Respiratory Tract DiseasesPhase 3NCT00382408

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

A Phase 3 study testing DR-5001 in people with Respiratory Tract Diseases, run by Duramed Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 17 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Tract Diseases
What is being tested?: DR-5001
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,040 participants
Where: 2 sitesUnited States
Study dates: Sep 2006to Dec 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Duramed Investigational Site
Fort Jackson, South Carolina, 29207
Duramed Investigational Site
Great Lakes, Illinois, 60088

Other trials in United States

About this study

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

Read the 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.

Conditions: Respiratory Tract Diseases
Being tested: DR-5001, Placebo
Keywords: Acute respiratory disease prevention, Adenovirus
Medical subject headings: Respiratory Tract Diseases, Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DR-5001Biological
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.
PlaceboOther
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.

Study groups in NCT00382408
Study group	Role	What they receive
Vaccine	Experimental	Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). Receives: 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). Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4

Secondary outcomes (6)

Percentage of Participants Showing ADV-4 Seroconversion at 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.
Measured: Week 4
Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
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.
Measured: Day 0 - Day 56
Percentage of Participants Showing ADV Type-4 Booster at 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.
Measured: Baseline, Week 4
Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
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.
Measured: Day 0 - Day 56
Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
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.
Measured: Day 0 - Day 56
Percentage of Participants Showing ADV Type-7 Booster at 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.
Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Dec 2007

First posted29 Sep 2006 (estimated)
Study startSep 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4,040 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00382408
Sponsor's protocol ID: DR-ADV-301
Status last verified: Mar 2017
First submitted: 27 Sep 2006
Last updated: 10 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001
ClinicalTrials.gov ID: NCT00382408
Acronym / sponsor ID: DR-ADV-301
Conditions: Respiratory Tract Diseases
Keywords: Acute respiratory disease prevention, Adenovirus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,040 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 29 Sep 2006 (estimated)
Results: Posted 25 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vaccine	Experimental	Biological: DR-5001Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
Placebo	Placebo comparator	Other: PlaceboParticipants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DR-5001All 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.	Biological	Vaccine
PlaceboAll 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.	Other	Placebo

Primary outcome

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.
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.
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.
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.

6 secondary outcomes

Percentage of Participants Showing ADV-4 Seroconversion at Week 4
Time frame: Week 4
Number of Participants With Wild Type-4 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
Time frame: Day 0 - Day 56
Percentage of Participants Showing ADV Type-4 Booster at Week 4
Time frame: Baseline, Week 4
Number of Participants With Wild Type-7 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
Time frame: Day 0 - Day 56
Number of Participants With Wild Type-7 Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort
Time frame: Day 0 - Day 56
Percentage of Participants Showing ADV Type-7 Booster at Week 4
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 25 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaccine	3,031	2,887
Placebo	1,009	955

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

Time frame: Day 0 - Day 56. Number. Unit: participants

Measure	Vaccine n = 3031	Placebo n = 1009
Value	1	48

Vaccine vs Placebo: vaccine efficacy (VE): 99.31 (95% CI 96.02 to 99.88)

Population analysed: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.

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

Time frame: Day 0 - Day 56. Number. Unit: participants

Measure	Vaccine n = 2855	Placebo n = 945
Value	1	47

Population analysed: The per-protocol (PP) cohort included all participants who met the eligibility criteria set forth in the protocol, did not have any significant violations or deviations from the protocol, and completed the final study visit (Day 56). Subjects who vomited within 24 hours after taking the study medication were excluded from the PP cohort.

Primary outcome: 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. Number. Unit: participants

Measure	Vaccine n = 3031	Placebo n = 1009
Value	0	44

Population analysed: The intent-to-treat (ITT) cohort included all participants randomized and treated in the study.

Primary outcome: Percentage of Participants Showing ADV-7 Seroconversion at Week 4

Time frame: Week 4. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vaccine n = 1120	Placebo n = 359
Value	93.8 (92.4 to 95.2)	5.3 (3.0 to 7.6)

Population analysed: Type-7 ADV Seroconversion Cohort: Included those subjects who had a negative Type-7 ADV serum neutralizing antibody status at baseline (\<1:4) and at least one titer value for ADV-7 at the subsequent visits following vaccination.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 (vaccination day) - Day 56. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	12 of 1,009 (1.2%)	916 of 1,009 (90.8%)	Not reported
Vaccine	35 of 3,031 (1.2%)	2,673 of 3,031 (88.2%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duramed Protocol Chair study chair

Duramed Research, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DR-5001 in people with Respiratory Tract Diseases, run by Duramed Research at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Wild Type-4 Febrile Adenovirus (ADV) Acute Respiratory Disease (ARD) -- ITT Cohort (time frame: Day 0 - Day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00382408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.