Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Duramed Protocol Chair | Duramed Research, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duramed Investigational Site | Great Lakes | Illinois | 60088 | United States | ||
| Duramed Investigational Site |
Participants were randomized to either the vaccine group or the matching placebo group in a 3:1 ratio.
The study was conducted in subjects undergoing military basic training.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). |
| BG001 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | Posted | Number | participants | Day 0 - Day 56 |
|
Day 0 (vaccination day) - Day 56
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BASEDOW'S DISEASE | Endocrine disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 215-591-3000 | info.era-clinical@teva.de |
Not provided
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | Baseline, Week 4 |
| Fort Jackson |
| South Carolina |
| 29207 |
| United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Lost to Follow-up |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Type-4 Titer | Negative = titer value <1:4 Positive = titer value >=1:4 | Number | participants |
|
| Type-7 Titer | Negative = titer value <1:4 Positive = titer value >=1:4 | Number | participants |
|
| 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). |
|
|
|
| Primary | 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. | 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. | Posted | Number | participants | Day 0 - Day 56 |
|
|
|
| Primary | 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. | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | Posted | Number | participants | Day 11 - Day 56 |
|
|
|
| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
| Secondary | 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. | Type-4 ADV Seroconversion Cohort: Included those subjects who had a negative Type-4 ADV serum neutralizing antibody status at baseline (<1:4) and at least one titer value for ADV-4 at the subsequent visits following vaccination. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
| Secondary | 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. | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | Posted | Number | participants | Day 0 - Day 56 |
|
|
|
|
| Secondary | 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. | Type-4 ADV Booster Cohort included subjects who had a positive Type-4 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-4 at the subsequent visits following study medication administration. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 4 |
|
|
|
| Secondary | 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. | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | Posted | Number | participants | Day 0 - Day 56 |
|
|
|
| Secondary | 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. | The intent-to-treat (ITT) cohort included all participants randomized and treated in the study. | Posted | Number | participants | Day 0 - Day 56 |
|
|
|
| Secondary | 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. | Type-7 ADV Booster Cohort included subjects who had a positive Type-7 ADV serum neutralizing antibody status at baseline (≥ 1:4) and at least one titer value for ADV Type-7 at the subsequent visits following study medication administration. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 4 |
|
|
|
| 12 |
| 1,009 |
| 916 |
| 1,009 |
| EG001 | Vaccine | Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0). | 35 | 3,031 | 2,673 | 3,031 |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| HERNIA | General disorders | MedDRA | Systematic Assessment |
|
| FOOD ALLERGY | Immune system disorders | MedDRA | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| BRONCHITIS ACUTE | Infections and infestations | MedDRA | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| LIGAMENT INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| STRUCK BY LIGHTNING | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| ADJUSTMENT DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| ADJUSTMENT DISORDER WITH ANXIETY | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| ADJUSTMENT DISORDER WITH DEPRESSED MOOD | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| CYCLOTHYMIC DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| PERSONALITY DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| STRESS | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.