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Trial record 37 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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.
ClinicalTrials.gov Identifier: NCT00992017
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : March 13, 2012
Last Update Posted : December 30, 2014
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)

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
Enrollment 130
Recruitment Details Pregnant women were enrolled from 31 sites between October 8, 2009 and November 13, 2009.
Pre-assignment Details Two study participants were enrolled but left the clinic before receiving any vaccination and they were taken off study.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Period Title: Overall Study
Started 128 [1]
Received Both Study Vaccinations 124
Received Only One Study Vaccination 4 [2]
Completed 118
Not Completed 10
Reason Not Completed
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
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
28  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
128
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants
United States 112
Puerto Rico 16
CD4 Cells Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells / mm^3
Number Analyzed 128 participants
504  (264)
[1]
Measure Description: This measures the number of CD4 cells.
Percentage of CD4 Cells   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of CD4 cells
Number Analyzed 128 participants
30  (11)
[1]
Measure Description: This measures the percentage of CD4 cells.
Gestational Age   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 128 participants
25  (6)
[1]
Measure Description: This shows the approximate gestational age at study entry.
1.Primary Outcome
Title The Number of Participants Who Had at Least One Adverse Event (AE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 128 pregnant women who received at least one vaccination are included in this analysis.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
Pregnant women enrolled in the study.
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: 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
2.Primary Outcome
Title The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
Hide Description Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 128 pregnant women who received at least one vaccination are included.
Arm/Group Title Vaccinated Study Participants
Hide Arm/Group Description:
Pregnant women who received at least one H1N1 vaccination.
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: Participants
0
3.Primary Outcome
Title Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Hide Description [Not Specified]
Time Frame Measured at Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
All 128 pregnant women who received at least one vaccination are included.
Arm/Group Title Vaccinated Study Participants
Hide Arm/Group Description:
Pregnant women who received at least one H1N1 vaccination.
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: Participants
0
4.Primary Outcome
Title Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40
Hide Description Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used 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 at 10 days after second dose of study vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of the eligible pregnant women with nonmissing HAI titers, who had not delivered prior to the evaluation, and had received all doses of vaccine up to that timepoint. The N for the analyses of HAI titers after the first and second vaccinations were 118 and 108, respectively.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
The pregnant women who received the H1N1 vaccinations.
Overall Number of Participants Analyzed 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
Percent with titers >= 40 post dose 1 (N=118)
73.7
(64.8 to 81.4)
Percent with titers >= 40 post dose 2 (N=108)
80.6
(71.8 to 87.5)
5.Secondary Outcome
Title Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery
Hide Description Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used 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 delivery of the baby, and at 3 months and 6 months after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of eligible pregnant women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for the analyses of HAI titers at delivery, and at 3 and 6 months after were 102, 92 and 58, respectively. Only some women had a clinic visit at 6 months post delivery.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
Pregnant women who received H1N1 vaccinations.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
% with titers >= 1:40 at delivery (N=102)
65.7
(55.6 to 74.8)
% with titers >= 1:40 at 3 mo post delivery (N=92)
55.4
(44.7 to 65.8)
% with titers >= 1:40 at 6 mo post delivery (N=58)
60.3
(46.6 to 73.0)
6.Secondary Outcome
Title Percent of Infants With an HAI Titer of >= 40
Hide Description Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used 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 birth (via cord blood) and at 3 months and 6 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.
Arm/Group Title Infants
Hide Arm/Group Description:
Infants born to pregnant women who received H1N1 vaccines.
Overall Number of Participants Analyzed 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
% infants with titers >= 1:40 at birth (N=96)
64.6
(54.2 to 74.1)
% infants with titers >= 1:40 at 3 months (N=87)
23.0
(14.6 to 33.2)
% infants with titers >= 1:40 at 6 months (N=52)
11.5
(4.4 to 23.4)
7.Secondary Outcome
Title Maternal Geometric Mean Titers (GMT) of Antibodies HAI
Hide Description Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.
Time Frame Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of eligible women with nonmissing HAI titers, who had not delivered before the evaluation post first or second dose, and received all vaccines up to that point, respectively. The N for analyses after the first and second vaccinations, at delivery, 3 and 6 months after were 104, 94, 102, 92 and 58, respectively.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
Pregnant women who received the H1N1 vaccines.
Overall Number of Participants Analyzed 104
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Post first vaccination (N=104)
83
(63 to 110)
Post second vaccination (N=94)
81
(62 to 106)
At delivery (N=102)
50
(39 to 65)
At 3 months post delivery (N=92)
36
(28 to 46)
At 6 months post delivery (N=58)
38
(29 to 50)
8.Secondary Outcome
Title Infant GMT of Antibodies HAI
Hide Description Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.
Time Frame Measured at birth and at 3 and 6 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.
Arm/Group Title Infants
Hide Arm/Group Description:
Infants born to pregnant women who received H1N1 vaccines.
Overall Number of Participants Analyzed 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: units on the HAI titer scale
At birth (N=96 infants)
56
(43 to 72)
At 3 months (N=87 infants)
13
(11 to 16)
At 6 months (N=52 infants)
14
(11 to 17)
9.Secondary Outcome
Title Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values
Hide Description The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.
Time Frame Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pregnant women who had not delivered prior to the evaluation, had received all doses of vaccine up to that timepoint and had sufficient samples for testing.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
The pregnant women who received the H1N1 vaccinations.
Overall Number of Participants Analyzed 45
Median (Inter-Quartile Range)
Unit of Measure: ASC or SFC/10^6 PBMC
IgG ASC/10^6 PBMC, Week 0 (N=36)
6
(2 to 28)
IgG ASC/10^6 PBMC, Post Dose 1 (N=36)
15
(4 to 46)
IgG ASC/10^6 PBMC, Post Dose 2 (N=39)
14
(6 to 70)
pH1N1 IFNgamma SFC/10^6 PBMC, Week 0 (N=45)
166
(38 to 324)
pH1N1 IFNgamma SFC/10^6 PBMC, Post Dose 1 (N=44)
117
(40 to 506)
pH1N1 IFNgamma SFC/10^6 PBMC, Post Dose 2 (N=43)
76
(32 to 336)
10.Secondary Outcome
Title Response to Seasonal Trivalent Influenza Vaccine (TIV)
Hide Description Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.
Time Frame Measured at entry
Hide Outcome Measure Data
Hide Analysis Population Description
Pregnant women who received the first H1N1 immunization.
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description:
Pregnant women who received the H1N1 vaccines.
Overall Number of Participants Analyzed 128
Median (Inter-Quartile Range)
Unit of Measure: titer
20
(10 to 40)
Time Frame Adverse events were collected from the date of enrollment in the study until 6 months after delivery.
Adverse Event Reporting 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.
 
Arm/Group Title H1N1 Vaccine
Hide Arm/Group Description Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
All-Cause Mortality
H1N1 Vaccine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
H1N1 Vaccine
Affected / at Risk (%)
Total   21/128 (16.41%) 
Gastrointestinal disorders   
Vomiting  1  1/128 (0.78%) 
General disorders   
Influenza like illness  1  1/128 (0.78%) 
Infections and infestations   
Pneumonia  1  1/128 (0.78%) 
Wound infection  1  1/128 (0.78%) 
Injury, poisoning and procedural complications   
Wound dehiscence  1  1/128 (0.78%) 
Musculoskeletal and connective tissue disorders   
Flank pain  1  1/128 (0.78%) 
Nervous system disorders   
Hypoaesthesia  1  1/128 (0.78%) 
Paraesthesia  1  1/128 (0.78%) 
VIIth nerve paralysis  1  1/128 (0.78%) 
Pregnancy, puerperium and perinatal conditions   
Complication of pregnancy  1  1/128 (0.78%) 
Intra-uterine death  1  1/128 (0.78%) 
Placenta accreta  1  1/128 (0.78%) 
Pre-eclampsia  1  5/128 (3.91%) 
Premature labour  1  3/128 (2.34%) 
Premature rupture of membranes  1  1/128 (0.78%) 
Psychiatric disorders   
Conversion disorder  1  1/128 (0.78%) 
Vascular disorders   
Deep vein thrombosis  1  1/128 (0.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
H1N1 Vaccine
Affected / at Risk (%)
Total   118/128 (92.19%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  9/128 (7.03%) 
Gastrointestinal disorders   
Abdominal pain  1  12/128 (9.38%) 
Diarrhoea  1  11/128 (8.59%) 
Nausea  1  24/128 (18.75%) 
Vomiting  1  15/128 (11.72%) 
General disorders   
Fatigue  1  9/128 (7.03%) 
Pyrexia  1  8/128 (6.25%) 
Infections and infestations   
Bacterial disease carrier  1  7/128 (5.47%) 
Vaginitis bacterial  1  8/128 (6.25%) 
Vulvovaginal candidiasis  1  16/128 (12.50%) 
Investigations   
Alanine aminotransferase increased  1  10/128 (7.81%) 
Aspartate aminotransferase increased  1  8/128 (6.25%) 
Blood albumin abnormal  1  30/128 (23.44%) 
Blood alkaline phosphatase increased  1  7/128 (5.47%) 
Blood bicarbonate abnormal  1  14/128 (10.94%) 
Blood glucose decreased  1  16/128 (12.50%) 
Blood sodium decreased  1  25/128 (19.53%) 
Haemoglobin decreased  1  21/128 (16.41%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  11/128 (8.59%) 
Pain in extremity  1  11/128 (8.59%) 
Nervous system disorders   
Dizziness  1  9/128 (7.03%) 
Headache  1  31/128 (24.22%) 
Pregnancy, puerperium and perinatal conditions   
Pre-eclampsia  1  7/128 (5.47%) 
Reproductive system and breast disorders   
Vaginal discharge  1  19/128 (14.84%) 
Vaginal haemorrhage  1  9/128 (7.03%) 
Vulvovaginal pruritus  1  11/128 (8.59%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  22/128 (17.19%) 
Nasal congestion  1  18/128 (14.06%) 
Oropharyngeal pain  1  11/128 (8.59%) 
Skin and subcutaneous tissue disorders   
Rash  1  7/128 (5.47%) 
Vascular disorders   
Hypertension  1  11/128 (8.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: 919-405-1429
Publications of Results:
S. Nachman, A. Weinberg, P. Muresan, M. Abzug, R. Ebiasah, E. Petzold, B. Heckman, H. Watts, J. Miller and M. Levin Safety of an Inactivated Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 vaccine) in HIV-1 Infected Pregnant Women, P1086. Presented at the Retroviruses Conference, Feb 2010
Weinberg A, Muresan P, Fenton T, Handelsman E, Watts H, Miller J, Heckman B, Bloom A, Ebiasah R, Petzold E, Levy W, Abzug M, Levin M and Nachman S for IMPAACT P1086 Team: Safety and Immunogenicity of Two Doses of Monovalent Pandemic H1N1 (pH1N1) Influenza Vaccine in HIV-Infected Pregnant Women. Presented at the IDSA conference, October 2010.
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00992017     History of Changes
Other Study ID Numbers: P1086
10835 ( Registry Identifier: DAIDS ES Registry Number )
IMPAACT P1086
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: November 7, 2011
Results First Posted: March 13, 2012
Last Update Posted: December 30, 2014