Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
NCT ID: NCT00992836
Last Updated: 2021-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2009-10-31
2010-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Influenza A (H1N1) 2009 monovalent vaccine
All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.
Influenza A (H1N1) 2009 monovalent vaccine
Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
Interventions
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Influenza A (H1N1) 2009 monovalent vaccine
Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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.
4 Years
25 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Pat Flynn, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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UAB Pediatric Infectious Diseases CRS
Birmingham, Alabama, United States
Usc La Nichd Crs
Alhambra, California, United States
University of California, UC San Diego CRS
La Jolla, California, United States
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Univ. of California San Francisco NICHD CRS
San Francisco, California, United States
Harbor UCLA Medical Ctr. NICHD CRS
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Pediatric Perinatal HIV Clinical Trials Unit CRS
Miami, Florida, United States
USF - Tampa NICHD CRS
Tampa, Florida, United States
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States
Univ. of Maryland Baltimore NICHD CRS
Baltimore, Maryland, United States
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, United States
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, United States
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States
Nyu Ny Nichd Crs
New York, New York, United States
Metropolitan Hosp. NICHD CRS
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Bronx-Lebanon CRS
The Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States
Texas Children's Hospital CRS
Houston, Texas, United States
Seattle Children's Research Institute CRS
Seattle, Washington, United States
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Click here for information on the IMPAACT group and for the package insert on the H1N1 vaccine.
Click here for the table used for grading toxicities: DAIDS Grading Severity of AEs, V1.0, Dec04.
Other Identifiers
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10840
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMPAACT P1088
Identifier Type: -
Identifier Source: secondary_id
P1088
Identifier Type: -
Identifier Source: org_study_id