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

• ClinicalTrials.gov Identifier: NCT06002503
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: March 25, 2024
• Sponsor: PharmaJet, Inc.
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): PharmaJet, Inc.

Tracking Information

• First Submitted Date: August 8, 2023
• First Posted Date: August 21, 2023
• Last Update Posted Date: March 25, 2024
• Actual Study Start Date: October 16, 2023
• Estimated Primary Completion Date: January 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

• Number of participants with immediate reactions [ Time Frame: 30 minutes after each vaccination ]
  The nature, frequency, and severity of immediate reactions following vaccination
• Solicited adverse events [ Time Frame: 7 days after each vaccination ]
  The nature, frequency, and severity of solicited adverse events
• Unsolicited adverse events [ Time Frame: 28 days after the final vaccination ]
  The nature, frequency, and severity of unsolicited adverse events
• Adverse events [ Time Frame: 1 year ]
  The nature, frequency, and severity of adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 15, 2023)

• VEEV-specific antibody [ Time Frame: 1 year ]
  PsVNA50
• Seroconversion rate [ Time Frame: 1 year ]
  PsVNA50

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
• Official Title: A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults

Brief 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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Vaccine Reaction

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)
• Device: PharmaJet Tropis Needle-free Injection System
  Intradermal Needle-free Injection System (Jet Injector)

Study Arms

• Experimental: 1: Intramuscular
  Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
  Interventions:

  • Drug: Venezuelan Equine Encephalitis DNA Vaccine
  • Device: PharmaJet Stratis Needle-free Injection System
• Experimental: 2: Intramuscular
  Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
  Interventions:

  • Drug: Venezuelan Equine Encephalitis DNA Vaccine
  • Device: PharmaJet Stratis Needle-free Injection System
• Experimental: 3: Intradermal
  Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
  Interventions:

  • Drug: Venezuelan Equine Encephalitis DNA Vaccine
  • Device: PharmaJet Tropis Needle-free Injection System
• Experimental: 4: Intradermal
  Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
  Interventions:

  • Drug: Venezuelan Equine Encephalitis DNA Vaccine
  • Device: PharmaJet Tropis Needle-free Injection System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 15, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2025
• Estimated Primary Completion Date: January 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Mara Kinney, MS; 720-214-9390; mara.kinney@pharmajet.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06002503
• Other Study ID Numbers: VEEV-PJ-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: PharmaJet, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: PharmaJet, Inc.
• Original Study Sponsor: Same as current
• Collaborators: United States Department of Defense
• Investigators: Not Provided
• PRS Account: PharmaJet, Inc.
• Verification Date: March 2024