Vaccine ReactionPhase 1NCT06002503
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
A Phase 1 study testing Venezuelan Equine Encephalitis DNA Vaccine, PharmaJet Stratis Needle-free Injection System and PharmaJet Tropis Needle-free Injection System in people with Vaccine Reaction, run by PharmaJet, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- Venezuelan Equine Encephalitis DNA Vaccine, PharmaJet Stratis Needle-free Injection System and PharmaJet Tropis Needle-free Injection System
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 31 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Vaccine Reaction
- Being tested
- Venezuelan Equine Encephalitis DNA Vaccine, PharmaJet Stratis Needle-free Injection System, PharmaJet Tropis Needle-free Injection System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venezuelan Equine Encephalitis DNA VaccineDrug
Venezuelan Equine Encephalitis DNA Vaccine Candidate
PharmaJet Stratis Needle-free Injection SystemDevice
Intramuscular Needle-free Injection System (Jet Injector)
PharmaJet Tropis Needle-free Injection SystemDevice
Intradermal Needle-free Injection System (Jet Injector)
| Study group | Role | What they receive |
|---|---|---|
| 1: Intramuscular | Experimental | Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 Receives: Drug: Venezuelan Equine Encephalitis DNA Vaccine; Device: PharmaJet Stratis Needle-free Injection System |
| 2: Intramuscular | Experimental | Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 Receives: Drug: Venezuelan Equine Encephalitis DNA Vaccine; Device: PharmaJet Stratis Needle-free Injection System |
| 3: Intradermal | Experimental | Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 Receives: Drug: Venezuelan Equine Encephalitis DNA Vaccine; Device: PharmaJet Tropis Needle-free Injection System |
| 4: Intradermal | Experimental | Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 Receives: Drug: Venezuelan Equine Encephalitis DNA Vaccine; Device: PharmaJet Tropis Needle-free Injection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with immediate reactions
The nature, frequency, and severity of immediate reactions following vaccination
Measured: 30 minutes after each vaccination
Solicited adverse events
The nature, frequency, and severity of solicited adverse events
Measured: 7 days after each vaccination
Unsolicited adverse events
The nature, frequency, and severity of unsolicited adverse events
Measured: 28 days after the final vaccination
Adverse events
The nature, frequency, and severity of adverse events
Measured: 1 year
Secondary outcomes (2)
VEEV-specific antibody
PsVNA50
Measured: 1 year
Seroconversion rate
PsVNA50
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start16 Oct 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaJet, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002503
- Sponsor's protocol ID
- VEEV-PJ-01
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2023
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06002503
- Acronym / sponsor ID
- VEEV-PJ-01
- Conditions
- Vaccine Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PharmaJet, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Intramuscular | Experimental | Drug: Venezuelan Equine Encephalitis DNA Vaccine, Device: PharmaJet Stratis Needle-free Injection SystemRoute (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 |
| 2: Intramuscular | Experimental | Drug: Venezuelan Equine Encephalitis DNA Vaccine, Device: PharmaJet Stratis Needle-free Injection SystemRoute (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 |
| 3: Intradermal | Experimental | Drug: Venezuelan Equine Encephalitis DNA Vaccine, Device: PharmaJet Tropis Needle-free Injection SystemRoute (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26 |
| 4: Intradermal | Experimental | Drug: Venezuelan Equine Encephalitis DNA Vaccine, Device: PharmaJet Tropis Needle-free Injection SystemRoute (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venezuelan Equine Encephalitis DNA VaccineVenezuelan Equine Encephalitis DNA Vaccine Candidate | Drug | 1: Intramuscular, 2: Intramuscular, 3: Intradermal, 4: Intradermal |
| PharmaJet Stratis Needle-free Injection SystemIntramuscular Needle-free Injection System (Jet Injector) | Device | 1: Intramuscular, 2: Intramuscular |
| PharmaJet Tropis Needle-free Injection SystemIntradermal Needle-free Injection System (Jet Injector) | Device | 3: Intradermal, 4: Intradermal |
Primary outcome
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
2 secondary outcomes
VEEV-specific antibody
Time frame: 1 year
Seroconversion rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venezuelan Equine Encephalitis DNA Vaccine, PharmaJet Stratis Needle-free Injection System and PharmaJet Tropis Needle-free Injection System in people with Vaccine Reaction, run by PharmaJet, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with immediate reactions (time frame: 30 minutes after each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.