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Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992836
First received: October 8, 2009
Last updated: October 29, 2014
Last verified: October 2014
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
H1N1 Influenza Virus
Intervention: Biological: Influenza A (H1N1) 2009 monovalent 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 enrolled from 37 sites between October 14, 2009 and November 12, 2009. Participants were stratified by age in three groups: >=4 to < 9 years old, >=9 to < 18 years old and >=18 to <25 years old.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One study participant was inadvertently enrolled with acute illness, was not given any vaccination and was immediately taken off study. A second study participant received the first vaccination but it was discovered that he/she was not compliant with the ARV regimen and was taken off study before receiving the second dose of vaccine.

Reporting Groups
  Description
All Study Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     155  
Received Both Study Vaccinations     150  
COMPLETED     150  
NOT COMPLETED     5  
Lost to Follow-up                 1  
Withdrawal by Subject                 2  
Protocol Violation                 2  



  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
All Study Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  155  
Age  
[units: years]
Mean ± Standard Deviation
  13  ± 6  
Gender  
[units: participants]
 
Female     76  
Male     79  
Region of Enrollment  
[units: participants]
 
United States     147  
Puerto Rico     8  
Age Strata [1]
[units: Participants]
 
>=4 to < 9 years old     54  
>=9 to < 18 years old     51  
>=18 to < 25 years old     50  
CD4 Cells Count [2]
[units: cells / mm^3]
Mean ± Standard Deviation
  568  ± 242  
Percentage of CD4 Cells [3]
[units: percentage]
Mean ± Standard Deviation
  29  ± 11  
[1] Study participants were stratified by age into three groups.
[2] This measures the number of CD4 cells.
[3] This measures the percentage of CD4 cells.



  Outcome Measures
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1.  Primary:   The Number of Participants Who Had at Least One Adverse Event (AE)   [ Time Frame: Measured up to 7 months after vaccination ]

2.  Primary:   The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine   [ Time Frame: Measured up to 7 months after vaccination ]

3.  Primary:   Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose   [ Time Frame: Measured at Day 21 ]

4.  Primary:   Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40   [ Time Frame: Measured at 21 days after first dose and 10 days after second dose ]
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Measure Type Primary
Measure Title Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40
Measure Description Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.
Time Frame Measured at 21 days after first dose and 10 days after second dose  
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.
The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.

Reporting Groups
  Description
Overall The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.

Measured Values
    Overall  
Number of Participants Analyzed  
[units: participants]
  142  
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40  
[units: percentage of participants]
Number ( 95% Confidence Interval )
 
Post dose 1 (N=140)     72.1  
  ( 63.9 to 79.4 )  
Post dose 2 (N=142)     82.4  
  ( 75.1 to 88.3 )  

No statistical analysis provided for Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40



5.  Secondary:   Percent of Participants With an HAI Titer >=40 at Long-term Follow-up   [ Time Frame: Measured at 6 months after second dose ]

6.  Secondary:   Geometric Mean Antibody Titers (GMT) HAI   [ Time Frame: Measured after first and second doses and 6 months after second dose ]

7.  Secondary:   Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days after second dose ]

8.  Secondary:   HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose ]

9.  Secondary:   Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days after second dose ]


  Serious Adverse Events


  Other Adverse Events


  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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