ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 456 for:    Shingles

T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01911065
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : March 3, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Herpes Zoster
Intervention: Biological: Zostavax™

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zostavax™ Vaccine Group Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
Naturally-acquired VZV Immunity Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).

Participant Flow:   Overall Study
    Zostavax™ Vaccine Group   Naturally-acquired VZV Immunity
STARTED   45   9 
COMPLETED   45   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zostavax™ Vaccine Group Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
Naturally-acquired VZV Immunity Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
Total Total of all reporting groups

Baseline Measures
   Zostavax™ Vaccine Group   Naturally-acquired VZV Immunity   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   9   54 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age       
40-49 Years Old      0   0.0%      9 100.0%      9  16.7% 
50 and above      45 100.0%      0   0.0%      45  83.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  46.7%      7  77.8%      28  51.9% 
Male      24  53.3%      2  22.2%      26  48.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3   6.7%      0   0.0%      3   5.6% 
Not Hispanic or Latino      40  88.9%      9 100.0%      49  90.7% 
Unknown or Not Reported      2   4.4%      0   0.0%      2   3.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2  22.2%      2   3.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      43  95.6%      7  77.8%      50  92.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   4.4%      0   0.0%      2   3.7% 
Region of Enrollment 
[Units: Participants]
     
United States   45   9   54 


  Outcome Measures

1.  Primary:   Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV   [ Time Frame: Day 0 to Day 35 ]

2.  Secondary:   Number of Participants With Related Adverse Events   [ Time Frame: 0 to 35 Days ]

3.  Other Pre-specified:   Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.   [ Time Frame: 0 to 14 Days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Cornelia Dekker
Organization: Stanford University School of Medicine, Dept. of Pediatrics
phone: 650-724-4437
e-mail: cdekker@stanford.edu


Publications:

Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT01911065     History of Changes
Other Study ID Numbers: SU-19385
1U19AI090019-01 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2013
First Posted: July 30, 2013
Results First Submitted: January 11, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 21, 2017