A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers
|ClinicalTrials.gov Identifier: NCT01466738|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : February 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: HRV-16 (100 TCID50) Biological: HRV-16 (1000 TCID50)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Characterization of a Human Rhinovirus Type 16 Challenge Pool Following Intranasal Administration to Healthy Adult Subjects|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|Experimental: HRV-16 (100 TCID50)||
Biological: HRV-16 (100 TCID50)
Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
|Experimental: HRV-16 (1000 TCID50)||
Biological: HRV-16 (1000 TCID50)
Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
- Clinical symptoms to HRV-16 [ Time Frame: 6 days ]Clinical symptoms to HRV-16 will be assessed using the Cold Symptom Assessment form, which is a 5-point scale of the severity of cold symptoms.
- Serological Response [ Time Frame: Approximately 4 weeks ]Blood samples will be evaluated for serum-neutralizing antibody titer levels to HRV-16.
- The number of adverse events [ Time Frame: Approximately 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466738
|United States, Virginia|
|Charlottesville, Virginia, United States|
|Study Director:||Centocor Ortho Biotech Services, L.L.C. Clinical Trial||Centocor Ortho Biotech Services, L.L.C.|