We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992017
First Posted: October 8, 2009
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)
Results First Submitted: November 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: HIV Infections
H1N1 Influenza Virus
Intervention: Biological: Influenza A (H1N1) monovalent vaccine

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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) 
[1] This measures the number of CD4 cells.
Percentage of CD4 Cells [1] 
[Units: Percentage of CD4 cells]
Mean (Standard Deviation)
 30  (11) 
[1] This measures the percentage of CD4 cells.
Gestational Age [1] 
[Units: Weeks]
Mean (Standard Deviation)
 25  (6) 
[1] 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 ]

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 ]

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 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 ]

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 ]

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 ]

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 ]

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

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 ]

10.  Secondary:   Response to Seasonal Trivalent Influenza Vaccine (TIV)   [ Time Frame: Measured at entry ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information