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Cancer Vaccine

rF1V Vaccine with Adjuvant for Plague

Phase 2
Waitlist Available
Research Sponsored by Dynavax Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, 4, 8, 12, 16, 30, 38, 50
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of two different vaccines for adults ages 18-55.

Who is the study for?
Adults aged 18 to 55, in stable health or with a stable pre-existing condition, can join this trial. They must be able to follow the study plan and give informed consent. Women who could get pregnant must use effective birth control and have negative pregnancy tests before vaccination.Check my eligibility
What is being tested?
This Phase 2 trial is testing how well adults respond to an rF1V vaccine with CpG 1018® adjuvant compared to just the rF1V vaccine alone for preventing diseases like pneumonic plague. Participants are randomly assigned to one of these two groups without knowing which one.See study design
What are the potential side effects?
Possible side effects from the vaccines may include typical reactions at the injection site such as pain, redness, swelling, as well as general symptoms like fever, fatigue, headache, muscle pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, 4, 8, 12, 16, 30, 38, 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 4, 8, 12, 16, 30, 38, 50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine 28 days after the second dose of vaccine
Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant
Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2
Secondary outcome measures
To assess the safety and tolerability of rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine as measured by rates of reactogenicity and adverse events using grading system in CBER's toxicity guidance document.
To assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant at selected time points after each dose
Other outcome measures
To assess long term clinical benefit from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine
To assess the peak serum bridge ELISA concentration from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine 28 days after the complete series
To assess the serum Bridge ELISA concentration to rF1 and rV with CpG1018® adjuvant at selected time points after each dose
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 Group 1 & 3, OR Group 2 & 3Experimental Treatment1 Intervention
Group 1 & 3 (if selected): Group 1: rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183. Group 3: rF1V vaccine and placebo will be administered on Days 1, 29, and 183 OR Group 2 & 3 (if selected): Group 2: Bedside mix of rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29; placebo will be administered on Day 183. Group 3: rF1V vaccine will be administered on Days 1, 29, and 183
Group II: Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mixExperimental Treatment1 Intervention
Bedside mix of rF1V vaccine and CpG 1018® adjuvant and placebo will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183
Group III: Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administeredExperimental Treatment1 Intervention
rF1V vaccine and CpG 1018® adjuvant will be administered on Days 1 and 29, and 2 injections of placebo will be administered on Day 183
Group IV: Part 1 Group 3: rF1V vaccine and placeboActive Control1 Intervention
rF1V vaccine and placebo will be administered on Days 1, 29, and 183

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
226,994 Total Patients Enrolled
Dynavax Technologies CorporationLead Sponsor
28 Previous Clinical Trials
17,180 Total Patients Enrolled
1 Trials studying Vaccine-Preventable Diseases
150 Patients Enrolled for Vaccine-Preventable Diseases
Robert Janssen, MDStudy ChairDynavax Technologies Corporation
4 Previous Clinical Trials
9,070 Total Patients Enrolled
1 Trials studying Vaccine-Preventable Diseases
150 Patients Enrolled for Vaccine-Preventable Diseases

Media Library

rF1V vaccine with CpG 1018® adjuvant (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05506969 — Phase 2
Vaccine-Preventable Diseases Research Study Groups: Part 2 Group 1 & 3, OR Group 2 & 3, Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix, Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered, Part 1 Group 3: rF1V vaccine and placebo
Vaccine-Preventable Diseases Clinical Trial 2023: rF1V vaccine with CpG 1018® adjuvant Highlights & Side Effects. Trial Name: NCT05506969 — Phase 2
rF1V vaccine with CpG 1018® adjuvant (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05506969 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are there in total?

"This clinical trial needs 200 individuals that fit the given inclusion criteria. There are many sites where patients can take part in this research, such as Optimal Research California and Optimal Research Texas."

Answered by AI

Has the FDA cleared rF1V vaccine and CpG 1018® adjuvant for use?

"While there is some clinical evidence suggesting that the rF1V vaccine and CpG 1018® adjuvant are safe, Power rates this as a 2 because there is no data supporting efficacy."

Answered by AI

Could I join the ranks of this research project?

"In order to participate in this trial, patients must be aged 18-55 and have plague. Additionally, the following criteria must be met: adults aged 18-55 years old, in good health or with a pre-existing medical condition that is under control, no major changes in medication within 3 months of Day 1, no recent surgical procedures or hospitalizations/emergency room visits related to the specific medical condition, willing and able to comply with the study schedule and procedures, willing and able to provide written informed consent, using contraception as specified below.This trial is looking for 200 participants who meet the above criteria."

Answered by AI

Is this clinical trial prominent in the United States?

"Optimal Research is administering this clinical trial from 6 different locations: California, Texas, Florida, and 3 additional sites."

Answered by AI

Do people outside of the target age range often try to get into these kind of studies?

"This particular trial is only open to patients aged 18-55, however there are other clinical trials that welcome patients outside of this age range. For example, there are 6 trials for those under 18 years old and 4 trials for patients over 65."

Answered by AI

Is it possible to enroll in this research project at the present time?

"According to the most up-to-date information available on clinicaltrials.gov, this trial is still recruiting patients. The listing for this study was first posted on August 9th, 2022 and edited most recently on August 16th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Optimal Research Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
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
2022. "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. https://clinicaltrials.gov/ct2/show/NCT05506969.
~75 spots leftby Apr 2025
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