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

Primary Purpose

HIV Infections, H1N1 Influenza Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Influenza A (H1N1) monovalent vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccine, Pregnant, Perinatal

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria for Step I:

  • Confirmed diagnosis of HIV-1 infection
  • Pregnant
  • Between 14 and 35 weeks of gestation
  • Documented platelet count of greater than 50,000 mm3 and an absolute neutrophil count (ANC) of greater than 500 mm3 within 28 days prior to study entry
  • Able to understand and comply with planned study procedures
  • On antiretroviral therapy (ART) as outlined in the treatment guidelines for pregnant HIV-1 infected women. Women must be currently taking ART or should initiate ART either prior to or concomitantly with the first dose of the vaccine.

Inclusion Criteria for Step II:

  • Received the first dose of influenza A (H1N1) 2009 monovalent vaccine
  • Has a documented platelet count of greater than 50,000 mm3 and an ANC of greater than 500 mm3 within the 28 days prior to Step II entry

Exclusion Criteria for Step I:

  • Has a known allergy to eggs, egg products, neomycin, or polymyxin
  • Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV
  • Participation in a novel H1N1 influenza vaccine study in the past 2 years
  • Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel influenza H1N1 infection or positive influenza diagnostic test since June 2009 (specificity to H1N1 not required) prior to study entry
  • Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry
  • Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study or expects to receive another nonlicensed agent before delivery
  • Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry
  • Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
  • Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus [HPV]-related cervical dysplasia, and cervical intraepithelial neoplasia [CIN] Grades 1, 2, or 3)
  • Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months. Nasal and topical steroids are allowed.
  • Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to enrollment in this study
  • Current diagnosis of uncontrolled major psychiatric disorder
  • History of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children)
  • Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes (DTRs) in both legs (all four absent) within the past 6 months
  • Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) within the past 6 months
  • Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Pregnancy complications such as preterm labor, hypertension and pre-eclampsia are not exclusion criteria for this study.

Exclusion Criteria for Step II:

  • Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since the study vaccine dose #1 or expects to receive another nonlicensed agent before delivery
  • Use of anti-cancer chemotherapy or radiation therapy since study vaccine dose #1, new diagnosis of an active malignancy, or is immunosuppressed as a result of an underlying illness (other than HIV-1 infection) or treatment
  • Use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) for more than 2 consecutive weeks (or 2 weeks total) since study vaccine dose #1. Nasal and topical steroids are allowed.
  • Received immunoglobulin or other blood products (with exception of Rho D immune globulin) since study vaccine dose #1
  • A new diagnosis of uncontrolled major psychiatric disorder since study vaccine dose #1
  • New occurrence or new awareness of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children) since study vaccine dose #1
  • A new onset of a neurological disorder including (but not limited to) absent ankle and patellar DTRs in both legs (all four absent) since study vaccine dose #1
  • Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) since study vaccine dose #1
  • Any Grade 3 toxicity or AE experienced by a participant unless the investigator has received protocol team approval
  • Any Grade 4 toxicity or AE (other than injection site reaction or fever) that is definitely, probably, or possibly related to the study vaccine dose #1
  • Any Grade 4 injection site reactions or fever experienced by a subject, unless the investigator has received protocol team approval
  • Any Grade 4 AEs that are definitely not or probably not related to study vaccine, unless the investigator has received protocol team approval
  • Any new clinical findings since the study vaccine dose #1, that, in the investigator's opinion, would compromise the safety of the participant
  • Participant refuses further vaccination. The subject will still be asked to complete safety visits and be followed in the study.
  • Participant withdraws consent. Participants may withdraw their consent for study participation at any time and for any reason, without penalty.

Sites / Locations

  • Usc La Nichd Crs
  • University of California, UC San Diego CRS
  • Miller Children's Hosp. Long Beach CA NICHD CRS
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Univ. of California San Francisco NICHD CRS
  • Univ. of Colorado Denver NICHD CRS
  • Washington Hosp. Ctr. NICHD CRS
  • South Florida CDTC Ft Lauderdale NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Pediatric Perinatal HIV Clinical Trials Unit CRS
  • USF - Tampa NICHD CRS
  • Rush Univ. Cook County Hosp. Chicago NICHD CRS
  • Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS
  • Tulane Univ. New Orleans NICHD CRS
  • Johns Hopkins Univ. Baltimore NICHD CRS
  • Children's Hosp. of Boston NICHD CRS
  • Boston Medical Center Ped. HIV Program NICHD CRS
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Rutgers - New Jersey Medical School CRS
  • Bronx-Lebanon CRS
  • Jacobi Med. Ctr. Bronx NICHD CRS
  • Metropolitan Hosp. NICHD CRS
  • Columbia IMPAACT CRS
  • SUNY Stony Brook NICHD CRS
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Jude Children's Research Hospital CRS
  • Texas Children's Hospital CRS
  • Seattle Children's Research Institute CRS
  • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
  • San Juan City Hosp. PR NICHD CRS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H1N1 vaccine

Arm Description

Pregnant women enrolled received two doses of H1N1 vaccine, administered 21 days apart.

Outcomes

Primary Outcome Measures

The Number of Participants Who Had at Least One Adverse Event (AE)
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.
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
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.
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40
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.

Secondary Outcome Measures

Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery
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.
Percent of Infants With an HAI Titer of >= 40
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.
Maternal Geometric Mean Titers (GMT) of Antibodies HAI
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.
Infant GMT of Antibodies HAI
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.
Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values
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.
Response to Seasonal Trivalent Influenza Vaccine (TIV)
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.

Full Information

First Posted
October 7, 2009
Last Updated
November 3, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00992017
Brief Title
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Official Title
A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.
Detailed Description
On June 11, 2009, the World Health Organization declared a pandemic of the new H1N1 influenza virus, after the virus had caused significant fevers and respiratory illnesses in Mexico and the United States. Pregnant women are at an increased risk of complications from influenza. HIV infected people tend to have lower than normal antibody responses to seasonal influenza vaccines. Data suggest that larger than average doses of a vaccine counteract a weak antibody response. Preliminary results from ongoing studies of influenza A (H1N1) 2009 monovalent vaccines indicate that the vaccine may increase immune activation. This study tested the safety and antibody response of high doses of the influenza A (H1N1) 2009 monovalent vaccine in pregnant women infected with HIV. Participation in this study lasted until 6 months after participants had delivered their babies or up to 52 weeks. Participants received two doses of the H1N1 vaccine at study entry and after 21 days. Each dose consisted of two intramuscular injections (four total injections). On the days of the injections, participants had their babies' heart rates checked before and after vaccination. At these visits, and at follow-up visits on Days 21, 31, and 42, participants completed a review of symptoms, physical and neurological exams, and a blood draw. For 10 days after receiving each dose of the vaccine, participants were asked to keep track of their temperatures and symptoms or reactions in a journal. Participants were contacted on Day 2 and Day 10 after the first dose of vaccine was given and on Day 2 after the second dose of vaccine was given. Some participants also received a phone call after 6 months. At delivery of each participant's baby, blood was drawn from both the mother and umbilical cord (or from the baby if the cord blood could not be obtained). At 3 and 6 months after delivery, participants came in for follow-up visits involving, for both mother and child, a review of symptoms, brief physical exams, and blood draws (at 6 months only some women had a clinic visit, the rest received a phone call).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, H1N1 Influenza Virus
Keywords
Vaccine, Pregnant, Perinatal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H1N1 vaccine
Arm Type
Experimental
Arm Description
Pregnant women enrolled received two doses of H1N1 vaccine, administered 21 days apart.
Intervention Type
Biological
Intervention Name(s)
Influenza A (H1N1) monovalent vaccine
Intervention Description
Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart
Primary Outcome Measure Information:
Title
The Number of Participants Who Had at Least One Adverse Event (AE)
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
Title
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
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
Title
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Time Frame
Measured at Day 21
Title
Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40
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
Secondary Outcome Measure Information:
Title
Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery
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
Title
Percent of Infants With an HAI Titer of >= 40
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
Title
Maternal Geometric Mean Titers (GMT) of Antibodies HAI
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
Title
Infant GMT of Antibodies HAI
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
Title
Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values
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
Title
Response to Seasonal Trivalent Influenza Vaccine (TIV)
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Step I: Confirmed diagnosis of HIV-1 infection Pregnant Between 14 and 35 weeks of gestation Documented platelet count of greater than 50,000 mm3 and an absolute neutrophil count (ANC) of greater than 500 mm3 within 28 days prior to study entry Able to understand and comply with planned study procedures On antiretroviral therapy (ART) as outlined in the treatment guidelines for pregnant HIV-1 infected women. Women must be currently taking ART or should initiate ART either prior to or concomitantly with the first dose of the vaccine. Inclusion Criteria for Step II: Received the first dose of influenza A (H1N1) 2009 monovalent vaccine Has a documented platelet count of greater than 50,000 mm3 and an ANC of greater than 500 mm3 within the 28 days prior to Step II entry Exclusion Criteria for Step I: Has a known allergy to eggs, egg products, neomycin, or polymyxin Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV Participation in a novel H1N1 influenza vaccine study in the past 2 years Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel influenza H1N1 infection or positive influenza diagnostic test since June 2009 (specificity to H1N1 not required) prior to study entry Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study or expects to receive another nonlicensed agent before delivery Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection) Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus [HPV]-related cervical dysplasia, and cervical intraepithelial neoplasia [CIN] Grades 1, 2, or 3) Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months. Nasal and topical steroids are allowed. Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to enrollment in this study Current diagnosis of uncontrolled major psychiatric disorder History of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children) Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes (DTRs) in both legs (all four absent) within the past 6 months Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) within the past 6 months Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. Pregnancy complications such as preterm labor, hypertension and pre-eclampsia are not exclusion criteria for this study. Exclusion Criteria for Step II: Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since the study vaccine dose #1 or expects to receive another nonlicensed agent before delivery Use of anti-cancer chemotherapy or radiation therapy since study vaccine dose #1, new diagnosis of an active malignancy, or is immunosuppressed as a result of an underlying illness (other than HIV-1 infection) or treatment Use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) for more than 2 consecutive weeks (or 2 weeks total) since study vaccine dose #1. Nasal and topical steroids are allowed. Received immunoglobulin or other blood products (with exception of Rho D immune globulin) since study vaccine dose #1 A new diagnosis of uncontrolled major psychiatric disorder since study vaccine dose #1 New occurrence or new awareness of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children) since study vaccine dose #1 A new onset of a neurological disorder including (but not limited to) absent ankle and patellar DTRs in both legs (all four absent) since study vaccine dose #1 Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) since study vaccine dose #1 Any Grade 3 toxicity or AE experienced by a participant unless the investigator has received protocol team approval Any Grade 4 toxicity or AE (other than injection site reaction or fever) that is definitely, probably, or possibly related to the study vaccine dose #1 Any Grade 4 injection site reactions or fever experienced by a subject, unless the investigator has received protocol team approval Any Grade 4 AEs that are definitely not or probably not related to study vaccine, unless the investigator has received protocol team approval Any new clinical findings since the study vaccine dose #1, that, in the investigator's opinion, would compromise the safety of the participant Participant refuses further vaccination. The subject will still be asked to complete safety visits and be followed in the study. Participant withdraws consent. Participants may withdraw their consent for study participation at any time and for any reason, without penalty.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Nachman, MD
Organizational Affiliation
State University of New York at Stony Brook
Official's Role
Study Chair
Facility Information:
Facility Name
Usc La Nichd Crs
City
Alhambra
State/Province
California
ZIP/Postal Code
91803
Country
United States
Facility Name
University of California, UC San Diego CRS
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0672
Country
United States
Facility Name
Miller Children's Hosp. Long Beach CA NICHD CRS
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
Facility Name
Univ. of California San Francisco NICHD CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington Hosp. Ctr. NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Florida CDTC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pediatric Perinatal HIV Clinical Trials Unit CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
USF - Tampa NICHD CRS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush Univ. Cook County Hosp. Chicago NICHD CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614-3393
Country
United States
Facility Name
Tulane Univ. New Orleans NICHD CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Univ. Baltimore NICHD CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Children's Hosp. of Boston NICHD CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center Ped. HIV Program NICHD CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Rutgers - New Jersey Medical School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx-Lebanon CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Jacobi Med. Ctr. Bronx NICHD CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Metropolitan Hosp. NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Children's Research Hospital CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-3678
Country
United States
Facility Name
Texas Children's Hospital CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Seattle Children's Research Institute CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19423869
Citation
Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team; Dawood FS, Jain S, Finelli L, Shaw MW, Lindstrom S, Garten RJ, Gubareva LV, Xu X, Bridges CB, Uyeki TM. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Jun 18;360(25):2605-15. doi: 10.1056/NEJMoa0903810. Epub 2009 May 7. Erratum In: N Engl J Med. 2009 Jul 2;361(1):102.
Results Reference
background
PubMed Identifier
19643469
Citation
Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, Lindstrom S, Louie JK, Christ CM, Bohm SR, Fonseca VP, Ritger KA, Kuhles DJ, Eggers P, Bruce H, Davidson HA, Lutterloh E, Harris ML, Burke C, Cocoros N, Finelli L, MacFarlane KF, Shu B, Olsen SJ; Novel Influenza A (H1N1) Pregnancy Working Group. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet. 2009 Aug 8;374(9688):451-8. doi: 10.1016/S0140-6736(09)61304-0. Epub 2009 Jul 28.
Results Reference
background
Citation
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
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
23378284
Citation
Abzug MJ, Nachman SA, Muresan P, Handelsman E, Watts DH, Fenton T, Heckman B, Petzold E, Weinberg A, Levin MJ; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team. Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women. Clin Infect Dis. 2013 May;56(10):1488-97. doi: 10.1093/cid/cit057. Epub 2013 Feb 1.
Results Reference
derived
Links:
URL
http://www.impaactgroup.org
Description
Click here for information on the IMPAACT group and for the package insert on the H1N1 vaccine.
URL
http://www.cdc.gov/H1N1FLU
Description
Click here for updated results from clinical trials regarding H1N1 influenza.
URL
http://rsc.tech-res.com/safetyandpharmacovigilance/gradingtables.aspx
Description
Click here for the table used for grading toxicities: DAIDS Grading Severity of AEs, V1.0, Dec04

Learn more about this trial

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

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