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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: December 8, 2014
Last verified: December 2014
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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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
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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
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Time Frame Adverse events were collected from the date of enrollment in the study until 6 months after delivery.
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
H1N1 Vaccine Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Other Adverse Events
    H1N1 Vaccine
Total, other (not including serious) adverse events   
# participants affected / at risk   118/128 (92.19%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia † 1   
# participants affected / at risk   9/128 (7.03%) 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   12/128 (9.38%) 
Diarrhoea † 1   
# participants affected / at risk   11/128 (8.59%) 
Nausea † 1   
# participants affected / at risk   24/128 (18.75%) 
Vomiting † 1   
# participants affected / at risk   15/128 (11.72%) 
General disorders   
Fatigue † 1   
# participants affected / at risk   9/128 (7.03%) 
Pyrexia † 1   
# participants affected / at risk   8/128 (6.25%) 
Infections and infestations   
Bacterial disease carrier † 1   
# participants affected / at risk   7/128 (5.47%) 
Vaginitis bacterial † 1   
# participants affected / at risk   8/128 (6.25%) 
Vulvovaginal candidiasis † 1   
# participants affected / at risk   16/128 (12.50%) 
Investigations   
Alanine aminotransferase increased † 1   
# participants affected / at risk   10/128 (7.81%) 
Aspartate aminotransferase increased † 1   
# participants affected / at risk   8/128 (6.25%) 
Blood albumin abnormal † 1   
# participants affected / at risk   30/128 (23.44%) 
Blood alkaline phosphatase increased † 1   
# participants affected / at risk   7/128 (5.47%) 
Blood bicarbonate abnormal † 1   
# participants affected / at risk   14/128 (10.94%) 
Blood glucose decreased † 1   
# participants affected / at risk   16/128 (12.50%) 
Blood sodium decreased † 1   
# participants affected / at risk   25/128 (19.53%) 
Haemoglobin decreased † 1   
# participants affected / at risk   21/128 (16.41%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1   
# participants affected / at risk   11/128 (8.59%) 
Pain in extremity † 1   
# participants affected / at risk   11/128 (8.59%) 
Nervous system disorders   
Dizziness † 1   
# participants affected / at risk   9/128 (7.03%) 
Headache † 1   
# participants affected / at risk   31/128 (24.22%) 
Pregnancy, puerperium and perinatal conditions   
Pre-eclampsia † 1   
# participants affected / at risk   7/128 (5.47%) 
Reproductive system and breast disorders   
Vaginal discharge † 1   
# participants affected / at risk   19/128 (14.84%) 
Vaginal haemorrhage † 1   
# participants affected / at risk   9/128 (7.03%) 
Vulvovaginal pruritus † 1   
# participants affected / at risk   11/128 (8.59%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1   
# participants affected / at risk   22/128 (17.19%) 
Nasal congestion † 1   
# participants affected / at risk   18/128 (14.06%) 
Oropharyngeal pain † 1   
# participants affected / at risk   11/128 (8.59%) 
Skin and subcutaneous tissue disorders   
Rash † 1   
# participants affected / at risk   7/128 (5.47%) 
Vascular disorders   
Hypertension † 1   
# participants affected / at risk   11/128 (8.59%) 
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