A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00382408
First received: September 27, 2006
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.


Condition Intervention Phase
Respiratory Tract Diseases
Biological: DR-5001
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Number of Participants With Throat Culture Positive for Wild Type-4 Adenovirus (ADV) Infection [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    For the oral Type-4 vaccine, the attack rate of the febrile Type-4 ADV-associated ARD cases observed among subjects in the vaccine group and placebo group from the day of study medication administration (Day 0) to the final study visit (Day 56) will be calculated.

  • Number of Participants With Throat Culture Positive for Wild Type-7 Adenovirus (ADV) Infection [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    For the oral Type-7 vaccine, seroconversion rates observed at Week 4 (Day 26) for the oral Type-7 ADV vaccine and placebo groups will be calculated. For the purpose of inference, evaluation of reduction in ADV-4 febrile ARD attack rate will be tested first. If the criterion for success is met, then evaluation of ADV-7 seroconversion will proceed.


Secondary Outcome Measures:
  • Number of ADV Type-4 Booster Participants With Increase in Titer [ Time Frame: Baseline to end of Week 8 ] [ Designated as safety issue: No ]
    ADV-4 booster effect: is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-4 titer is ≥1:4.

  • Number of ADV Type-7 Booster Participants With Increase in Titer [ Time Frame: Baseline to end of Week 8 ] [ Designated as safety issue: No ]
    ADV-7 booster effect: is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-7 titer is ≥1:4.


Enrollment: 4041
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: DR-5001
1 tablet x 1
Placebo Comparator: 2 Other: Placebo
1 tablet x 1

Detailed Description:

The study will be conducted at two sites and will include a minimum of 4 visits. The overall study duration for participants will be approximately 8 weeks. Study participants will undergo acute respiratory disease evaluation that will include a throat swab and a blood draw. Each participant will also be contacted in six months for follow-up information.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Military recruit in training
  • Male or female; if female, must be of non-childbearing potential or with a documented negative pregnancy test </= 72 hours prior to study medication administration and agree not to become pregnant

Exclusion Criteria:

  • Female nursing an infant or planning on nursing during the study
  • Immunosuppressed for any reason, including past (within last 6 months) or current treatment with immunosuppressive therapy
  • Known allergy to any component of the vaccines and/or placebo tablets
  • Immunocompromised sexual partner or immunocompromised individuals in home
  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: NCT00382408

Locations
United States, Illinois
Duramed Investigational Site
Great Lakes, Illinois, United States, 60088
United States, South Carolina
Duramed Investigational Site
Fort Jackson, South Carolina, United States, 29207
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00382408     History of Changes
Other Study ID Numbers: DR-ADV-301
Study First Received: September 27, 2006
Results First Received: July 28, 2011
Last Updated: April 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Acute respiratory disease prevention
Adenovirus

Additional relevant MeSH terms:
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014