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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00345670
First received: June 27, 2006
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: MEDI-534
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy RSV and PIV3 Seropositive 1-9 Year-Old Children

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing [ Time Frame: Day 28 post final vaccination ] [ Designated as safety issue: Yes ]
  • Adverse events (AEs) from administration of study vaccine through 28 post-dosing [ Time Frame: Day 28 post final vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the immunogenicity and viral shedding of MEDI-534 [ Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: 1
MEDI-534
Biological: MEDI-534
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
Experimental: 2
MEDI-534
Biological: MEDI-534
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
Experimental: 3
MEDI-534
Biological: MEDI-534
10:6 TCID50 of MEDI-534; intranasal spray

Detailed Description:

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 RSV and PIV3 at screening. MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion. A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril. The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts. Randomization will be stratified by site. This study will enroll during the RSV off season at multiple sites in the United States and Chile.

  Eligibility

Ages Eligible for Study:   1 Year to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Previous medical history, or evidence, of chronic illness may compromise the safety of the subject
  • At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study
  • History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
  • Passive primary household smoking
  • Family member or household contact who is an employee of the research center with the conduct of the study
  • Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345670

Locations
United States, California
Edinger Medical Group
Fountain Valley, California, United States, 92708
United States, Kansas
Heart of America Research
Shawnee, Kansas, United States, 66216
Heart of America Research
Topeka, Kansas, United States, 66614
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
Cincinnati Children's Hospital Medical Center, Division of Infectious Disease
Crestview Hills, Kentucky, United States, 41017
United States, Maryland
University of Maryland Pediatric Ambulatory Center
Baltimore, Maryland, United States, 21201
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, New York
Regional Clinical Research, Inc.
Binghamton, New York, United States, 13901
Children's Hospital at Montefiore; Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Ohio
Pediatric Associates of Mt. Carmel, Inc.
Cincinnati, Ohio, United States, 45245
United States, Pennsylvania
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States, 15241
United States, West Virginia
University Physicians Internal Medicine
Huntington, West Virginia, United States, 25701-3655
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Margarita M Gomez, M.D. MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margarita M Gomez, M.D., MedImmune LLC
ClinicalTrials.gov Identifier: NCT00345670     History of Changes
Other Study ID Numbers: MI-CP130
Study First Received: June 27, 2006
Last Updated: September 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Lower respiratory tract illness
RSV and PIV3 infection

Additional relevant MeSH terms:
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2014