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The Influence of Chronic CMV Infection on Influenza Vaccine Responses (SLVP025)

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ClinicalTrials.gov Identifier: NCT02134184
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : December 26, 2016
Last Update Posted : February 23, 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: Basic Science
Conditions: Cytomegalovirus Infections
Influenza
Intervention: Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50

  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
CMV Negative Group

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

CMV Positive Group

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly

Recent CMV Converters

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the "recent" timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past


Participant Flow:   Overall Study
    CMV Negative Group   CMV Positive Group   Recent CMV Converters
STARTED   33   37   8 
COMPLETED   33   37   8 
NOT COMPLETED   0   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
CMV Negative Group

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

CMV Positive Group

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

Recent CMV Converters

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly

Total Total of all reporting groups

Baseline Measures
   CMV Negative Group   CMV Positive Group   Recent CMV Converters   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   37   8   78 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12  36.4%      16  43.2%      1  12.5%      29  37.2% 
>=65 years      21  63.6%      21  56.8%      7  87.5%      49  62.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.96  (4.52)   67.46  (5.26)   66.75  (3.53)   67.21  (4.80) 
Gender 
[Units: Participants]
Count of Participants
       
Female      10  30.3%      20  54.1%      7  87.5%      37  47.4% 
Male      23  69.7%      17  45.9%      1  12.5%      41  52.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      1   2.7%      0   0.0%      1   1.3% 
Not Hispanic or Latino      33 100.0%      36  97.3%      8 100.0%      77  98.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.0%      1   2.7%      0   0.0%      2   2.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      31  93.9%      36  97.3%      8 100.0%      75  96.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   3.0%      0   0.0%      0   0.0%      1   1.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   33   37   8   78 


  Outcome Measures

1.  Primary:   Number of Participants From Each Arm Who Received Influenza Vaccine   [ Time Frame: Day 0 to Day 28 ]

2.  Secondary:   Number of Participants With Related Adverse Events   [ Time Frame: Day 0 to Day 28 ]

3.  Other Pre-specified:   To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells   [ Time Frame: Day 0 to Day 28 ]
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



Responsible Party: Cornelia L. Dekker, Stanford University
ClinicalTrials.gov Identifier: NCT02134184     History of Changes
Other Study ID Numbers: SU-25199
1U19AI090019-01 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: December 16, 2016
Results First Posted: December 26, 2016
Last Update Posted: February 23, 2017