HIV-1 InfectionNCT01484522
Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth
An observational study of HIV-1 Infection and H1N1, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 17 sites in 2 countries.
Trial summary
The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body. Read more about this study
- Who is it for?
- Ages 6 months to 25 years
- Conditions the study is for
- HIV-1 Infection, H1N1, Influenza
- What is being tested?
- FluMist, Fluvirin and Fluzone
- Type of treatment
- Vaccines
- How many people
- 149 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Oct 2009to Sep 2010
- Phase
- Observational
- 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 6 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: HIV-1 perinatally infected children and youth 6 months to 25 years of age. For inclusion into the study, if perinatal acquisition of HIV infection cannot be confirmed based on the child's medical record, it is acceptable to enroll the child if the investigator's assessment is that the most likely route of infection was perinatal.
Who may be able to join
- Children and youth 6 months to <25 years of age at study entry.
- HIV infection, defined as positive test results obtained from 2 different samples. Tests may include two of the same type OR two different types of tests listed below, as long as there are positive test results obtained from 2 different samples:
- HIV-1 antibody (ELISA + WB), obtained at age >18 months
- HIV-1 culture, any age
- HIV-1 DNA PCR, any age
- HIV-1 RNA PCR >10,000 copies/mL, any age
Show all 13Show fewer
- Neutralizable HIV-1 p24 antigen obtained >28 days of age
- In the opinion of the investigator, the route of HIV-1 transmission is perinatally acquired.
- Parent or legal guardian, youth of legal age, or subjects who are emancipated minors, who are willing and able to provide signed informed consent.
- Planned receipt of one of the following FDA licensed Influenza A (H1N1) 2009 Monovalent Vaccines within 24 hours following study entry:
- Group A: Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune FluMist®)
- Group B: Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Fluvirin®)
- Group C: Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur Fluzone®) *OR has received one of the above vaccines within 4 hours prior to study entry.
Who cannot join
- Has a history of probable or proven pandemic 2009 H1N1 Influenza A virus infection prior to study entry.
- Has received seasonal FluMist vaccine within 2 weeks prior to study entry.
- Has received any 2009 H1N1 vaccines prior to the day of entry.
- Has received any immunoglobulin or blood products within 3 months prior to study entry.
- Has 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 study.
- 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 (more than or equal to 2 mg/kg per day or more than or equal to 20 mg total dose) for more than 2 weeks in the past 6 months, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, 80045
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, 35294
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, 02115
Chicago Children's CRS (4001)
Chicago, Illinois, 60614
Wayne State University/Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
USC/Los Angeles County Medical Center NICHD CRS
Los Angeles, California, 90033
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, 38105-2794
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, 33136
New York University NY (5012)
New York, New York, 10016
NJ Med School CRS (2802)
Newark, New Jersey, 07103
The Children's Hospital of Philadelphia (6701)
Philadelphia, Pennsylvania, 19104
University of California San Francisco NICHD CRS (5091)
San Francisco, California, 94143
SUNY Stony Brook (5040)
Stony Brook, New York, 11794-8111
University of South Florida Tampa (5018)
Tampa, Florida, 33620
Jacobi Medical Center Bronx (5013)
The Bronx, New York, 10461
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01605
Puerto Rico1 site
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, 00936-5067
About this study
Official title: A Laboratory Study to Assess the Immunogenicity of Three Licensed Influenza A (H1N1) 2009 Monovalent Vaccines in HIV-1 Perinatally Infected Children and Youth
The purpose of this research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body.
HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
Read the detailed description
HIV-infected children typically respond poorer to vaccines as compared to normal children. The FDA has currently approved several Influenza A 2009 monovalent vaccines to be used in children and adults. However, little data is available in perinatally infected youth. Therefore, knowledge of the immunogenicity of several of the licensed Influenza A 2009 monovalent vaccines in HIV-infected children and youth is critically important to address the health care needs of this vulnerable population. Efforts are currently underway to evaluate Influenza A 2009 monovalent vaccines in healthy children as well as other populations. This study will assess the immune response following receipt of three Influenza A monovalent vaccines in HIV-1 infected children and youth. Protection of HIV-1 infected children and youth from 2009 H1N1 Influenza A will require knowledge of immunogenicity of these new products in this population. The 2009 (H1N1) Influenza A virus is likely to infect a significant proportion of HIV-1 infected children and youth. Immunogenicity of licensed and commercially available Influenza A 2009 monovalent vaccines must be established in HIV-1 infected children in order to assure that this population is protected. Lack of a protective immune response would support the need for additional measures to protect this high risk population.
- Conditions
- HIV-1 Infection, H1N1, Influenza, Flu
- Being tested
- FluMist, Fluvirin, Fluzone
- Keywords
- Influenza, Perinatal, immunogenicity, Monovalent vaccine, Children, Youth, H1N1, Adolescent, Flu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMistBiological
Administered at the manufacture's recommended dose
FluvirinBiological
Vaccine administered at the manufacturer's recommended dose.
FluzoneBiological
Vaccine administered at manufacturer's recommended dose
| Study group | Role | What they receive |
|---|---|---|
| Group A | Influenza A 2009 Monovalent vaccine Receives: Biological: FluMist | |
| Group B | Influenza A 2009 monovalent vaccine Receives: Biological: Fluvirin | |
| Group C | Influenza A 2009 monovalent vaccine Receives: Biological: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years.
Measured: 8 months
The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age.
Measured: 8 months
Secondary outcomes (6)
The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age.
Measured: 8 months
Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine.
Measured: 8 months
Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV).
Measured: 8 months
Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV).
Measured: 8 months
Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV).
Measured: 8 months
Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Patricia M. Flynn, M.D., Study chair, St. Jude Childrens Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484522
- Sponsor's protocol ID
- IMPAACT P1089
- Other IDs
- U01AI068632
- Status last verified
- Nov 2011
- First submitted
- 29 Sep 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Study to Assess the Immunogenicity of Three Licensed Influenza A (H1N1) 2009 Monovalent Vaccines in HIV-1 Perinatally Infected Children and Youth
- ClinicalTrials.gov ID
- NCT01484522
- Acronym / sponsor ID
- IMPAACT P1089
- Conditions
- HIV-1 Infection, H1N1, Influenza, Flu
- Keywords
- Influenza, Perinatal, immunogenicity, Monovalent vaccine, Children, Youth, H1N1, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Dec 2011 (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 research study is to evaluate the immune response to the H1N1 influenza or "flu" vaccine. The "immune response" is how your body recognizes and defends itself against bacteria, viruses, and substances that may be harmful to the body.
HIV-1 infected children typically respond more poorly to vaccines compared to uninfected, healthy children and so this study hopes to learn whether or not the body will successfully produce enough antibodies (proteins that fight infection) that will prevent or fight the H1N1 flu virus. There is no information yet on the safety or immune response to this vaccine in children infected with HIV.
Detailed description
HIV-infected children typically respond poorer to vaccines as compared to normal children. The FDA has currently approved several Influenza A 2009 monovalent vaccines to be used in children and adults. However, little data is available in perinatally infected youth. Therefore, knowledge of the immunogenicity of several of the licensed Influenza A 2009 monovalent vaccines in HIV-infected children and youth is critically important to address the health care needs of this vulnerable population. Efforts are currently underway to evaluate Influenza A 2009 monovalent vaccines in healthy children as well as other populations. This study will assess the immune response following receipt of three Influenza A monovalent vaccines in HIV-1 infected children and youth. Protection of HIV-1 infected children and youth from 2009 H1N1 Influenza A will require knowledge of immunogenicity of these new products in this population. The 2009 (H1N1) Influenza A virus is likely to infect a significant proportion of HIV-1 infected children and youth. Immunogenicity of licensed and commercially available Influenza A 2009 monovalent vaccines must be established in HIV-1 infected children in order to assure that this population is protected. Lack of a protective immune response would support the need for additional measures to protect this high risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Biological: FluMistInfluenza A 2009 Monovalent vaccine |
| Group B | – | Biological: FluvirinInfluenza A 2009 monovalent vaccine |
| Group C | – | Biological: FluzoneInfluenza A 2009 monovalent vaccine |
Who may qualify
- Ages
- 6 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-1 perinatally infected children and youth 6 months to 25 years of age. For inclusion into the study, if perinatal acquisition of HIV infection cannot be confirmed based on the child's medical record, it is acceptable to enroll the child if the investigator's assessment is that the most likely route of infection was perinatal.
Key inclusion criteria (13 listed)
- Children and youth 6 months to <25 years of age at study entry.
- HIV infection, defined as positive test results obtained from 2 different samples. Tests may include two of the same type OR two different types of tests listed below, as long as there are positive test results obtained from 2 different samples:
- In the opinion of the investigator, the route of HIV-1 transmission is perinatally acquired.
- Parent or legal guardian, youth of legal age, or subjects who are emancipated minors, who are willing and able to provide signed informed consent.
- Planned receipt of one of the following FDA licensed Influenza A (H1N1) 2009 Monovalent Vaccines within 24 hours following study entry:
Key exclusion criteria (8 listed)
- Has a history of probable or proven pandemic 2009 H1N1 Influenza A virus infection prior to study entry.
- Has received seasonal FluMist vaccine within 2 weeks prior to study entry.
- Has received any 2009 H1N1 vaccines prior to the day of entry.
- Has received any immunoglobulin or blood products within 3 months prior to study entry.
- Has 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 study.
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 |
|---|---|---|
| FluMistAdministered at the manufacture's recommended dose | Biological | Group A |
| FluvirinVaccine administered at the manufacturer's recommended dose. | Biological | Group B |
| FluzoneVaccine administered at manufacturer's recommended dose | Biological | Group C |
Primary outcome
The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years.
Time frame: 8 months
The short term immune response following second immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine in perinatally HIV-1 infected children > 6 months to < 10 years of age.
Time frame: 8 months
6 secondary outcomes
The immune response following first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine in children aged > 6 months to < 10 years of age.
Time frame: 8 months
Persistence of antibody responses 7 months after receipt of the first immunization with a licensed Influenza A (H1N1) 2009 monovalent vaccine.
Time frame: 8 months
Immune responses with CD4+ cell count and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with CD4 percent and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with ARV use and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
Immune responses with plasma HIV-1 RNA concentration and timing of seasonal trivalent influenza vaccine (TIV).
Time frame: 8 months
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 2 Dec 2011.
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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.
Patricia M. Flynn, M.D. study chair
St. Jude Childrens Research Hospital
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Infection and H1N1, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 17 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 13 inclusion and 8 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
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.
What does the primary outcome measure?
The short term immune response following immunization with a licensed Influenza A (H1N1) 2009 Monovalent Vaccine administered as a single dose in perinatally HIV-1 infected children and youth aged >10 to <25 years. (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2011.