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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,040
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.
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.
Duramed Investigational Site
Great Lakes, Illinois, United States
Duramed Investigational Site
Fort Jackson, South Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 4