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

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Optimal Research Alabama, Huntsville, AL
Plague+2 More
rF1V vaccine and CpG 1018® adjuvant - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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

Eligible Conditions

  • Plague
  • Pneumonic Plague
  • Vaccine-Preventable Diseases

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Week 0, 4, 8, 12, 16, 30, 38, 50

Day 28
Select one method of administration of rF1V vaccine with CpG 1018® adjuvant for Part 2
Day 28
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
Day 211
Assess the utility of a 2-dose schedule of rF1V vaccine with CpG 1018® adjuvant
Through week 30
To assess long term clinical benefit from rF1V vaccine with CpG 1018® adjuvant compared with rF1V vaccine
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
Through week 56
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 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.
Week 0
To assess the serum Bridge ELISA concentration to rF1V vaccine with CpG 1018® adjuvant at selected time points after each dose

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Part 1 Group 3: rF1V vaccine and placebo
1 of 4
Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered
1 of 4
Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix
1 of 4
Part 2 Group 1 & 3, OR Group 2 & 3
1 of 4
Active Control
Experimental Treatment

200 Total Participants · 4 Treatment Groups

Primary Treatment: Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered · No Placebo Group · Phase 2

Part 1 Group 1:rF1V vaccine and CpG 1018® adjuvant co-administered
Biological
Experimental Group · 1 Intervention: rF1V vaccine and CpG 1018® adjuvant · Intervention Types: Biological
Part 1 Group 2:rF1V vaccine and CpG 1018® adjuvant bedside mix
Biological
Experimental Group · 1 Intervention: rF1V vaccine and CpG 1018® adjuvant · Intervention Types: Biological
Part 2 Group 1 & 3, OR Group 2 & 3
Biological
Experimental Group · 1 Intervention: rF1V vaccine and CpG 1018® adjuvant · Intervention Types: Biological
Part 1 Group 3: rF1V vaccine and placebo
Biological
ActiveComparator Group · 1 Intervention: rF1V vaccine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 0, 4, 8, 12, 16, 30, 38, 50
Closest Location: Optimal Research Alabama · Huntsville, AL
N/AFirst Recorded Clinical Trial
1 TrialsResearching Plague
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are using hormonal contraception that contains estrogen and/or progestogen.
You are using hormonal contraception that inhibits ovulation.
You are a woman and you have an IUD with or without hormonal release.
You are sexually active and have not had sexual intercourse with a partner in the 28 days prior to vaccination.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.