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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

Primary Purpose

Plague, Pneumonic, Plague, Vaccine-Preventable Diseases

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rF1V vaccine and CpG 1018® adjuvant
rF1V vaccine
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plague, Pneumonic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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
  • Has received the following prior to the injection:
  • 14 days:
  • COVID-19 vaccine
  • 28 days:
  • Any other vaccine
  • Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immunomodulators immune suppressive medication, with the exception of inhaled steroids
  • Granulocyte or granulocyte-macrophage colony-stimulating factor
  • Any other investigational medicinal agent
  • 90 days: immunoglobulins or any blood products
  • At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides
  • 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)

Sites / Locations

  • Optimal Research Alabama
  • Optimal Research California
  • Optimal Research Florida
  • Optimal Research Illinois
  • Optimal Research Maryland
  • Optimal Research Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered

Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix

Part 1 Group 3: rF1V vaccine and placebo

Part 2 Group 1 & 3, OR Group 2 & 3

Arm Description

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

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

rF1V vaccine and placebo will be administered on Days 1, 29, and 183

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

Outcomes

Primary Outcome Measures

Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2
To select one of the two methods of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2 by comparing humoral immunization response 28 days after the second dose of vaccine
Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant
To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant as measured by reduction in time to onset of predicted rF1V protection
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

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

Full Information

First Posted
August 10, 2022
Last Updated
September 29, 2023
Sponsor
Dynavax Technologies Corporation
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05506969
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
Phase 2, randomized, active-controlled, observer-blind, multicenter trial of the immunogenicity, safety, and tolerability of rF1V vaccine with CpG 1018® adjuvant 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 vaccine with CpG 1018® adjuvant administered on study Days 1 and 29 (and placebo at Day 183) with a three-dose regimen of rF1V vaccine alone administered on study Days 1, 29, and 183. The study will be conducted in 2 parts (Part 1 and Part 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plague, Pneumonic, Plague, Vaccine-Preventable Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered
Arm Type
Experimental
Arm Description
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
Arm Title
Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix
Arm Type
Experimental
Arm Description
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
Arm Title
Part 1 Group 3: rF1V vaccine and placebo
Arm Type
Active Comparator
Arm Description
rF1V vaccine and placebo will be administered on Days 1, 29, and 183
Arm Title
Part 2 Group 1 & 3, OR Group 2 & 3
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine and CpG 1018® adjuvant
Intervention Description
rF1V vaccine and CpG 1018® adjuvant
Intervention Type
Biological
Intervention Name(s)
rF1V vaccine
Intervention Description
rF1V vaccine
Primary Outcome Measure Information:
Title
Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2
Description
To select one of the two methods of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2 by comparing humoral immunization response 28 days after the second dose of vaccine
Time Frame
28 days after second dose of vaccine of last participant in part 1
Title
Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant
Description
To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant as measured by reduction in time to onset of predicted rF1V protection
Time Frame
Through day 211 in part 2
Title
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
Time Frame
28 days after second dose of vaccine of last participant in part 2
Secondary Outcome Measure Information:
Title
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.
Time Frame
Through week 50
Title
To assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant at selected time points after each dose
Time Frame
Week 0, 4, 8, 12, 16, 30, 38, 50
Other Pre-specified Outcome Measures:
Title
To assess long term clinical benefit from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine
Time Frame
Through week 30
Title
To assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant as measured by reduction in time to onset of predicted rF1V protection using peak serum Bridge ELISA concentration
Time Frame
Through week 30
Title
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
Time Frame
Through week 50
Title
To assess the serum Bridge ELISA concentration to rF1 and rV with CpG1018® adjuvant at selected time points after each dose
Time Frame
Through Week 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Janssen, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Optimal Research Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802-2569
Country
United States
Facility Name
Optimal Research California
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Optimal Research Florida
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934-8172
Country
United States
Facility Name
Optimal Research Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614-4885
Country
United States
Facility Name
Optimal Research Maryland
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Optimal Research Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-2655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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