Maternal Immunization To Prevent Infant Otitis Media

NCT00617682 | Completed Phase 1 DMC

• 1 other identifier: R01DC005974-03
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Otitis Media

Keywords

Maternal immunization; Pneumococcal conjugate vaccine; Otitis media

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (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.

  In infants at 13 months of age.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 (experimental)

Biological: PNCRM9

Group 2

PLACEBO COMPARATOR

Group 2 (placebo comparator)

Biological: Placebo comparator

Interventions

PNCRM9 BIOLOGICAL

0.5 mL IM at 30-35 wks gestation

Group 1

Placebo comparator BIOLOGICAL

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Infants born to enrolled women.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (2)

HealthPartners Research Foundation

Bloomington, Minnesota, 55440, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

• 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.

  PMID: 12953289 BACKGROUND

• 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.

  PMID: 12850363 BACKGROUND

• 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.

  PMID: 25444821 DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Patricia Ferrieri

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 18, 2008
• Study Start: October 1, 2000
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 18, 2008

Record last verified: 2008-02

Locations

US (2)