rF1V-1018 Vaccine for Bubonic Plague

Recruiting at 2 trial locations

Overseen By Ouzama Henry, MD, Vice President, Clinical Development

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Dynavax Technologies Corporation

Must not be taking: Immunosuppressants, Immunoglobulins, Antisense oligonucleotides, others

Disqualifiers: Plague, Tuberculosis, HIV, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, rF1V-1018, to evaluate its effectiveness and safety. The goal is to determine if the vaccine can protect against the bubonic plague, a serious infectious disease. Healthy individuals or those with stable medical conditions, aged 18 to 55, might be suitable candidates. Participants should not have previously contracted the plague or received a plague vaccine. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you should not have had major medication changes in the last 3 months. If you are on certain immune-modifying drugs, you may need to stop them 90 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have tested the rF1V-1018 vaccine for safety and tolerability. Research shows that most people tolerate this vaccine well, with few reports of serious side effects. Dynavax, the company behind the vaccine, uses a helper ingredient called CpG 1018 to boost the immune response. This ingredient is also used in other vaccines, suggesting its safety.

Since this trial is in Phase 2, the vaccine has already passed initial safety tests in earlier studies. This phase focuses on further assessing the vaccine's safety and effectiveness. Minor side effects like soreness at the injection site or mild flu-like symptoms may occur, but serious side effects are not expected based on current data. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The rF1V-1018 vaccine is unique because it targets the bubonic plague using a recombinant protein approach, which is different from traditional antibiotics like streptomycin or doxycycline. Researchers are excited because this vaccine aims to stimulate the immune system to prevent infection, rather than just treating it after exposure. This proactive method could offer longer-lasting protection and reduce the reliance on antibiotics, which is crucial in the face of rising antibiotic resistance.

What evidence suggests that this trial's treatments could be effective for bubonic plague?

Research shows that the rF1V-1018 vaccine could help prevent both bubonic and pneumonic plague. This trial will test the vaccine across various treatment arms, each potentially involving different immune-boosting substances. Studies have found that these combinations strengthen the body's defenses. Early results suggest the vaccine creates a strong immune response, which may protect against plague bacteria. Designed to counteract the harmful effects of the plague, current research aims to enhance its effectiveness. Overall, initial evidence supports its potential as an important tool in preventing the plague. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 55 who are in good health and have not previously received a vaccine against Bubonic Plague. Specific eligibility criteria were not provided, but typically participants should not have any chronic diseases or conditions that could interfere with the study.

Inclusion Criteria

Able to comply with the protocol schedule and procedures

Able and willing to provide written informed consent

I am between 18 and 55 years old.

Exclusion Criteria

Body mass index ≥ 30 kg/m2

History of plague disease or have previously received any plague vaccine

History of autoimmune disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses and regimens of rF1V-1018 vaccine

6 months

Periodic visits for study-specific evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• rF1V-1018

Trial Overview The trial is testing rF1V-1018, a new vaccine candidate for preventing Bubonic Plague. The study will assess how well the body responds to the vaccine (immunogenicity), its safety profile, and how well it's tolerated by those receiving it.

How Is the Trial Designed?

Group I: Arm 6 Experimental Treatment 1 Intervention

Group II: Arm 5 Experimental Treatment 1 Intervention

Group III: Arm 4 Experimental Treatment 1 Intervention

Group IV: Arm 3 Experimental Treatment 1 Intervention

Group V: Arm 2 Experimental Treatment 1 Intervention

Group VI: Arm 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dynavax Technologies Corporation

Lead Sponsor

Trials

30

Recruited

17,800+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. cdn.who.int cdn.who.int/media/docs/default-source/documents/r-d-blueprint-meetings/global-consultation-on-plague-vaccines/2_wai-chung_20231012-who-meeting-rf1v-vaccine-dod_dvax-final.pdf?sfvrsn=c07e8548_3

EFFORTS ON THE PLAGUE rF1V VACCINE SINCE 2018 • Study continues with CpG 1018 mixed at time of use. rF1V-1018 Plague Vaccine: Phase 2 Clinical Study. Plague JVAPDVAX 12OCT 2023. 5 |. Part 1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07207408

Immunogenicity, Safety, and Tolerability of rF1V-1018 ... Documented and current bilateral tubal ligation or occlusion. Exclusion Criteria: A history of plague disease or have previously received any ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11007139/

Co-formulation of the rF1V plague vaccine with depot- ... This study evaluated a depot-formulated cytokine-based adjuvant to improve the efficacy of the recombinant F1V (rF1V) plague vaccine and examined the ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/markets-news/Tipranks/35743907/dynavax-technologies-advances-in-pneumonic-plague-vaccine-study/

Dynavax Technologies Advances in Pneumonic Plague ... The intervention being tested is a biological vaccine named rF1V-1018. This vaccine is designed to prevent pneumonic plague, a serious ...

5. nature.com nature.com/articles/s41541-024-00958-1

Progress on the research and development of plague ... Co-formulation of the rF1V plague vaccine with depot-formulated cytokines enhances immunogenicity and efficacy to elicit protective ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25007893

Development of a live-attenuated vaccine challenge model ... Although these data remain unpublished, they suggest that adenoviral-vectored vaccines could represent a viable platform for plague immunization ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11379892/

Progress on the research and development of plague ... Whilst vaccines lacking the V antigen may protect against bubonic plague, several groups showed that the inclusion of the V antigen was an essential requirement ...

8. investors.dynavax.com investors.dynavax.com/news-releases/news-release-details/dynavax-reports-first-quarter-2025-financial-results-and

Dynavax Reports First Quarter 2025 Financial Results and ... Plague Vaccine Program: Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 in collaboration with, and fully funded ...