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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, 4, 8, 12, 16, 30, 38, 50
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, 4, 8, 12, 16, 30, 38, 50
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 moreTrial 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rF1V vaccine and CpG 1018® adjuvant
2022
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
869 Previous Clinical Trials
327,516 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old.I have had a heart attack or have been diagnosed with heart disease.I do not have active tuberculosis or any other serious infection.I am not pregnant, breastfeeding, or planning to become pregnant.I haven't received certain vaccines, steroids, or other specific treatments recently.I am currently undergoing or will undergo chemotherapy, and was diagnosed with cancer other than skin cancer in the last 5 years.I have a history of HIV, HBV, or HCV, or tested positive for them.I am healthy or have stable pre-existing conditions.I have used reliable birth control for the last 28 days and will continue for 28 days after my last injection.You have an IUD (a birth control device placed in the uterus) with or without hormones.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 Group 1 & 3, OR Group 2 & 3
- Group 2: Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix
- Group 3: Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered
- Group 4: Part 1 Group 3: rF1V vaccine and placebo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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