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Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

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:
NCT00992017
First received: October 7, 2009
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
Results First Received: November 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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) 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
Pregnant women were enrolled from 31 sites between October 8, 2009 and November 13, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two study participants were enrolled but left the clinic before receiving any vaccination and they were taken off study.

Reporting Groups
  Description
H1N1 Vaccine Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Participant Flow:   Overall Study
    H1N1 Vaccine  
STARTED     128 [1]
Received Both Study Vaccinations     124  
Received Only One Study Vaccination     4 [2]
COMPLETED     118  
NOT COMPLETED     10  
Lost to Follow-up                 2  
Withdrawal by Subject                 2  
Unable to get to clinic                 5  
Not adhere to study requirements                 1  
[1] Two additional women were enrolled but left the clinic before vaccine was administered.
[2] Reasons: delivered and LFU; moved; no transportation; ineligible - blood transfusion at delivery



  Baseline Characteristics
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Reporting Groups
  Description
H1N1 Vaccine Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Baseline Measures
    H1N1 Vaccine  
Number of Participants  
[units: participants]
 		  128  
Age  
[units: years]
Mean ± Standard Deviation 		  28  ± 6  
Gender  
[units: participants]
 		 
Female     128  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     112  
Puerto Rico     16  
CD4 Cells Count [1]
[units: cells / mm^3]
Mean ± Standard Deviation 		  504  ± 264  
Percentage of CD4 Cells [2]
[units: percentage of CD4 cells]
Mean ± Standard Deviation 		  30  ± 11  
Gestational Age [3]
[units: Weeks]
Mean ± Standard Deviation 		  25  ± 6  
[1] This measures the number of CD4 cells.
[2] This measures the percentage of CD4 cells.
[3] This shows the approximate gestational age at study entry.



  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 6 months after delivery ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title The Number of Participants Who Had at Least One Adverse Event (AE)
Measure Description Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited 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.
Time Frame Measured up to 6 months after delivery  
Safety Issue Yes  

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.
All 128 pregnant women who received at least one vaccination are included in this analysis.

Reporting Groups
  Description
H1N1 Vaccine Pregnant women enrolled in the study.

Measured Values
    H1N1 Vaccine  
Number of Participants Analyzed  
[units: participants]
 		  128  
The Number of Participants Who Had at Least One Adverse Event (AE)  
[units: Participants]
 		 
Overall (New AEs after start of treatment)     118  
Grade 4 AEs (New, after start of treatment)     11  
Grade 3 AEs (New, after start of treatment)     8  
Grade >=2 local and systemic AEs to injection     0  

No statistical analysis provided for The Number of Participants Who Had at Least One Adverse Event (AE)



2.  Primary:   The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine   [ Time Frame: Measured up to 6 months after delivery ]
  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 Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40   [ Time Frame: Measured at 21 days after first dose and at 10 days after second dose of study vaccine ]
  Show Outcome Measure 4

5.  Secondary:   Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery   [ Time Frame: Measured at delivery of the baby, and at 3 months and 6 months after delivery ]
  Show Outcome Measure 5

6.  Secondary:   Percent of Infants With an HAI Titer of >= 40   [ Time Frame: Measured at birth (via cord blood) and at 3 months and 6 months of age ]
  Show Outcome Measure 6

7.  Secondary:   Maternal Geometric Mean Titers (GMT) of Antibodies HAI   [ Time Frame: Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery ]
  Show Outcome Measure 7

8.  Secondary:   Infant GMT of Antibodies HAI   [ Time Frame: Measured at birth and at 3 and 6 months of age ]
  Show Outcome Measure 8

9.  Secondary:   Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values   [ Time Frame: Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose, and at 3 months after delivery ]
Results not yet posted.   Anticipated Posting Date:   07/2012   Safety Issue:   No

10.  Secondary:   Response to Seasonal Trivalent Influenza Vaccine (TIV)   [ Time Frame: Measured at entry ]
Results not yet posted.   Anticipated Posting Date:   07/2012   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:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992017     History of Changes
Other Study ID Numbers: P1086, 10835, IMPAACT P1086
Study First Received: October 7, 2009
Results First Received: November 7, 2011
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government