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AzTrials

HIV InfectionsPhase 2NCT00992017

Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

A Phase 2 study testing Influenza A (H1N1) monovalent vaccine in people with HIV Infections and H1N1 Influenza Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 31 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

Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. Read more about this study

Who is it for?
Ages 18 to 39 years, women only
Conditions the study is for
HIV Infections, H1N1 Influenza Virus
What is being tested?
Influenza A (H1N1) monovalent vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
31 sitesin 2 countries
Study dates
Oct 2009to Nov 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 18 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Confirmed diagnosis of HIV-1 infection
  • Pregnant
  • Between 14 and 35 weeks of gestation
  • Documented platelet count of greater than 50,000 mm3 and an absolute neutrophil count (ANC) of greater than 500 mm3 within 28 days prior to study entry
  • Able to understand and comply with planned study procedures
  • On antiretroviral therapy (ART) as outlined in the treatment guidelines for pregnant HIV-1 infected women. Women must be currently taking ART or should initiate ART either prior to or concomitantly with the first dose of the vaccine.
  • Received the first dose of influenza A (H1N1) 2009 monovalent vaccine
  • Has a documented platelet count of greater than 50,000 mm3 and an ANC of greater than 500 mm3 within the 28 days prior to Step II entry

Who cannot join

  • Has a known allergy to eggs, egg products, neomycin, or polymyxin
  • Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV
  • Participation in a novel H1N1 influenza vaccine study in the past 2 years
  • Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel influenza H1N1 infection or positive influenza diagnostic test since June 2009 (specificity to H1N1 not required) prior to study entry
  • Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry
  • Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study or expects to receive another nonlicensed agent before delivery
Show all 31Show fewer
  • Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry
  • Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
  • Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus [HPV]-related cervical dysplasia, and cervical intraepithelial neoplasia [CIN] Grades 1, 2, or 3)
  • Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months. Nasal and topical steroids are allowed.
  • Received immunoglobulin or other blood products (with exception of Rho D immune globulin) within the 3 months prior to enrollment in this study
  • Current diagnosis of uncontrolled major psychiatric disorder
  • History of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children)
  • Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes (DTRs) 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 (not thought to be related to pregnancy) within the past 6 months
  • 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 protocol. Pregnancy complications such as preterm labor, hypertension and pre-eclampsia are not exclusion criteria for this study.
  • Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since the study vaccine dose #1 or expects to receive another nonlicensed agent before delivery
  • Use of anti-cancer chemotherapy or radiation therapy since study vaccine 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 prednisone or equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) for more than 2 consecutive weeks (or 2 weeks total) since study vaccine dose #1. Nasal and topical steroids are allowed.
  • Received immunoglobulin or other blood products (with exception of Rho D immune globulin) since study vaccine dose #1
  • A new diagnosis of uncontrolled major psychiatric disorder since study vaccine dose #1
  • New occurrence or new awareness of Guillain-Barre syndrome in the subject or subject's family (including parents, siblings, half-siblings, or children) since study vaccine dose #1
  • A new onset of a neurological disorder including (but not limited to) absent ankle and patellar DTRs in both legs (all four absent) since study vaccine dose #1
  • Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities (not thought to be related to pregnancy) since study vaccine dose #1
  • Any Grade 3 toxicity or 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 the study vaccine dose #1
  • Any Grade 4 injection site reactions or fever experienced by a subject, 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
  • Any new clinical findings since the study vaccine dose #1, that, in the investigator's opinion, would compromise the safety of the participant
  • Participant refuses further vaccination. The subject will still be asked to complete safety visits and be followed in the study.
  • Participant withdraws consent. Participants may withdraw their consent for study participation at any time and for any reason, without penalty.

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States29 sites

  • Usc La Nichd Crs

    Alhambra, California, 91803

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045

  • Johns Hopkins Univ. Baltimore NICHD CRS

    Baltimore, Maryland, 21287

  • 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

  • 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

  • Tulane Univ. New Orleans NICHD CRS

    New Orleans, Louisiana, 70112

  • 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, 07103

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania, 19104

  • 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

  • Washington Hosp. Ctr. NICHD CRS

    Washington D.C., District of Columbia, 20010

  • 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 Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women

Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.

Read the detailed description

On June 11, 2009, the World Health Organization declared a pandemic of the new H1N1 influenza virus, after the virus had caused significant fevers and respiratory illnesses in Mexico and the United States. Pregnant women are at an increased risk of complications from influenza. HIV infected people tend to have lower than normal antibody responses to seasonal influenza vaccines. Data suggest that larger than average doses of a vaccine counteract a weak antibody response. Preliminary results from ongoing studies of influenza A (H1N1) 2009 monovalent vaccines indicate that the vaccine may increase immune activation. This study tested the safety and antibody response of high doses of the influenza A (H1N1) 2009 monovalent vaccine in pregnant women infected with HIV.

Participation in this study lasted until 6 months after participants had delivered their babies or up to 52 weeks. Participants received two doses of the H1N1 vaccine at study entry and after 21 days. Each dose consisted of two intramuscular injections (four total injections). On the days of the injections, participants had their babies' heart rates checked before and after vaccination. At these visits, and at follow-up visits on Days 21, 31, and 42, participants completed a review of symptoms, physical and neurological exams, and a blood draw. For 10 days after receiving each dose of the vaccine, participants were asked to keep track of their temperatures and symptoms or reactions in a journal. Participants were contacted on Day 2 and Day 10 after the first dose of vaccine was given and on Day 2 after the second dose of vaccine was given. Some participants also received a phone call after 6 months.

At delivery of each participant's baby, blood was drawn from both the mother and umbilical cord (or from the baby if the cord blood could not be obtained). At 3 and 6 months after delivery, participants came in for follow-up visits involving, for both mother and child, a review of symptoms, brief physical exams, and blood draws (at 6 months only some women had a clinic visit, the rest received a phone call).

Being tested
Influenza A (H1N1) monovalent vaccine
Keywords
Vaccine, Pregnant, Perinatal
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) monovalent vaccineBiological

    Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart

Study groups in NCT00992017
Study groupRoleWhat they receive
H1N1 vaccineExperimentalPregnant women enrolled received two doses of H1N1 vaccine, administered 21 days apart.
Receives: Biological: Influenza A (H1N1) 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. These 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 6 months after delivery

  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 6 months after delivery

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

    Measured: Measured at Day 21

  4. Percent of Pregnant Women With a Hemagglutination 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 at 10 days after second dose of study vaccine

Secondary outcomes (6)

  1. Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery

    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 delivery of the baby, and at 3 months and 6 months after delivery

  2. Percent of Infants With an 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 birth (via cord blood) and at 3 months and 6 months of age

  3. Maternal Geometric Mean Titers (GMT) of Antibodies HAI

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

    Measured: Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery

  4. Infant GMT of Antibodies HAI

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

    Measured: Measured at birth and at 3 and 6 months of age

  5. Maternal Cell-mediated Immunity (CMI) Responses, as 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 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, at 21 days after first dose of vaccine, at 10 days after second dose

  6. Response to Seasonal 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

Timeline

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

  1. First posted8 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2010
  4. Study completionNov 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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00992017
Sponsor's protocol ID
P1086
Other IDs
10835, IMPAACT P1086
Status last verified
Dec 2014
First submitted
7 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

  • Jamieson DJ, Honein MA, Rasmussen SA, Williams JL, Swerdlow DL, Biggerstaff MS, Lindstrom S, Louie JK, Christ CM, Bohm SR, Fonseca VP, Ritger KA, Kuhles DJ, Eggers P, Bruce H, Davidson HA, Lutterloh E, Harris ML, Burke C, Cocoros N, Finelli L, MacFarlane KF, Shu B, Olsen SJ; Novel Influenza A (H1N1) Pregnancy Working Group. H1N1 2009 influenza virus infection during pregnancy in the USA. Lancet. 2009 Aug 8;374(9688):451-8. doi: 10.1016/S0140-6736(09)61304-0. Epub 2009 Jul 28.

    PubMed 19643469

  • S. Nachman, A. Weinberg, P. Muresan, M. Abzug, R. Ebiasah, E. Petzold, B. Heckman, H. Watts, J. Miller and M. Levin Safety of an Inactivated Influenza A (H1N1) 2009 Monovalent Vaccine (H1N1 vaccine) in HIV-1 Infected Pregnant Women, P1086. Presented at the Retroviruses Conference, Feb 2010

  • Weinberg A, Muresan P, Fenton T, Handelsman E, Watts H, Miller J, Heckman B, Bloom A, Ebiasah R, Petzold E, Levy W, Abzug M, Levin M and Nachman S for IMPAACT P1086 Team: Safety and Immunogenicity of Two Doses of Monovalent Pandemic H1N1 (pH1N1) Influenza Vaccine in HIV-Infected Pregnant Women. Presented at the IDSA conference, October 2010.

  • Abzug MJ, Nachman SA, Muresan P, Handelsman E, Watts DH, Fenton T, Heckman B, Petzold E, Weinberg A, Levin MJ; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team. Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women. Clin Infect Dis. 2013 May;56(10):1488-97. doi: 10.1093/cid/cit057. Epub 2013 Feb 1.

    PubMed 23378284

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza A (H1N1) monovalent vaccine in people with HIV Infections and H1N1 Influenza Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 31 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 8 inclusion and 31 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 31 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 13 Mar 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 6 months after delivery). 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 NCT00992017, 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 5 Nov 2021.

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