VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection|
- Resolution of vaccinia infection complications [ Time Frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable) ] [ Designated as safety issue: No ]
- Vaccinia antibody levels [ Time Frame: Day 5 post VIGIV-infusion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
A plasma sample for the determination of anti-vaccinia antibody level collected 5 days after VIGIV administration and 5 days after VIGIV re-dosing as well (if applicable). Samples collected Day 5 ±3 days will still provide valuable information for assessing anti-vaccinia antibody levels in these subjects post-VIGIV administration. While plasma samples are preferred, serum samples will also be accepted if available. Failure to obtain a Day 5 sample does not preclude retrospective enrollment into the VA-005 study to provide observational data only.
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Subjects treated with VIGIV.
Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:
VIGIV is licensed in US, by the FDA, for the treatment of complications of smallpox vaccinations and is available to eligible patients regardless of participation in this study.
Other Name: Vaccinia Immune Globulin Intravenous (Human)
This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the first 100 consented patients treated with VIGIV.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374984
|Study Chair:||Jason S Richardson, PhD||Cangene Corporation (doing business as Emergent BioSolutions)|