Trial Outcomes & Findings for A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada (NCT NCT02985450)

NCT ID: NCT02985450

Last Updated: 2021-11-03

Results Overview

to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response

• Recruitment status: COMPLETED
• Target enrollment: 82 participants
• Primary outcome timeframe: 1 month after completion of the vaccine series
• Results posted on: 2021-11-03

Participant Flow

Patients with non-alcoholic fatty liver disease (NAFLD), without prior exposure to hepatitis B or hepatitis B vaccine. Recruitment period was August 2016-March 2020.

No significant events were noted. 7 patients were lost to follow-up.

Participant milestones

Measure	HBV Vaccine Cohort Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care. We followed the product monograph for TWINRIX and Engerix vaccines.
Overall Study STARTED	82
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	HBV Vaccine Cohort Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care. We followed the product monograph for TWINRIX and Engerix vaccines.
Overall Study Lost to Follow-up	7

Baseline Characteristics

A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada

Baseline characteristics by cohort

Measure	HBV Vaccine Cohort n=82 Participants Of 82 participants, all received the HBV vaccine. Vaccines were not blinded as patients were followed as standard of care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	82 participants n=5 Participants
BMI (body mass index)	33.6 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month after completion of the vaccine series

Population: Anti-HBs levels were compared between two groups: low and high-risk obesity patients with NAFLD.

to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response

Outcome measures

Measure	BMI < 35 n=40 Participants 40 patients with BMI \< 35	BMI > 35 n=28 Participants 28 patients with BMI \> 35
Anti-HBs Titres (IU/L)	642 Anti-HBS IU/L Standard Deviation 68.2	385 Anti-HBS IU/L Standard Deviation 79

PRIMARY outcome

Timeframe: 1 month after completion of the vaccine series

Population: 17 patients with BMI \< 35 and 14 patients with BMI \> 35 for PBMC analysis.

to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response. Fresh (or cryopreserved in 4 patients) PBMC (~106) were labeled with 1 μM carboxyfluorescein-diacetate-succinimidyl-ester. Labeled PBMC were stimulated with 5 μg HBsAg) in RPMI 1640 with 10% FBS and 2mmol/L glutamine. Anti-CD3 (1 μg/mL) and anti-CD28 (5 μg/mL) stimulated cells served as a positive control.

Unstimulated DMSO-treated cells were used as negative controls. Cells were cultured in triplicates and plates incubated at 37 °C with 5% CO2 for ~8 days. Cell proliferation was assessed on day 8. SI was calculated as % CFSE low cells in stimulated cells / % CFSE low cells in the unstimulated control46. SI> 3 was considered positive for HBsAg-specific proliferation. Cells were stained using the memory T-cell panel and analyzed by flow-cytometry

Outcome measures

Measure	BMI < 35 n=17 Participants 40 patients with BMI \< 35	BMI > 35 n=14 Participants 28 patients with BMI \> 35
Assessment of Memory T Cells and HBsAg-specific-proliferation of CD3 + CD4+ TH Cells	5.1 Stimulation index Standard Deviation 0.68	3.1 Stimulation index Standard Deviation 0.62

Adverse Events

HBV Vaccine Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.

Carla Coffin

Phone: 403-220-7808

Email: cscoffin@ucalgary.ca

Results disclosure agreements

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