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NCT Number: NCT00382408

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

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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Key information

Conditions

Respiratory Tract Diseases Adenoviridae Infections DNA Virus Infections Infections Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Great Lakes, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Day 0 - Day 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.

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

    Time frame: Day 0 - Day 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 per protocol cohort.

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

    Time frame: Day 11 - Day 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.

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

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants Showing ADV-4 Seroconversion at Week 4

    Time frame: Week 4

    ADV-4 seroconversion was defined as the development of ADV Type-4 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-4 titer was <1:4.

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

    Time frame: Day 0 - Day 56

    For the oral Type-4 vaccine, the number of cases of ADV-4 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-4 infection. This outcome used the intent-to-treat cohort.

  3. Percentage of Participants Showing ADV Type-4 Booster at Week 4

    Time frame: Baseline, Week 4

    ADV-4 booster effect is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-4 titer is ≥1:4.

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

    Time frame: Day 0 - Day 56

    For the oral Type-7 vaccine, a secondary outcome is the number of cases of ADV-7 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-7 infection. This outcome used the intent-to-treat cohort.

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

    Time frame: Day 0 - Day 56

    For the oral Type-7 vaccine, the number of cases of ADV-7 acute respiratory disease (ARD) regardless of whether the participant was febrile or not. Therefore includes participants with one or more clinical signs and symptoms of ARD and throat culture positive for wild ADV Type-7 infection. This outcome used the intent-to-treat cohort.

  6. Percentage of Participants Showing ADV Type-7 Booster at Week 4

    Time frame: Baseline, Week 4

    ADV-7 booster effect is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represented at least a fourfold increase in titer from baseline (Visit 0) in a participant whose baseline Type-7 titer is ≥1:4.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 29, 2006
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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