CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
rF1V-1018 +1 morebiological
Likely dose
rF1V vaccine with or without CpG 1018® adjuvant (specific dose not specified)AI-extracted
Key inclusion· 4
  • ✓Adults aged 18 to 55 years
  • ✓Healthy participants or those with stable pre-existing medical conditions (full daily activity, no major medication changes in 3 months, no recent surgery/hospitalization for that condition)
  • ✓Able to comply with protocol schedule and procedures
  • ✓Able and willing to provide written informed consent
Key exclusion· 10
  • ✕History of plague disease or prior plague vaccine
  • ✕Active tuberculosis or other systemic infectious process
  • ✕History of HIV, hepatitis B, or hepatitis C infection, or positive test for antibody to HIV, HBV, or HCV
  • ✕History of autoimmune disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05506969
NCT05506969Phase 2Completed
CompareCT.gov

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

Dynavax Technologies Corporation·interventional·Posted Aug 18, 2022·Updated Jul 29, 2025

In Brief

A Phase 2 clinical trial evaluating rF1V-1018 and rF1V vaccine for Plague, Pneumonic and 2 related conditions. Completed, enrolled 200 participants across 6 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlague, Pneumonic, Plague, Vaccine-Preventable Diseases
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 18, 2022
Enrollment StartAug 9, 2022
Primary CompletionOct 3, 2023
Study CompletionApr 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.9 years ago

Interventions

rF1V-1018biological

rF1V vaccine and CpG 1018® adjuvant

rF1V vaccinebiological

rF1V vaccine