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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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992836
First received: October 8, 2009
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
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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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
  Show All Outcome Measures

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

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 ]
  Show Outcome Measure 2

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

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 ]
  Hide Outcome Measure 4

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 endpoint titers measured 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 ]
  Show Outcome Measure 5

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

7.  Secondary:   Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values and Frequency of Cytotoxic T-cell Lymphocytes Specific for Novel H1N1 Influenza Virus   [ Time Frame: Measured after first and second doses, 21 days after first dose, and 10 days and 6 months after second dose ]
Results not yet posted.   Anticipated Posting Date:   02/2012   Safety Issue:   No

8.  Secondary:   HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)   [ Time Frame: Measured after first and second doses, 21 days after first dose, and 10 days and 6 months after second dose ]
Results not yet posted.   Anticipated Posting Date:   02/2012   Safety Issue:   No

9.  Secondary:   Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens   [ Time Frame: Measured after first and second doses, 21 days after first dose, and 10 days and 6 months after second dose ]
Results not yet posted.   Anticipated Posting Date:   02/2012   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992836     History of Changes
Other Study ID Numbers: P1088, 10840, IMPAACT P1088
Study First Received: October 8, 2009
Results First Received: August 23, 2011
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government