Adults 18 to 60, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).Primary· Day 1, Day 3, Week 1, and Week 2
Number of differentially expressed genes at time point versus prevaccination baseline (p\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Downregulated
Group
Value
95% CI
Day 1
138
Day 3
138
Week 1
102
Week 2
81
Unchanged
Group
Value
95% CI
Day 1
11139
Day 3
11318
Week 1
11189
Week 2
11361
Upregulated
Group
Value
95% CI
Day 1
316
Day 3
137
Week 1
302
Week 2
151
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).Primary· Day 1, Day 3, Week 1, and Week 2
Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR\<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
Downregulated
Group
Value
95% CI
Day 1
0
Day 3
0
Week 1
0
Week 2
0
Unchanged
Group
Value
95% CI
Day 1
0
Day 3
0
Week 1
0
Week 2
0
Upregulated
Group
Value
95% CI
Day 1
0
Day 3
0
Week 1
0
Week 2
0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan. Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals. The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05272735 — HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers
· Phase 4
· terminated
NCT00414050 — A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
· Phase 3
· completed
Other recruiting trials for Hepatitis B
Currently open trials in the same condition.
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
· Phase 1
· recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
· Phase 1
· recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
· NA
· recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit
· Phase 2
· active not recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rockefeller University
Last refreshed: 7 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02055365.