Clinical trial NCT05506969: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plague, Pneumonic
Plague
Vaccine-Preventable Diseases
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2022-08-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2
timeFrame: 28 days after second dose of vaccine of last participant in part 1
measure: Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant
timeFrame: Through day 211 in part 2
measure: 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
timeFrame: 28 days after second dose of vaccine of last participant in part 2
Secondary outcomes:
measure: 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.
timeFrame: Through week 50
measure: To assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant at selected time points after each dose
timeFrame: Week 0, 4, 8, 12, 16, 30, 38, 50
Other outcomes:
measure: To assess long term clinical benefit from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine
timeFrame: Through week 30
measure: 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
timeFrame: Through week 30
measure: 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
timeFrame: Through week 50
measure: To assess the serum Bridge ELISA concentration to rF1 and rV with CpG1018® adjuvant at selected time points after each dose
timeFrame: Through Week 50
Locations:
city: Huntsville
country: United States
facility: Optimal Research Alabama
state: Alabama
city: San Diego
country: United States
facility: Optimal Research California
state: California
city: Melbourne
country: United States
facility: Optimal Research Florida
state: Florida
city: Peoria
country: United States
facility: Optimal Research Illinois
state: Illinois
city: Rockville
country: United States
facility: Optimal Research Maryland
state: Maryland
city: Austin
country: United States
facility: Optimal Research Texas
state: Texas
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_CHAIR
References: