Trial Outcomes & Findings for Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™ (NCT NCT02958345)

Last Updated: 2017-07-19

Results Overview

Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

Day 1 and 6 weeks

Results posted on

2017-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Zostavax Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline
Overall Study STARTED	14	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zostavax n=14 Participants Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo n=14 Participants Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline	Total n=28 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	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and 6 weeks

Population: Data was not available for analysis due to laboratory processing error.

Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.

Outcome measures

Outcome measures
Measure	Zostavax Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline
ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay	0	0

SECONDARY outcome

Timeframe: Day 1 and 6 weeks

Population: Data was not available for analysis due to laboratory processing error.

Change in pre and post vaccination Varicella Zoster Virus

Outcome measures

Outcome measures
Measure	Zostavax Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline
GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)	0	0

Adverse Events

Zostavax

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Placebo

Serious events: 4 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Zostavax n=14 participants at risk Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo n=14 participants at risk Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline
General disorders Death	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Stroke	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Cellulitis	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Gastrointestinal disorders Variceal bleed	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Increased ammonia levels and hyponatremia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Decompensated cirrhosis with renal failure	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Decompensated liver failure	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.

Other adverse events

Additional Information

Dr. Luis Balart

Tulane University

Phone: 504-988-3047

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Zostavax n=14 participants at risk Subjects will receive 0.65 mL of Zostavax subcutaneously in the deltoid region of the upper arm. Zostavax: Vaccination with one dose of Zostavax per Zostavax package insert	Placebo n=14 participants at risk Subjects randomized to placebo will receive an injection of 0.65 mL of sterile normal saline subcutaneously in the deltoid region of the upper arm. Placebo: Injection of 0.65 mL of sterile normal saline
General disorders Hyperkalemia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Anemia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Upper respiratory congestion	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Skin and subcutaneous tissue disorders Itching	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Headache	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Skin and subcutaneous tissue disorders Redness at injection site	28.6% 4/14 • Number of events 4 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Skin and subcutaneous tissue disorders Induration	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Pain at injection site	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Sinus infection	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Seasonal allergic rhinitis	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Soreness at injection site	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Vascular disorders Blocked artery in leg	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Epistaxis	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Flu-like symptoms	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Dizziness	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Hepatic encephalopathy	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Urinary tract infection	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Dehydration	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Hyperammonemia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Renal and urinary disorders Acute-on-chronic kidney disease	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Blood and lymphatic system disorders Bacteremia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Nausea	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Vomiting	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Skin and subcutaneous tissue disorders Warmth at injection site	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Swelling	14.3% 2/14 • Number of events 2 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Musculoskeletal and connective tissue disorders Soreness	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Flu	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
General disorders Bleeding from gums	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Injury, poisoning and procedural complications Facial laceration	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Stomach virus	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Bronchitis	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Injury, poisoning and procedural complications Broken rib	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.
Skin and subcutaneous tissue disorders Breast mass	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Klebsiella pneumonia	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.
Infections and infestations Viral upper respiratory infection	0.00% 0/14 • Follow-up Period: Month 1, 2, 3, and 4.	7.1% 1/14 • Number of events 1 • Follow-up Period: Month 1, 2, 3, and 4.