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

NCT00382408 | Completed Phase 3 Results DMC

• 1 other identifier: DR-ADV-301
• Study Type: interventional
• Target: 4,040
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Respiratory Tract Diseases

Keywords

Acute respiratory disease prevention; Adenovirus

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort

  For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.

  Day 0 - Day 56

• Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- PP Cohort

  For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the per protocol cohort.

  Day 0 - Day 56

• Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort --- Day 11-56

  For the oral Type-4 vaccine, the primary outcome is the number of cases of ADV-4 febrile acute respiratory disease (ARD), defined as a subject with one or more clinical signs and symptoms of ARD and an oral temperature ≥ 100.5°F (38.06°C) and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort; further, this outcome omitted ARD cases from Day 0-Day 10 because the protective effect of the vaccine was unlikely to take place during that time period.

  Day 11 - Day 56

• Percentage of Participants Showing ADV-7 Seroconversion at Week 4

  ADV-7 seroconversion was defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) after study medication that represented at least a fourfold increase in titer from baseline (visit 0) in a subject whose baseline Type-7 titer was \<1:4.

  Week 4

Secondary Outcomes (6)

• Percentage of Participants Showing ADV-4 Seroconversion at Week 4

  Week 4

• Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort

  Day 0 - Day 56

• Percentage of Participants Showing ADV Type-4 Booster at Week 4

  Baseline, Week 4

• Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort

  Day 0 - Day 56

• Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort

  Day 0 - Day 56

Study Arms (2)

Vaccine

EXPERIMENTAL

Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).

Biological: DR-5001

Placebo

PLACEBO COMPARATOR

Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).

Other: Placebo

Interventions

DR-5001 BIOLOGICAL

All randomized subjects received a single tablet of both Type-4 and Type-7 ADV vaccines on Day 0. Both vaccine tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.

Vaccine

Placebo OTHER

All randomized subjects received a single tablet each of the placebos matching Type-4 and Type-7 ADV vaccines on Day 0. Both placebo tablets were administered orally, kept in the mouth as briefly as possible and swallowed whole with water. Chewing the tablets was not permitted.

Placebo

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duramed Research: lead

Study Sites (2)

Duramed Investigational Site

Great Lakes, Illinois, 60088, United States

Location

Duramed Investigational Site

Fort Jackson, South Carolina, 29207, United States

Location

MeSH Terms

Conditions

Respiratory Tract Diseases; Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

In the past 6 years, Type-7 ADV has only rarely been recovered from recruits with ARD (Russell 2007). Therefore, it may not be possible to directly measure the protective effect of the vaccine against Type-7 ADV in the proposed study.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

info.era-clinical@teva.de

215-591-3000

Study Officials

• Duramed Protocol Chair

  Duramed Research, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 29, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 10, 2017
• Results First Posted: May 25, 2012

Record last verified: 2017-03

Locations

US (2)