Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children

NCT00345670 | Completed Phase 1 DMC

• 1 other identifier: MI-CP130
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.

Conditions

Healthy

Keywords

Lower respiratory tract illness; RSV and PIV3 infection

Outcome Measures

Primary Outcomes (4)

• To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children

  Day 28

• Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing

  Day 28 post final vaccination

• Adverse events (AEs) from administration of study vaccine through 28 post-dosing

  Day 28 post final vaccination

• Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing

  Day 180

Secondary Outcomes (2)

• To describe the immunogenicity and viral shedding of MEDI-534

  Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.

• The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples

  Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.

Study Arms (3)

1

EXPERIMENTAL

MEDI-534

Biological: MEDI-534

2

EXPERIMENTAL

MEDI-534

Biological: MEDI-534

3

EXPERIMENTAL

MEDI-534

Biological: MEDI-534

Interventions

MEDI-534 BIOLOGICAL

10:4 TCID50 of MEDI-534 intranasal spray Study Day 0

1

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female aged 1 through 9 years old
• In general good health
• Seropositive for RSV (enzyme-linked immunosorbent assay \[ELISA\] titer \> 12 U/ml) and PIV3 (hemagglutination-inhibition \[HAI\] titer \> 1:8)
• Subject's parent/legal representative available by telephone
• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
• Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
• Ability to complete the follow-up period of 6 months following dosing as required by the protocol

You may not qualify if:

• Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
• Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
• Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
• Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
• Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
• Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
• Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
• Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
• History of Guillain-Barré syndrome
• Known or suspected immunodeficiency, including HIV
• Known or suspected acute or chronic hepatitis infection
• Living at home or attending day care with children less than or equal to 24 months of age
• Contact with pregnant caregiver
• Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing
• History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (12)

Edinger Medical Group

Fountain Valley, California, 92708, United States

Location

Heart of America Research

Shawnee, Kansas, 66216, United States

Location

Heart of America Research

Topeka, Kansas, 66614, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Cincinnati Children's Hospital Medical Center, Division of Infectious Disease

Crestview Hills, Kentucky, 41017, United States

Location

University of Maryland Pediatric Ambulatory Center

Baltimore, Maryland, 21201, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Regional Clinical Research, Inc.

Binghamton, New York, 13901, United States

Location

Children's Hospital at Montefiore; Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Pediatric Associates of Mt. Carmel, Inc.

Cincinnati, Ohio, 45245, United States

Location

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

University Physicians Internal Medicine

Huntington, West Virginia, 25701-3655, United States

Location

Related Publications (1)

• Gomez M, Mufson MA, Dubovsky F, Knightly C, Zeng W, Losonsky G. Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children. Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.

  PMID: 19483659 DERIVED

Study Officials

• Margarita M Gomez, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2007
• Last Updated: September 3, 2008

Record last verified: 2008-09

Locations

US (12)