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HIV InfectionsPhase 2NCT00992836

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

A Phase 2 study testing Influenza A (H1N1) 2009 monovalent vaccine in people with HIV Infections and H1N1 Influenza Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 to 25 years
Conditions the study is for
HIV Infections, H1N1 Influenza Virus
What is being tested?
Influenza A (H1N1) 2009 monovalent vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
37 sitesin 2 countries
Study dates
Oct 2009to Aug 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 4 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States35 sites

  • Usc La Nichd Crs

    Alhambra, California, 91803

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045

  • Univ. of Maryland Baltimore NICHD CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins Univ. Baltimore NICHD CRS

    Baltimore, Maryland, 21287

  • UAB Pediatric Infectious Diseases CRS

    Birmingham, Alabama, 35233

  • Children's Hosp. of Boston NICHD CRS

    Boston, Massachusetts, 02115

  • Boston Medical Center Ped. HIV Program NICHD CRS

    Boston, Massachusetts, 02118

  • Rush Univ. Cook County Hosp. Chicago NICHD CRS

    Chicago, Illinois, 60612

  • Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS

    Chicago, Illinois, 60614-3393

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • South Florida CDTC Ft Lauderdale NICHD CRS

    Fort Lauderdale, Florida, 33316

  • Texas Children's Hospital CRS

    Houston, Texas, 77030-2399

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida, 32209

  • University of California, UC San Diego CRS

    La Jolla, California, 92093-0672

  • Miller Children's Hosp. Long Beach CA NICHD CRS

    Long Beach, California, 90806

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California, 90095-1752

  • St. Jude Children's Research Hospital CRS

    Memphis, Tennessee, 38105-3678

  • Pediatric Perinatal HIV Clinical Trials Unit CRS

    Miami, Florida, 33136

  • Nyu Ny Nichd Crs

    New York, New York, 10016

  • Metropolitan Hosp. NICHD CRS

    New York, New York, 10029

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Rutgers - New Jersey Medical School CRS

    Newark, New Jersey, 01703

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 19104

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York, 14642

  • Univ. of California San Francisco NICHD CRS

    San Francisco, California, 94143

  • Seattle Children's Research Institute CRS

    Seattle, Washington, 98101

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794-8111

  • USF - Tampa NICHD CRS

    Tampa, Florida, 33606

  • Bronx-Lebanon CRS

    The Bronx, New York, 10457

  • Jacobi Med. Ctr. Bronx NICHD CRS

    The Bronx, New York, 10461

  • Harbor UCLA Medical Ctr. NICHD CRS

    Torrance, California, 90502

  • Children's National Med. Ctr. Washington DC NICHD CRS

    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, 01605

Other trials in United States

Puerto Rico2 sites

  • University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

    San Juan, 00935

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Influenza A (H1N1) 2009 monovalent vaccine
Keywords
Influenza A Virus, H1N1 Subtype, Vaccine, Children, Adolescents, HIV-Infected, Perinatal HIV Infection, Treatment experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza A (H1N1) 2009 monovalent vaccineBiological

    Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections

Study groups in NCT00992836
Study groupRoleWhat they receive
Influenza A (H1N1) 2009 monovalent vaccineExperimentalAll participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.
Receives: Biological: Influenza A (H1N1) 2009 monovalent vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Measured up to 7 months after vaccination

  2. 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.

    Measured: Measured up to 7 months after vaccination

  3. Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose

    Measured: Measured at Day 21

  4. 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.

    Measured: Measured at 21 days after first dose and 10 days after second dose

Secondary outcomes (5)

  1. Percent of Participants With an HAI Titer >=40 at Long-term Follow-up

    Measured: Measured at 6 months after second dose

  2. Geometric Mean Antibody Titers (GMT) HAI

    Presents the value of the geometric mean titer at each time point.

    Measured: Measured after first and second doses and 6 months after second dose

  3. 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.

    Measured: Measured at entry, 21 days after first dose, and 10 days after second dose

  4. 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.

    Measured: Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose

  5. 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.

    Measured: Measured at entry, 21 days after first dose, and 10 days after second dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00992836
Sponsor's protocol ID
P1088
Other IDs
10840, IMPAACT P1088
Status last verified
Dec 2014
First submitted
8 Oct 2009
Last updated
5 Nov 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19423869

  • 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.

    PubMed 19368788

  • 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.

    PubMed 25785995

  • 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.

    PubMed 22615311

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza A (H1N1) 2009 monovalent vaccine in people with HIV Infections and H1N1 Influenza Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 37 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 11 inclusion and 30 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 5 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 37 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 9 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Number of Participants Who Had at Least One Adverse Event (AE) (time frame: Measured up to 7 months after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00992836, which also lists 6 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 5 Nov 2021.

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