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

Respiratory Tract Diseases Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382408
• Other study ID #: DR-ADV-301
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2006
• Last updated: April 24, 2012
• Start date: September 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4041
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Tract Diseases

Intervention

Biological:
• DR-5001
1 tablet x 1

Other:
• Placebo
1 tablet x 1

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Fort Jackson	South Carolina
United States	Duramed Investigational Site	Great Lakes	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Throat Culture Positive for Wild Type-4 Adenovirus (ADV) Infection	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.	At Week 4	No
Primary	Number of Participants With Throat Culture Positive for Wild Type-7 Adenovirus (ADV) Infection	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.	At Week 4	No
Secondary	Number of ADV Type-4 Booster Participants With Increase in Titer	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.	Baseline to end of Week 8	No
Secondary	Number of ADV Type-7 Booster Participants With Increase in Titer	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.	Baseline to end of Week 8	No