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Trial Outcomes & Findings for Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers (NCT NCT02055365)

NCT ID: NCT02055365

Last Updated: 2018-05-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 1, Day 3, Week 1, and Week 2

Results posted on

2018-05-07

Participant Flow

Participant milestones

Participant milestones
Measure
Hepatitis B Vaccination
All subjects will receive the standard 3-dose course of Recombivax Hepatitis B (HB) (Merck) - Hepatitis B Vaccine (Recombinant). Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Overall Study
STARTED
10
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Hepatitis B Vaccination
All subjects will receive the standard 3-dose course of Recombivax Hepatitis B (HB) (Merck) - Hepatitis B Vaccine (Recombinant). Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Overall Study
Prematurely Withdrawn
1

Baseline Characteristics

Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Hepatitis B Vaccination
n=9 Participants
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 3, Week 1, and Week 2

Population: All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq (RNA sequencing) data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).

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.

Outcome measures

Outcome measures
Measure
Day 1
n=9 Participants
Differentially expressed genes at Day 1 versus pre-vaccination baseline (p\<0.05).
Day 3
n=9 Participants
Differentially expressed genes at Day 3 versus pre-vaccination baseline (p\<0.05).
Week 1
n=9 Participants
Differentially expressed genes at Week 1 versus pre-vaccination baseline (p\<0.05).
Week 2
n=9 Participants
Differentially expressed genes at Week 2 versus pre-vaccination baseline (p\<0.05).
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Downregulated
138 number of genes at p<0.05
138 number of genes at p<0.05
102 number of genes at p<0.05
81 number of genes at p<0.05
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Unchanged
11139 number of genes at p<0.05
11318 number of genes at p<0.05
11189 number of genes at p<0.05
11361 number of genes at p<0.05
Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Upregulated
316 number of genes at p<0.05
137 number of genes at p<0.05
302 number of genes at p<0.05
151 number of genes at p<0.05

PRIMARY outcome

Timeframe: Day 1, Day 3, Week 1, and Week 2

Population: All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).

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.

Outcome measures

Outcome measures
Measure
Day 1
n=9 Participants
Differentially expressed genes at Day 1 versus pre-vaccination baseline (p\<0.05).
Day 3
n=9 Participants
Differentially expressed genes at Day 3 versus pre-vaccination baseline (p\<0.05).
Week 1
n=9 Participants
Differentially expressed genes at Week 1 versus pre-vaccination baseline (p\<0.05).
Week 2
n=9 Participants
Differentially expressed genes at Week 2 versus pre-vaccination baseline (p\<0.05).
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Downregulated
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Unchanged
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Upregulated
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05
0 number of genes at FDR<0.05

Adverse Events

Hepatitis B Vaccination

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Hepatitis B Vaccination
n=9 participants at risk
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). Hepatitis B Vaccine (Recombinant): All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Respiratory, thoracic and mediastinal disorders
Scratchy Throat
11.1%
1/9
Skin and subcutaneous tissue disorders
mild ecchymosis
11.1%
1/9
Nervous system disorders
light headedness
11.1%
1/9

Additional Information

Brad Rosenberg, MD, PhD

Icahn School of Medicine at Mount Sinai

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place