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Otitis MediaPhase 1/2NCT00617682

Maternal Immunization To Prevent Infant Otitis Media

A Phase 1/2 study testing PNCRM9 in people with Otitis Media, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.

Completed

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

Official record
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Trial summary

The main objective of this study is to evaluate whether immunization with 9-valent pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six months of life. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Otitis Media
What is being tested?
PNCRM9
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
2 sitesUnited States
Study dates
Oct 2000to Dec 2004
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Maternal inclusion criteria:
  • Pregnant, at least 18 yrs of age and healthy based on medical history.
  • Plans to continue HealthPartners insurance coverage until infant is 13 mos old; mother and child will receive care in staff model clinic participating in the study, and obstetric care will be provided by a HP obstetrician/CNM with delivery at affiliated hospital.
  • Plans to reside in Twin Cities metro area until infant is 13 mos old.
  • Has a residence phone and a back-up phone contact.
  • Provides informed consent.
  • Infant inclusion criteria:
  • Infants born to enrolled women.

Who cannot join

  • Maternal exclusion criteria:
  • Known hypersensitivity to any of the vaccine components or to latex.
  • Prior vaccination with any S. pneumoniae vaccine.
  • Recent (w/in 2 mos) vaccination with diphtheria or tetanus-diphtheria toxoid vaccines. Administration of influenza, or any other vaccine, or RhoGAM in the 2 wks prior to administration of the study product.
  • Known history of life-threatening pneumococcal infection.
  • Known impairment of immunologic function or history of immunodeficiency.
Show all 23Show fewer
  • Previous child with a major congenital anomaly or fetal malformation.
  • Known to be carrying more than one fetus.
  • Any medical condition or history that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
  • History of preterm birth or fetal death.
  • Known history of chronic hypertension, severe pre-eclampsia in a previous pregnancy, current pre-eclampsia or any type of diabetes mellitus.
  • Known anatomical defects of the cervix or uterus.
  • Known history of teratogenic drug use or illegal substance abuse during current pregnancy, not including tobacco or alcohol use.
  • Women who have tested positive (based on medical record information) for HIV or hepatitis B infection.
  • Any contraindication specified in the vaccine manufacturer's CIB.
  • History of febrile illness (temp 100.0 degrees F or over) during the 72 hrs prior to vaccine administration.
  • History of significant mental illness (e.g. schizophrenia, psychoses, major depression).
  • Infant exclusion criteria:
  • Hypersensitivity to any component of the vaccine, including diphtheria toxoid.
  • Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
  • Latex sensitivity.
  • Known impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection, or other causes that may reduce antibody response to active immunization.
  • Vaccination may be delayed because of a current or recent febrile illness depending largely on the severity of the symptoms and their etiology. Although a severe or even a moderate febrile illness is sufficient reason to postpone vaccinations, minor illnesses, such as a mild upper respiratory infection with or without low-grade fever, are not generally contraindications.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • HealthPartners Research Foundation

    Bloomington, Minnesota, 55440

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

The main objective of this study is to evaluate whether immunization with 9-valent pneumococcal conjugate vaccine (PNCRM9) during the third trimester of pregnancy interferes with active antibody production in offspring immunized with PNCRM7 (Prevnar) in the first six months of life.

Read the detailed description

There were 24.5 million physician visits for otitis media (OM) in 1990 with estimated treatment and indirect costs of $5 billion. Because of its major public health impact and the troubling increase in antibiotic resistant organisms, vaccine strategies to prevent OM are being tested. We previously proposed an efficacy study to determine if immunization with pneumococcal vaccine during pregnancy protects offspring against early infant OM, which is an important predictor for recurrent and chronic OM. Recent data from an efficacy trial in California demonstrated that infants immunized with 7-valent pneumococcal conjugate vaccine (PNCRM7) at 2, 4, 6 and 12 - 15 months were protected against invasive pneumococcal disease after 7 months of age. Since licensure of this vaccine, questions have been raised about whether maternal immunization with a pneumococcal vaccine during pregnancy suppresses active antibody production in offspring who are immunized with 7-valent pneumococcal conjugate vaccine (PNCRM7). The main objective of this study is to investigate that question. We will also evaluate vaccine safety, immunogenicity, and fetal antibody transfer among women who receive 9-valent pneumococcal conjugate vaccine (PNCRM9) at 30 - 35 weeks of pregnancy, determine persistence of maternal and infant antibody 13 months after birth, evaluate opsonic activity of maternal and infant antibody, and determine the relationship between breast milk and serum antibody in lactating women.

Conditions
Otitis Media
Being tested
PNCRM9, Placebo comparator
Keywords
Maternal immunization, Pneumococcal conjugate vaccine, Otitis media
Medical subject headings
Otitis Media

What participants receive

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

  • PNCRM9Biological

    0.5 mL IM at 30-35 wks gestation

  • Placebo comparatorBiological

    Sucrose cake (NaCl and sucrose) in aluminum phosphate adjuvant diluent at 0.5 mg per 0.5 mL dose IM at 30-35 wks gestation

Study groups in NCT00617682
Study groupRoleWhat they receive
Group 1Active comparatorGroup 1 (experimental)
Receives: Biological: PNCRM9
Group 2Placebo comparatorGroup 2 (placebo comparator)
Receives: Biological: Placebo comparator

What is being measured

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

  1. Determine if offspring of women immunized with PNCRM9 or control during the third trimester have equivalent anticapsular polysaccharide (PS) IgG antibody responses to PNCRM7 measured 1 mo after the 3rd injection given at 6 mos of age.

    Measured: In infants at 7 months of age; In women at 1-7 days post-immunization

Secondary outcomes (1)

  1. Determine if offspring of these women have equivalent antibody responses to PNCRM7 at 13 mos. Sera are analyzed for anti-PS IgG, opsonic activity, IgG1 & IgG2 subclasses (14,6B,19F,23F), & antibodies against Hib-PRP & diphtheria toxoid.

    Measured: In infants at 13 months of age.

Timeline

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

  1. First posted18 Feb 2008 (estimated)
  2. Study startOct 2000
  3. Primary completionDec 2004
  4. Study completionDec 2004

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617682
Sponsor's protocol ID
R01DC005974-03
Status last verified
Feb 2008
First submitted
14 Feb 2008
Last updated
18 Feb 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Le CT, Grambsch PM, Giebink GS. Quality control and the identification of vaccine responders using ELISA-derived antibody data. Stat Med. 2003 Sep 30;22(18):2935-42. doi: 10.1002/sim.1530.

    PubMed 12953289

  • Daly KA, Toth JA, Giebink GS. Pneumococcal conjugate vaccines as maternal and infant immunogens: challenges of maternal recruitment. Vaccine. 2003 Jul 28;21(24):3473-8. doi: 10.1016/s0264-410x(03)00354-2.

    PubMed 12850363

  • Daly KA, Scott Giebink G, Lindgren BR, Knox J, Haggerty BJ, Nordin J, Goetz S, Ferrieri P. Maternal immunization with pneumococcal 9-valent conjugate vaccine and early infant otitis media. Vaccine. 2014 Dec 5;32(51):6948-6955. doi: 10.1016/j.vaccine.2014.10.060. Epub 2014 Oct 30.

    PubMed 25444821

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PNCRM9 in people with Otitis Media, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 2 sites in United States.

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 23 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 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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.

What does the primary outcome measure?

Determine if offspring of women immunized with PNCRM9 or control during the third trimester have equivalent anticapsular polysaccharide (PS) IgG antibody responses to PNCRM7 measured 1 mo after the 3rd injection given at 6 mos of age. (time frame: In infants at 7 months of age; In women at 1-7 days post-immunization). 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 NCT00617682, which also lists 3 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 18 Feb 2008.

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