Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia PestisPhase 2NCT07207408
Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
A Phase 2 study testing rF1V-1018 in people with Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis, run by Dynavax Technologies Corporation at 4 sites in United States.
Trial summary
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis
- What is being tested?
- rF1V-1018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Sep 2025to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18 to 55 years of age
- Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.
- Able to comply with the protocol schedule and procedures
- Able and willing to provide written informed consent
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection
- A premenopausal woman who has at least one of the following is considered not of childbearing potential:
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- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Documented and current bilateral tubal ligation or occlusion
Who cannot join
- A history of plague disease or have previously received any plague vaccine
- Active tuberculosis or other systemic infectious process
- History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV
- History of autoimmune disorder
- History of sensitivity to any component of trial vaccines
- Body mass index ≥ 30 kg/m2
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- Has received the following prior to any trial injection:
- ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigational medicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first trial vaccine administration or planned administration during the trial period. (For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticular steroids are allowed.
- Granulocyte or granulocyte-macrophage colony stimulating factor iii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iv) Antisense oligonucleotides v) Drugs/investigational agents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine, amiodarone, liraglutide, nirsevimab, teplizumab, evinacumab, and obinutuzumab) vi) Infusion of blood products d) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells
- If female is pregnant (known before or established at the time of screening), breastfeeding, or planning breastfeeding or a pregnancy
- Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Oral temperature ≥ 38°C (≥ 100.4°F) at the time of vaccine administration
- History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CTI Clinical Research Center
Cincinnati, Ohio, 45212
AMR- El Dorado
El Dorado, Kansas, 67042
AMR- Las Vegas
Las Vegas, Nevada, 889119
103
Miami, Florida, 33172
About this study
Official title: Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
Read the detailed description
This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial.
Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.
- Being tested
- rF1V-1018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rF1V-1018Biological
Regimen 1
rF1V-1018Biological
Regimen 2
rF1V-1018Biological
Regimen 3
rF1V-1018Biological
Regimen 4
rF1V-1018Biological
Regimen 5
rF1V-1018Biological
Regimen 6
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Arm 1 | Experimental | Not described Receives: Biological: rF1V-1018 |
| Part 1 Arm 2 | Experimental | Not described Receives: Biological: rF1V-1018 |
| Part 1 and Part 2: Arm 3 | Experimental | This Part 1 arm was selected for Part 2. Receives: Biological: rF1V-1018 |
| Part 1 and Part 2: Arm 4 | Experimental | This Part 1 arm was selected for Part 2. Receives: Biological: rF1V-1018 |
| Part 1 Arm 5 | Experimental | Not described Receives: Biological: rF1V-1018 |
| Part 1 Arm 6 | Experimental | Not described Receives: Biological: rF1V-1018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-rF1V antibody level
Measured: 4 weeks after final study vaccine
Evaluate safety of rF1V-1018
Evaluate adverse events
Measured: injection reactions through 7 days after each study vaccine, adverse events for 28 days after each study vaccine; SAEs, MAEs, imAESIs through 6 months after the final study vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start11 Sep 2025
- Primary completion29 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia PestisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207408
- Sponsor's protocol ID
- DV2-DC02-02
- Other IDs
- VCG26632
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
- ClinicalTrials.gov ID
- NCT07207408
- Acronym / sponsor ID
- DV2-DC02-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
Detailed description
This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial.
Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Arm 1 | Experimental | Biological: rF1V-1018 |
| Part 1 Arm 2 | Experimental | Biological: rF1V-1018 |
| Part 1 and Part 2: Arm 3 | Experimental | Biological: rF1V-1018This Part 1 arm was selected for Part 2. |
| Part 1 and Part 2: Arm 4 | Experimental | Biological: rF1V-1018This Part 1 arm was selected for Part 2. |
| Part 1 Arm 5 | Experimental | Biological: rF1V-1018 |
| Part 1 Arm 6 | Experimental | Biological: rF1V-1018 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults 18 to 55 years of age
- Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition.
- Able to comply with the protocol schedule and procedures
- Able and willing to provide written informed consent
- If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection
Key exclusion criteria (15 listed)
- A history of plague disease or have previously received any plague vaccine
- Active tuberculosis or other systemic infectious process
- History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV
- History of autoimmune disorder
- History of sensitivity to any component of trial vaccines
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 |
|---|---|---|
| rF1V-1018Regimen 1 | Biological | Part 1 Arm 1 |
| rF1V-1018Regimen 2 | Biological | Part 1 Arm 2 |
| rF1V-1018Regimen 3 | Biological | Part 1 and Part 2: Arm 3 |
| rF1V-1018Regimen 4 | Biological | Part 1 and Part 2: Arm 4 |
| rF1V-1018Regimen 5 | Biological | Part 1 Arm 5 |
| rF1V-1018Regimen 6 | Biological | Part 1 Arm 6 |
Primary outcome
Anti-rF1V antibody level
Time frame: 4 weeks after final study vaccine
Evaluate safety of rF1V-1018
Time frame: injection reactions through 7 days after each study vaccine, adverse events for 28 days after each study vaccine; SAEs, MAEs, imAESIs through 6 months after the final study vaccine
Evaluate adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rF1V-1018 in people with Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis, run by Dynavax Technologies Corporation at 4 sites 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 10 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Anti-rF1V antibody level (time frame: 4 weeks after final study vaccine). The study lists 2 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 5 Oct 2026.