Trial Outcomes & Findings for ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors (NCT NCT02444936)

Last Updated: 2018-04-06

Results Overview

To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.

Recruitment status

UNKNOWN

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

3 years

Results posted on

2018-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	ZOSTAVAX ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection ZOSTAVAX: Shingles vaccine	Control There is no drug given in this arm.
Overall Study STARTED	10	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZOSTAVAX n=10 Participants ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection ZOSTAVAX: Shingles vaccine	Control n=12 Participants There is no drug given in this arm.	Total n=22 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	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	65.7 years STANDARD_DEVIATION 6.6 • n=5 Participants	64 years STANDARD_DEVIATION 9.8 • n=7 Participants	64.7 years STANDARD_DEVIATION 8.3 • 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	10 Participants n=5 Participants	12 Participants n=7 Participants	22 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.

Outcome measures

Outcome measures
Measure	ZOSTAVAX n=10 Participants ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection ZOSTAVAX: Shingles vaccine	Control n=12 Participants There is no drug given in this arm.
Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures	2 Participants	0 Participants

Adverse Events

ZOSTAVAX

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ZOSTAVAX n=10 participants at risk ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection ZOSTAVAX: Shingles vaccine	Control n=12 participants at risk There is no drug given in this arm.
Musculoskeletal and connective tissue disorders mild injection soreness	20.0% 2/10 • Number of events 2 • We collected the data for the one month after giving the vaccine. We have the subjects complete a vaccine side effect report card.	0.00% 0/12 • We collected the data for the one month after giving the vaccine. We have the subjects complete a vaccine side effect report card.

Additional Information

Dr. David Canaday

Cleveland VA

Phone: 216-368-8901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place