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Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

Primary Purpose

HIV Infections, H1N1 Influenza Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Influenza A (H1N1) 2009 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 Influenza A Virus, H1N1 Subtype, Vaccine, Children, Adolescents, HIV-Infected, Perinatal HIV Infection, Treatment experienced

Eligibility Criteria

4 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Step I:

  • HIV infected
  • HIV-1 was perinatally acquired, in the opinion of the investigator
  • Participants receiving antiretrovirals (ARVs) must have been receiving a stable regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry
  • Participants not receiving ARVs at entry must not have received ARVs within 90 days prior to entry and must NOT plan to initiate ARVs within 60 days following study entry
  • Ability to complete all study immunizations and evaluations, in the opinion of the investigator
  • Agrees to use contraception, if necessary
  • Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil count (ANC) of more than 500 per mm3 within the 30 days prior to study entry
  • Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or participants who are emancipated minors must provide informed consent

Inclusion Criteria for Step II:

  • Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21 days ago
  • Documented platelet count of more than 50,000 per mm3 and an ANC of more than 500 per mm3 within the 30 days prior to Step II entry
  • If a woman became pregnant after Dose #1, she must be at more than 14 weeks of gestation and have her obstetrician's permission to receive the vaccine

Exclusion Criteria for Step I:

  • Pregnancy
  • Known allergy to egg protein (egg or egg product) or other components in the vaccines (these may include, but are not limited to: neomycin and polymyxin)
  • History, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal influenza vaccines that would contraindicate receipt of any influenza vaccine.
  • History of probable or proven pandemic 2009 Influenza A (H1N1) infection prior to study entry
  • Has received any live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry
  • Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to study entry or expects to receive another nonlicensed agent during the course of the study
  • Has an acute illness or a documented temperature greater than or equal to 100.0 degrees Fahrenheit within 24 hours prior to study entry
  • Use of anti-cancer chemotherapy or radiation therapy within the 36 months preceding study entry or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
  • Has an active neoplastic disease
  • Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks in the past 6 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. Nasal and topical steroids are allowed.
  • Has received immunoglobulin or other blood products within the 3 months prior to study entry
  • History of Guillain-Barre syndrome in the subject or subject's family, including parents, siblings, half-siblings, and children
  • Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes 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 within the past 6 months
  • Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Exclusion Criteria for Step II:

  • Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since Dose #1 or expects to receive another nonlicensed agent before the end of the study
  • Use of anti-cancer chemotherapy or radiation therapy since 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 steroids (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks since vaccine Dose #1 or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) since Dose #1 (nasal and topical steroids are allowed)
  • Has received immunoglobulin or other blood products since Dose #1
  • Any Grade 3 toxicity or adverse event (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 study vaccine
  • Any Grade 4 injection site reactions or fever experienced by a participant, 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
  • New occurrence or new awareness of Guillain-Barre syndrome in the participant or participant's family (parents, siblings, half-siblings, or children) since Dose #1
  • New onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes in both legs (all four absent) since Dose #1
  • Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) since Dose #1
  • Documented infection with 2009 Influenza A (H1N1) since Dose #1
  • Refusal of further vaccination by participant, parent, or guardian
  • Development of any new disease that the investigator judges to be clinically significant or clinically significant findings since Dose #1 that, in the investigator's opinion, would compromise the safety of the subject
  • Withdrawal of consent. Consent may be withdrawn at any time and for any reason, without penalty.

Sites / Locations

  • UAB Pediatric Infectious Diseases CRS
  • 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
  • Harbor UCLA Medical Ctr. NICHD CRS
  • Univ. of Colorado Denver NICHD CRS
  • Children's National Med. Ctr. Washington DC NICHD CRS
  • Howard Univ. Washington DC 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
  • Univ. of Maryland Baltimore 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
  • Children's Hospital of Michigan NICHD CRS
  • Rutgers - New Jersey Medical School CRS
  • Bronx-Lebanon CRS
  • Jacobi Med. Ctr. Bronx NICHD CRS
  • Nyu Ny Nichd Crs
  • Metropolitan Hosp. NICHD CRS
  • Columbia IMPAACT CRS
  • Strong Memorial Hospital Rochester NY NICHD 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

Influenza A (H1N1) 2009 monovalent vaccine

Arm Description

All participants received two doses of the H1N1 influenza virus 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. The AEs 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 Participants With a Hemagglutinin 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 Participants With an HAI Titer >=40 at Long-term Follow-up
Geometric Mean Antibody Titers (GMT) HAI
Presents the value of the geometric mean titer at each time point.
Cell-mediated Immune Responses, 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 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.
HAI Titers Against Seasonal Influenza Viruses Containing 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.
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens
The TIV assay was not performed due to lack of available cells after completion of other planned assays. The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC). The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC. The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC.

Full Information

First Posted
October 8, 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
NCT00992836
Brief Title
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Official Title
A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Perinatally Infected Children and Youth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 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
Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
Detailed Description
The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health Organization, due to the sustained community outbreaks seen in the United States and Mexico. Based on preliminary data, it appears children and young adults were particularly at risk of the H1N1 virus. People infected with HIV were also more susceptible to severe influenza infections than those who are uninfected. Children with HIV infection, then, have a compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with the development of higher levels of serum antibodies, which are needed to resist infection. Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations. This study tested the safety and immune response of HIV infected children and youth to a high dose of a vaccine for the new H1N1 influenza virus. Participation in this study lasted 7 months and had two steps. The first step involved receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days later, involved receiving the second dose of vaccine. Each dose of vaccine was delivered via two intramuscular shots (four total injections). After receiving each dose of the vaccine, participants were given a diary to record any symptoms or reactions. Participants were stratified into three groups by age, including 4 to 9 years, 9 to 18 years, and 18 to 25 years. Participants completed five scheduled visits, taking place at screening, study entry, Days 21 and 31, and after 7 months. Measurements taken on these visits included a medical history, physical and neurological exams, a blood draw, and, when applicable, a pregnancy test. In addition to these visits, participants received up to three additional phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days after the second dose of vaccine to check for reactions to the vaccine.

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
Influenza A Virus, H1N1 Subtype, Vaccine, Children, Adolescents, HIV-Infected, Perinatal HIV Infection, Treatment experienced

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Influenza A (H1N1) 2009 monovalent vaccine
Arm Type
Experimental
Arm Description
All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.
Intervention Type
Biological
Intervention Name(s)
Influenza A (H1N1) 2009 monovalent vaccine
Intervention Description
Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
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. The AEs 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 7 months after vaccination
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 7 months after vaccination
Title
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Time Frame
Measured at Day 21
Title
Percent of Participants With a Hemagglutinin 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 10 days after second dose
Secondary Outcome Measure Information:
Title
Percent of Participants With an HAI Titer >=40 at Long-term Follow-up
Time Frame
Measured at 6 months after second dose
Title
Geometric Mean Antibody Titers (GMT) HAI
Description
Presents the value of the geometric mean titer at each time point.
Time Frame
Measured after first and second doses and 6 months after second dose
Title
Cell-mediated Immune Responses, 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 peripheral blood mononucleated cell (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, 21 days after first dose, and 10 days after second dose
Title
HAI Titers Against Seasonal Influenza Viruses Containing 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, 21 days after first dose, and 10 days and 6 months after second dose
Title
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens
Description
The TIV assay was not performed due to lack of available cells after completion of other planned assays. The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC). The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC. The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC.
Time Frame
Measured at entry, 21 days after first dose, and 10 days after second dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Step I: HIV infected HIV-1 was perinatally acquired, in the opinion of the investigator Participants receiving antiretrovirals (ARVs) must have been receiving a stable regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry Participants not receiving ARVs at entry must not have received ARVs within 90 days prior to entry and must NOT plan to initiate ARVs within 60 days following study entry Ability to complete all study immunizations and evaluations, in the opinion of the investigator Agrees to use contraception, if necessary Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil count (ANC) of more than 500 per mm3 within the 30 days prior to study entry Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or participants who are emancipated minors must provide informed consent Inclusion Criteria for Step II: Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21 days ago Documented platelet count of more than 50,000 per mm3 and an ANC of more than 500 per mm3 within the 30 days prior to Step II entry If a woman became pregnant after Dose #1, she must be at more than 14 weeks of gestation and have her obstetrician's permission to receive the vaccine Exclusion Criteria for Step I: Pregnancy Known allergy to egg protein (egg or egg product) or other components in the vaccines (these may include, but are not limited to: neomycin and polymyxin) History, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal influenza vaccines that would contraindicate receipt of any influenza vaccine. History of probable or proven pandemic 2009 Influenza A (H1N1) infection prior to study entry Has received any live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to study entry or expects to receive another nonlicensed agent during the course of the study Has an acute illness or a documented temperature greater than or equal to 100.0 degrees Fahrenheit within 24 hours prior to study entry Use of anti-cancer chemotherapy or radiation therapy within the 36 months preceding study entry or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection) Has an active neoplastic disease Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks in the past 6 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. Nasal and topical steroids are allowed. Has received immunoglobulin or other blood products within the 3 months prior to study entry History of Guillain-Barre syndrome in the subject or subject's family, including parents, siblings, half-siblings, and children Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes 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 within the past 6 months Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol Exclusion Criteria for Step II: Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since Dose #1 or expects to receive another nonlicensed agent before the end of the study Use of anti-cancer chemotherapy or radiation therapy since 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 steroids (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks since vaccine Dose #1 or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) since Dose #1 (nasal and topical steroids are allowed) Has received immunoglobulin or other blood products since Dose #1 Any Grade 3 toxicity or adverse event (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 study vaccine Any Grade 4 injection site reactions or fever experienced by a participant, 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 New occurrence or new awareness of Guillain-Barre syndrome in the participant or participant's family (parents, siblings, half-siblings, or children) since Dose #1 New onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes in both legs (all four absent) since Dose #1 Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) since Dose #1 Documented infection with 2009 Influenza A (H1N1) since Dose #1 Refusal of further vaccination by participant, parent, or guardian Development of any new disease that the investigator judges to be clinically significant or clinically significant findings since Dose #1 that, in the investigator's opinion, would compromise the safety of the subject Withdrawal of consent. Consent may be withdrawn at any time and for any reason, without penalty.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Flynn, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Pediatric Infectious Diseases CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
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
Harbor UCLA Medical Ctr. NICHD CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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
Children's National Med. Ctr. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
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
Univ. of Maryland Baltimore NICHD CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
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
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Rutgers - New Jersey Medical School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
01703
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
Nyu Ny Nichd Crs
City
New York
State/Province
New York
ZIP/Postal Code
10016
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
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
19368788
Citation
Gelinck LB, van den Bemt BJ, Marijt WA, van der Bijl AE, Visser LG, Cats HA, Rimmelzwaan GF, Kroon FP. Intradermal influenza vaccination in immunocompromized patients is immunogenic and feasible. Vaccine. 2009 Apr 21;27(18):2469-74. doi: 10.1016/j.vaccine.2009.02.053. Epub 2009 Feb 24.
Results Reference
background
Citation
Flynn P, Nachman S, Spector SA, Cunningham CK, Weinberg A, Pass R, Muresan P, Levy W, Siberry G, Handelsman E for the IMPAACT P1088 and P1089 Teams: Safety and Immunogenicity of 2009 H1N1 Influenza Immunization in HIV-1 Perinatally Infected Children and Youth. Presented at the IDSA conference, October 2010.
Results Reference
result
Citation
Flynn PM, Nachman S, Spector SA, Cunningham CK, Weinberg A, Pass R, Muresan P, Levy W, Petzold E, Heckman B, Siberry G, Handelsman E for the IMPAACT P1088 and P1089 Teams. 2009 Influenza A (H1N1) Immunization in HIV-1 Perinatally Infected Children and Youth. Presented at the Retroviruses Conference, Feb 2010.
Results Reference
result
PubMed Identifier
25785995
Citation
Curtis DJ, Muresan P, Nachman S, Fenton T, Richardson KM, Dominguez T, Flynn PM, Spector SA, Cunningham CK, Bloom A, Weinberg A. Characterization of functional antibody and memory B-cell responses to pH1N1 monovalent vaccine in HIV-infected children and youth. PLoS One. 2015 Mar 18;10(3):e0118567. doi: 10.1371/journal.pone.0118567. eCollection 2015.
Results Reference
derived
PubMed Identifier
22615311
Citation
Flynn PM, Nachman S, Muresan P, Fenton T, Spector SA, Cunningham CK, Pass R, Yogev R, Burchett S, Heckman B, Bloom A, Utech LJ, Anthony P, Petzold E, Levy W, Siberry GK, Ebiasah R, Miller J, Handelsman E, Weinberg A; IMPAACT P1088 Team. Safety and immunogenicity of 2009 pandemic H1N1 influenza vaccination in perinatally HIV-1-infected children, adolescents, and young adults. J Infect Dis. 2012 Aug 1;206(3):421-30. doi: 10.1093/infdis/jis360. Epub 2012 May 21. Erratum In: J Infect Dis. 2012 Dec 15;206(12):1951.
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://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 Virus Vaccine in HIV Infected Children and Youth

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