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;   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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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  
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
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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 ]
  Hide Outcome Measure 8

Measure Type Primary
Measure Title 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
Measure Description Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to vaccination and 10 days after the second vaccination  
Safety Issue No  

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.
Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.

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.

Measured Values
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
  55     57  
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  
[units: Participants]
  32     41  

No statistical analysis provided for 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



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


  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