Clinical trial NCT06002503: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Vaccine Reaction
Lead sponsor: PharmaJet, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2023-08-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Number of participants with immediate reactions
timeFrame: 30 minutes after each vaccination
measure: Solicited adverse events
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse events
timeFrame: 28 days after the final vaccination
measure: Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: VEEV-specific antibody
timeFrame: 1 year
measure: Seroconversion rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
Study officials:
References: