Trial Outcomes & Findings for Effects of Persistent Innate Immune Activation on Vaccine Efficacy (NCT NCT02429583)
NCT ID: NCT02429583
Last Updated: 2020-03-04
Results Overview
Titers of anti-hepatitis B surface antigen antibody measured at 8 months Luminex assay for multiplex cytokine/chemokine panel measured at 8 months RNA-Seq with analysis focus on curated ISG list measured at 8 months
TERMINATED
PHASE4
24 participants
8 months
2020-03-04
Participant Flow
Participant milestones
| Measure |
Recombivax in HCV Infected Individuals
Recombivax vaccine administered IM to HCV-infected individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
Recombivax in Healthy Volunteers
Recombivax vaccine administered IM to healthy individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
23
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Persistent Innate Immune Activation on Vaccine Efficacy
Baseline characteristics by cohort
| Measure |
Recombivax in HCV Infected Individuals
n=1 Participants
Recombivax vaccine administered IM to HCV-infected individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
Recombivax in Healthy Volunteers
n=3 Participants
Recombivax vaccine administered IM to healthy individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
44 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: The data was not collected and the analysis was not completed for this study due to insufficient enrollment.
Titers of anti-hepatitis B surface antigen antibody measured at 8 months Luminex assay for multiplex cytokine/chemokine panel measured at 8 months RNA-Seq with analysis focus on curated ISG list measured at 8 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: The data was not collected and the analysis was not completed for this study due to insufficient enrollment.
ELISPOT assays will measured at 8 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: The data was not collected and the analysis was not completed for this study due to insufficient enrollment.
Flow cytometry assays measured at 8 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: The data was not collected and the analysis was not completed for this study due to insufficient enrollment.
Isolated from patient PBMCs measured at 8 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: The data was not collected and the analysis was not completed for this study due to insufficient enrollment.
Isolated from patient PBMCs measured at 8 months
Outcome measures
Outcome data not reported
Adverse Events
Recombivax in HCV Infected Individuals
Recombivax in Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recombivax in HCV Infected Individuals
n=1 participants at risk
Recombivax vaccine administered IM to HCV-infected individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
Recombivax in Healthy Volunteers
n=3 participants at risk
Recombivax vaccine administered IM to healthy individuals
Recombivax: Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
|
|---|---|---|
|
General disorders
Cold Like Symptoms
|
0.00%
0/1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
33.3%
1/3 • Number of events 1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
|
General disorders
Patient Stubbed Toe
|
0.00%
0/1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
33.3%
1/3 • Number of events 1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
|
Surgical and medical procedures
Pain at Injection Site
|
0.00%
0/1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
33.3%
1/3 • Number of events 1 • Up to 30 weeks
Adverse event information was collected from both arms of the study (3 healthy volunteers and 1 HCV infected individual)
|
Additional Information
Aileen O'Connell, Laboratory Manager
The Rockefeller University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place