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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Tract Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vaccine

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

Group Type EXPERIMENTAL

DR-5001

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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DR-5001

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.

Intervention Type BIOLOGICAL

Placebo

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes