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Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

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: NCT01262846
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infection
Intervention Biological: Fluzone®
Enrollment 195
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluzone SD Fluzone® High Dose
Hide Arm/Group Description

Fluzone® Standard dose

Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.

Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Period Title: Overall Study
Started 95 100
Completed 93 97
Not Completed 2 3
Arm/Group Title Fluzone SD Fluzone® High Dose Total
Hide Arm/Group Description

Fluzone® Standard dose

Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.

Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.

Total of all reporting groups
Overall Number of Baseline Participants 95 100 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 95 participants 100 participants 195 participants
46
(37 to 53)
44
(35 to 50)
45
(35 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 100 participants 195 participants
Female
22
  23.2%
36
  36.0%
58
  29.7%
Male
73
  76.8%
64
  64.0%
137
  70.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 100 participants 195 participants
Hispanic or Latino
7
   7.4%
3
   3.0%
10
   5.1%
Not Hispanic or Latino
88
  92.6%
97
  97.0%
185
  94.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 100 participants 195 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.1%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
58
  61.1%
78
  78.0%
136
  69.7%
White
36
  37.9%
22
  22.0%
58
  29.7%
More than one race
0
   0.0%
00
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Immunogenicity
Hide Description To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.
Time Frame Baseline to 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants except 5 participants with missing data at day 21
Arm/Group Title SD Recipients HD Recipients
Hide Arm/Group Description:
Fluzone Regular Dose
Fluzone High Dose
Overall Number of Participants Analyzed 93 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric Mean antibody titer
Baseline H1N1 (A/California/07/2009 X-179 A)
22
(14 to 37)
25
(15 to 40)
Week 3 H1N1 (A/California/07/2009 X-179 A)
344
(229 to 518)
686
(509 to 926)
Baseline H3N2 A/Victoria/210/2009 X-187
25
(16 to 42)
26
(16 to 42)
Week 3 H3N2 A/Victoria/210/2009 X-187
324
(227 to 464)
739
(529 to 1032)
Baseline B/Brisbane/60/2008 (influenza B)
17
(11 to 25)
20
(14 to 28)
Week 3 B/Brisbane/60/2008 (influenza B)
64
(46 to 91)
140
(110 to 178)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SD Recipients HD Recipients
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
SD Recipients HD Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SD Recipients HD Recipients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/95 (3.16%)      0/100 (0.00%)    
General disorders     
Hospitalization  1  3/95 (3.16%)  0/100 (0.00%) 
Death   0/95 (0.00%)  0/100 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
SD Recipients HD Recipients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/95 (76.84%)      90/100 (90.00%)    
Gastrointestinal disorders     
Diarrhea  2  1/95 (1.05%)  1 0/100 (0.00%)  0
Nausea   8/95 (8.42%)  8 7/100 (7.00%)  7
vomiting   1/95 (1.05%)  1 3/100 (3.00%)  3
General disorders     
Chills  1  3/95 (3.16%)  3 5/100 (5.00%)  5
Headache   9/95 (9.47%)  9 8/100 (8.00%)  8
Malaise  2  14/95 (14.74%)  14 13/100 (13.00%)  13
Infections and infestations     
Lymphadenopathy   1/95 (1.05%)  1 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/95 (3.16%)  3 5/100 (5.00%)  5
Myalgia   17/95 (17.89%)  17 19/100 (19.00%)  19
Skin and subcutaneous tissue disorders     
Pain * 1 [1]  4/95 (4.21%)  4 15/100 (15.00%)  15
Redness * 1 [1]  1/95 (1.05%)  1 3/100 (3.00%)  3
Induration * 1 [2]  1/95 (1.05%)  1 2/100 (2.00%)  2
Tenderness * 1 [2]  10/95 (10.53%)  10 10/100 (10.00%)  10
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA
2
Term from vocabulary, MedDRA
[1]
Local at injection site
[2]
Local
Caution The trial was not powered to determine clinical efficacy or to detect differences in the occurrence of less common adverse events.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pablo Tebas
Organization: University of Pennsylvania
Phone: 215-6626932
EMail: pablo.tebas@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01262846    
Other Study ID Numbers: UPenn FLU 02
First Submitted: December 16, 2010
First Posted: December 17, 2010
Results First Submitted: December 8, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017