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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: December 2, 2014
Last verified: December 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 
Overall Participants Analyzed 
[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 
[1] Study participants were stratified by age into three groups.
CD4 Cells Count [1] 
[Units: Cells / mm^3]
Mean (Standard Deviation)
 568  (242) 
[1] This measures the number of CD4 cells.
Percentage of CD4 Cells [1] 
[Units: Percentage]
Mean (Standard Deviation)
 29  (11) 
[1] 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 ]

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
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Time Frame Adverse events were collected from the date of enrollment in the study until 6 months after second vaccination.
Additional Description Include Adverse Events (AEs) of All Grades, Including Abnormal Laboratory Values, Signs and Symptoms, or Diagnoses; Solicited Local AEs and Systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    All Study Participants
Total, other (not including serious) adverse events   
# participants affected / at risk   113/155 (72.90%) 
Ear and labyrinth disorders   
Ear pain † 1   
# participants affected / at risk   10/155 (6.45%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   11/155 (7.10%) 
Diarrhoea † 1   
# participants affected / at risk   16/155 (10.32%) 
Nausea † 1   
# participants affected / at risk   12/155 (7.74%) 
Vomiting † 1   
# participants affected / at risk   18/155 (11.61%) 
General disorders   
Adverse event † 1   
# participants affected / at risk   20/155 (12.90%) 
Fatigue † 1   
# participants affected / at risk   11/155 (7.10%) 
Pyrexia † 1   
# participants affected / at risk   19/155 (12.26%) 
Infections and infestations   
Otitis media † 1   
# participants affected / at risk   11/155 (7.10%) 
Investigations   
Alanine aminotransferase increased † 1   
# participants affected / at risk   11/155 (7.10%) 
Aspartate aminotransferase increased † 1   
# participants affected / at risk   9/155 (5.81%) 
Neutrophil count decreased † 1   
# participants affected / at risk   21/155 (13.55%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity † 1   
# participants affected / at risk   12/155 (7.74%) 
Nervous system disorders   
Headache † 1   
# participants affected / at risk   29/155 (18.71%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   51/155 (32.90%) 
Nasal congestion † 1   
# participants affected / at risk   35/155 (22.58%) 
Oropharyngeal pain † 1   
# participants affected / at risk   32/155 (20.65%) 
Rhinorrhoea † 1   
# participants affected / at risk   19/155 (12.26%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0



  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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  More Information