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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
Results First Received: October 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   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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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
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 
Overall Participants Analyzed 
[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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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). ]

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). ]

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

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

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). ]

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). ]

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). ]

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). ]

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


  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 (64.21%)   73/97 (75.26%) 
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.



  Limitations and Caveats
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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
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