS-CoV-2 (Covid-19) RBD Antibody in My Duc Hospital Healthcare Workers
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Recruiting NCT05028257 - Allergy and COVID-19 Vaccines Phase 3
Active, not recruiting NCT06286488 - Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza Phase 4
Recruiting NCT05546502 - Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Phase 3
Completed NCT05869201 - Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine Phase 2/Phase 3
Completed NCT04798677 - Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine N/A
Recruiting NCT05598372 - Infant Pain During Vaccination and Maternal Anxiety N/A
Completed NCT05098600 - The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Completed NCT03400878 - Comparing Morbidity and Mortality Effects of Two Different Strains of BCG Phase 4
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Completed NCT05069714 - One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis. Phase 3
Completed NCT04576910 - Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China Phase 4
Not yet recruiting NCT05094635 - Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts
Recruiting NCT05493917 - A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
Not yet recruiting NCT05171946 - Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults Phase 1
Completed NCT05154383 - Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression Phase 4
Recruiting NCT05128721 - Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19) Phase 1