HIV InfectionsPhase 1/2NCT00091702
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
A Phase 1/2 study testing Cold-adapted live attenuated influenza vaccine (FluMist) and Inactivated influenza vaccine (IAIV) in people with HIV Infections and Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 61 sites in 2 countries.
Trial summary
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- HIV Infections, Influenza
- What is being tested?
- Cold-adapted live attenuated influenza vaccine (FluMist) and Inactivated influenza vaccine (IAIV)
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 61 sitesin 2 countries
- Study dates
- Start not givento Jan 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIV infected
- Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated
- Meet certain CD4 cell count and CD4% requirements
- Viral load of less than 60,000 copies/ml within 60 days prior to study start
- Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years
- Written informed consent of parent or legal guardian
- Availability of parent or legal guardian to be contacted by phone
Who cannot join
- Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing
- Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization
- History of hypersensitivity to any component of IAIV or FluMist
- History of Guillain-Barre syndrome
- Receipt of any inactivated vaccine within 14 days prior to the study vaccination
- Receipt of any live vaccine within 30 days prior to the study vaccination
Show all 18Show fewer
- Plans to receive any vaccine within the 30 days following the vaccination
- Receipt of any additional influenza vaccine for the duration of the study
- Prophylactic use of drugs with anti-influenza activity
- Moderate chronic pulmonary disease, obstructive or restrictive
- Cardiopulmonary disease affecting normal childhood activity
- Medically-diagnosed wheezing, bronchodilator use, or steroid use within the past 42 days
- Medical illness associated with suppression of T-cell immunity
- Pregnancy, breast-feeding, or unwillingness to use acceptable methods of contraception for 3 months following vaccination
- Severely immunosuppressed household member
- Receipt of any blood products within 3 months prior to vaccination or expected receipt during the study, including the 6-month follow-up period
- Significant fever or illness within 72 hours prior to vaccination
- Any other condition that would interfere with the study
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States59 sites
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203-2098
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, 27599-7220
Chicago Children's CRS
Chicago, Illinois, 60614
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois
Columbus Regional HealthCare System, The Med. Ctr.
Columbus, Georgia, 31901
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
DUMC Ped. CRS
Durham, North Carolina, 27705
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316
Children's Diagnostic & Treatment Ctr. of South Florida
Fort Lauderdale, Florida
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610-0296
Connecticut Children's Med. Ctr.
Hartford, Connecticut
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Lawrence Family Health Ctr., Essex St. Clinic
Lawrence, Massachusetts, 01841-2884
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801
Usc La Nichd Crs
Los Angeles, California, 90033
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California
Lowell Community Health Ctr.
Lowell, Massachusetts, 01854
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105-2794
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33136
Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
Mobile, Alabama
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112-2699
Nyu Ny Nichd Crs
New York, New York, 10016
Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases
New York, New York, 10029
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
Columbia IMPAACT CRS
New York, New York
NJ Med. School CRS
Newark, New Jersey
Children's Hosp. of the King's Daughters, Infectious Disease
Norfolk, Virginia, 23507
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 94609-1809
Children's Hosp. of Orange County
Orange, California, 92868
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 19104-4318
Phoenix Children's Hosp.
Phoenix, Arizona, 85006
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 92103
UCSF Pediatric AIDS CRS
San Francisco, California, 94143-0105
Seattle Children's Hospital CRS
Seattle, Washington, 98105-0371
UW School of Medicine - CHRMC
Seattle, Washington, 98105
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.
St Louis, Missouri, 63110
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794-8111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
USF - Tampa NICHD CRS
Tampa, Florida, 33620
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461
Jacobi Med. Ctr.
The Bronx, New York, 10461
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90509
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20010
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts
Puerto Rico2 sites
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00936-5067
San Juan City Hosp. PR NICHD CRS
San Juan
About this study
Official title: A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.
Read the detailed description
Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respiratory illnesses and bacterial infections. HIV infected children may have an increased risk for developing influenza-related bacterial complications, and influenza infections among this population may lead to more rapid disease progression. The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately, FluMist is associated with viral shedding, a period of time when the influenza virus used to produce the vaccine may be transmitted to other people. This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination.
Participants in this study will be randomly assigned to one of two arms. Arm A participants will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A physical exam will be performed at the initial study visit; blood will be collected at study start and at each visit thereafter. Phone calls will be made to participants throughout the study. All participants will have a final study visit after 6 months.
- Conditions
- HIV Infections, Influenza
- Being tested
- Cold-adapted live attenuated influenza vaccine (FluMist), Inactivated influenza vaccine (IAIV)
- Keywords
- FluMist, Influenza Vaccine, Adolescent, Treatment Experienced
- Medical subject headings
- HIV Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-adapted live attenuated influenza vaccine (FluMist)Biological
Inactivated influenza vaccine (IAIV)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2004 (estimated)
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Myron J. Levin, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091702
- Sponsor's protocol ID
- P1057
- Other IDs
- 10612, PACTG P1057
- Status last verified
- Oct 2021
- First submitted
- 16 Sep 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Gunthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31. doi: 10.1086/315260.
PubMed 10669335Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998 May 14;338(20):1405-12. doi: 10.1056/NEJM199805143382002.
PubMed 9580647King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, Newman F, Belshe RB, Kovacs A, Deville JG, Jelonek M; HIV Influenza Study Group. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J. 2001 Dec;20(12):1124-31. doi: 10.1097/00006454-200112000-00006.
PubMed 11740317King JC Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, Lambert JS, Belshe RB. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000 Feb;181(2):725-8. doi: 10.1086/315246.
PubMed 10669363Weinberg A, Song LY, Walker R, Allende M, Fenton T, Patterson-Bartlett J, Nachman S, Kemble G, Yi TT, Defechereux P, Wara D, Read JS, Levin M; IMPAACT P1057 Team. Anti-influenza serum and mucosal antibody responses after administration of live attenuated or inactivated influenza vaccines to HIV-infected children. J Acquir Immune Defic Syndr. 2010 Oct;55(2):189-96. doi: 10.1097/QAI.0b013e3181e46308.
PubMed 20581690
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
- ClinicalTrials.gov ID
- NCT00091702
- Acronym / sponsor ID
- P1057
- Conditions
- HIV Infections, Influenza
- Keywords
- FluMist, Influenza Vaccine, Adolescent, Treatment Experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Jan 2006 (actual)
- First posted
- 20 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.
Detailed description
Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respiratory illnesses and bacterial infections. HIV infected children may have an increased risk for developing influenza-related bacterial complications, and influenza infections among this population may lead to more rapid disease progression. The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately, FluMist is associated with viral shedding, a period of time when the influenza virus used to produce the vaccine may be transmitted to other people. This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination.
Participants in this study will be randomly assigned to one of two arms. Arm A participants will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A physical exam will be performed at the initial study visit; blood will be collected at study start and at each visit thereafter. Phone calls will be made to participants throughout the study. All participants will have a final study visit after 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- HIV infected
- Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated
- Meet certain CD4 cell count and CD4% requirements
- Viral load of less than 60,000 copies/ml within 60 days prior to study start
- Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years
Key exclusion criteria (18 listed)
- Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing
- Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization
- History of hypersensitivity to any component of IAIV or FluMist
- History of Guillain-Barre syndrome
- Receipt of any inactivated vaccine within 14 days prior to the study vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-adapted live attenuated influenza vaccine (FluMist) | Biological | – |
| Inactivated influenza vaccine (IAIV) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 10669335Gunthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31. doi: 10.1086/315260.
- Background: PubMed 9580647Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998 May 14;338(20):1405-12. doi: 10.1056/NEJM199805143382002.
- Background: PubMed 11740317King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, Newman F, Belshe RB, Kovacs A, Deville JG, Jelonek M; HIV Influenza Study Group. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J. 2001 Dec;20(12):1124-31. doi: 10.1097/00006454-200112000-00006.
- Background: PubMed 10669363King JC Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, Lambert JS, Belshe RB. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000 Feb;181(2):725-8. doi: 10.1086/315246.
- Results publication: PubMed 20581690Weinberg A, Song LY, Walker R, Allende M, Fenton T, Patterson-Bartlett J, Nachman S, Kemble G, Yi TT, Defechereux P, Wara D, Read JS, Levin M; IMPAACT P1057 Team. Anti-influenza serum and mucosal antibody responses after administration of live attenuated or inactivated influenza vaccines to HIV-infected children. J Acquir Immune Defic Syndr. 2010 Oct;55(2):189-96. doi: 10.1097/QAI.0b013e3181e46308.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron J. Levin, MD study chair
University of Colorado, Denver
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cold-adapted live attenuated influenza vaccine (FluMist) and Inactivated influenza vaccine (IAIV) in people with HIV Infections and Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 61 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091702, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.