Plague, PneumonicPhase 2NCT05506969
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
A Phase 2 study testing rF1V-1018 and rF1V vaccine in people with Plague, Pneumonic and Plague, run by Dynavax Technologies Corporation at 6 sites in United States.
Trial summary
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- What is being tested?
- rF1V-1018 and rF1V vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Aug 2022to 26 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 aged 18 to 55 years
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- Pre-existing stable medical condition means a subject 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 28 days prior to vaccination and has negative pregnancy tests just prior to vaccination and has agreed to continue adequate contraception until 28 days after last study injection. Adequate contraception is defined as a contraceptive method with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:
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- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- Progestin-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
- Intrauterine device (IUD) with or without hormonal release
- Vasectomized partner, provided he is the subject's sole partner and that he has received a medical assessment of the surgical success
- Credible self-reported history of heterosexual abstinence for at least 28 days prior to vaccine administration
- Female partner
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 study vaccines
- Body mass index ≥ 30 kg/m2
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- Has received the following prior to the injection:
- 14 days:
- COVID-19 vaccine
- Any inactivated vaccine
- 28 days:
- Any live vaccine
- Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immunomodulators immune suppressive medication, with the exception of inhaled steroids
- Any other investigational medicinal agent
- 90 days:
- Immunoglobulins or any blood products
- Granulocyte or granulocyte-macrophage colony-stimulating factor
- Antisense oligonucleotides
- Drugs/investigational agents with very long half-lives (defined as ≥ 60 days)
- 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 a pregnancy
- Is undergoing chemotherapy or expected to receive chemotherapy during the study 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 study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Oral temperature >100.0°F at the time of vaccine administration.
- History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Optimal Research Texas
Austin, Texas, 78705-2655
Optimal Research Alabama
Huntsville, Alabama, 35802-2569
Optimal Research Florida
Melbourne, Florida, 32934-8172
Optimal Research Illinois
Peoria, Illinois, 61614-4885
Optimal Research Maryland
Rockville, Maryland, 20850
Optimal Research California
San Diego, California, 92108
About this study
Official title: Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
Read the detailed description
Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant (rF1V-1018) compared with rF1V vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be enrolled to compare a two-dose regimen of rF1V-1018 with a three-dose regimen of rF1V vaccine alone. The study will be conducted in 2 parts (Part 1 and Part 2).
- Conditions
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- Being tested
- rF1V-1018, rF1V vaccine
- Medical subject headings
- Plague, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rF1V-1018Biological
rF1V vaccine and CpG 1018® adjuvant
rF1V vaccineBiological
rF1V vaccine
| Study group | Role | What they receive |
|---|---|---|
| rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered) | Experimental | Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections Receives: Biological: rF1V-1018 |
| rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix) | Experimental | Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections Receives: Biological: rF1V-1018 |
| rF1V vaccine only | Experimental | rF1V vaccine administered as 3 injections Receives: Biological: rF1V vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Reactogenicity and Safety
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
Measured: Day 1 to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start9 Aug 2022
- Primary completion3 Oct 2023
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plague, PneumonicStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Robert Janssen, MD, Study chair, Dynavax Technologies Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506969
- Sponsor's protocol ID
- DV2-PLG-01
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2022
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
- ClinicalTrials.gov ID
- NCT05506969
- Acronym / sponsor ID
- DV2-PLG-01
- Conditions
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
Detailed description
Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant (rF1V-1018) compared with rF1V vaccine alone in adults. Approximately two hundred healthy adults 18 to 55 years of age will be enrolled to compare a two-dose regimen of rF1V-1018 with a three-dose regimen of rF1V vaccine alone. The study will be conducted in 2 parts (Part 1 and Part 2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered) | Experimental | Biological: rF1V-1018Co-administration of rF1V vaccine and CpG 1018® adjuvant administered as 2 injections |
| rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix) | Experimental | Biological: rF1V-1018Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered administered as 2 injections |
| rF1V vaccine only | Experimental | Biological: rF1V vaccinerF1V vaccine administered as 3 injections |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adults aged 18 to 55 years
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- Pre-existing stable medical condition means a subject 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
Key exclusion criteria (25 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 study 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-1018rF1V vaccine and CpG 1018® adjuvant | Biological | rF1V-1018 co-administered (rF1V vaccine and CpG 1018® adjuvant co-administered), rF1V-bedside mix (rF1V vaccine and CpG 1018® adjuvant bedside mix) |
| rF1V vaccinerF1V vaccine | Biological | rF1V vaccine only |
Primary outcome
Rates of Reactogenicity and Safety
Time frame: Day 1 to Week 56
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Plague, Pneumonic
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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.
Robert Janssen, MD study chair
Dynavax Technologies Corporation
6 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 and rF1V vaccine in people with Plague, Pneumonic and Plague, run by Dynavax Technologies Corporation at 6 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rates of Reactogenicity and Safety (time frame: Day 1 to Week 56). 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 29 Jul 2025.