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H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992433
First received: October 8, 2009
Last updated: May 10, 2012
Last verified: February 2011
History of Changes
Results First Received: October 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inactivated Influenza H1N1 vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were HIV-positive adult males and females recruited from existing patient populations and from the communities at large around the clinical sites. Participants were enrolled between 19Nov2009 and 23Apr2010.

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
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Participant Flow:   Overall Study
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
STARTED     95     97  
COMPLETED     91     90  
NOT COMPLETED     4     7  



  Baseline Characteristics
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Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine     Total  
Number of Participants  
[units: participants]
 		  95     97     192  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     95     97     192  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.7  ± 9.9     45.3  ± 9.3     45.5  ± 9.6  
Gender  
[units: participants]
 		     
Female     19     22     41  
Male     76     75     151  
Region of Enrollment  
[units: participants]
 		     
United States     95     97     192  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first vaccination ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second vaccination ]
  Show Outcome Measure 4

5.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ]
  Show Outcome Measure 5

6.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]
  Show Outcome Measure 6

7.  Primary:   Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first vaccination ]
  Show Outcome Measure 7

8.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ]
  Show Outcome Measure 8

9.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second vaccination ]
  Show Outcome Measure 9

10.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ]
  Show Outcome Measure 10

11.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ]
  Show Outcome Measure 11

12.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]
  Show Outcome Measure 12

13.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 10 after the second vaccination ]
  Show Outcome Measure 13

14.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]
  Show Outcome Measure 14

15.  Primary:   Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]
  Show Outcome Measure 15

16.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to the first vaccination ]
  Show Outcome Measure 16

17.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 10 after the first vaccination ]
  Show Outcome Measure 17

18.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the first vaccination ]
  Show Outcome Measure 18

19.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 10 and Day 21 after the second vaccination ]
  Show Outcome Measure 19

20.  Primary:   Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]
  Show Outcome Measure 20

21.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days post first vaccination (Day 0-7). ]
  Show Outcome Measure 21

22.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days post second vaccination (Day 0-7). ]
  Show Outcome Measure 22

23.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Within 8 days post first vaccination (Day 0-7). ]
  Show Outcome Measure 23

24.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Within 8 days post second vaccination (Day 0-7). ]
  Show Outcome Measure 24

25.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination   [ Time Frame: Within 8 days post first vaccination (Day 0-7). ]
  Show Outcome Measure 25

26.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days post second vaccination (Day 0-7). ]
  Show Outcome Measure 26

27.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination   [ Time Frame: Within 8 days post first vaccination (Day 0-7). ]
  Show Outcome Measure 27

28.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days post second vaccination (Day 0-7). ]
  Show Outcome Measure 28

29.  Primary:   Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after the last vaccination ]
  Show Outcome Measure 29


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
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Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
15 Mcg H1N1 Vaccine 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
30 Mcg H1N1 Vaccine 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.

Other Adverse Events
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Total, other (not including serious) adverse events      
# participants affected / at risk     61/95     73/97  
Gastrointestinal disorders      
Diarrhoea * 1    
# participants affected / at risk     8/95 (8.42%)     5/97 (5.15%)  
# events     9     5  
Nausea † 1    
# participants affected / at risk     17/95 (17.89%)     13/97 (13.40%)  
# events     19     18  
General disorders      
Feeling hot † 1    
# participants affected / at risk     14/95 (14.74%)     14/97 (14.43%)  
# events     19     16  
Malaise † 1    
# participants affected / at risk     25/95 (26.32%)     28/97 (28.87%)  
# events     36     34  
Injection site pain † 1    
# participants affected / at risk     18/95 (18.95%)     30/97 (30.93%)  
# events     22     38  
Tenderness † 1 [4]    
# participants affected / at risk     25/95 (26.32%)     41/97 (42.27%)  
# events     30     56  
Injection site erythema † 1    
# participants affected / at risk     16/95 (16.84%)     17/97 (17.53%)  
# events     24     21  
Injection site swelling (functional grading) † 1 [5]    
# participants affected / at risk     13/95 (13.68%)     10/97 (10.31%)  
# events     17     13  
Injection site swelling (measured) † 1 [5]    
# participants affected / at risk     14/95 (14.74%)     10/97 (10.31%)  
# events     18     13  
Infections and infestations      
Upper respiratory tract infection * 1    
# participants affected / at risk     8/95 (8.42%)     8/97 (8.25%)  
# events     8     10  
Investigations      
Blood pressure increased * 1    
# participants affected / at risk     8/95 (8.42%)     6/97 (6.19%)  
# events     8     6  
Musculoskeletal and connective tissue disorders      
Myalgia † 1    
# participants affected / at risk     21/95 (22.11%)     24/97 (24.74%)  
# events     28     34  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     29/95 (30.53%)     33/97 (34.02%)  
# events     35     46  
Respiratory, thoracic and mediastinal disorders      
Oropharyngeal pain * 1    
# participants affected / at risk     0/95 (0.00%)     5/97 (5.15%)  
# events     0     5  
† Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0
[4] Tenderness was solicited as a reaction at the vaccination site.
[5] Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Hana El Sahly, MD
Organization: Baylor College of Medicine
phone: 713-798-2058
e-mail: hanae@bcm.edu


Publications of Results:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992433     History of Changes
Other Study ID Numbers: 09-0073, N01AI80002C
Study First Received: October 8, 2009
Results First Received: October 13, 2011
Last Updated: May 10, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board