An observational study in Complication of Smallpox Vaccination, sponsored by Emergent BioSolutions. Enrolling by invitation. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Emergent BioSolutions · Observational
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.
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.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
Browse Smallpox studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:
Exclusion Criteria:
None.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions: * Eczema vaccinatum. * Progressive vaccinia. * Severe generalized vaccinia. * Vaccinia infections in individuals who have skin conditions. * Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).
Biological: VIGIV
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.
Also known as: Vaccinia Immune Globulin Intravenous (Human)
Resolution of vaccinia infection complications
Change in number, size, type, and percentage of body affected by lesions following treatment.
Time frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
Vaccinia antibody levels
Measurement of serum concentration of anti-vaccinia antibodies.
Time frame: Day 5 post VIGIV-infusion
No study locations are listed for this record.
Plan to share: Undecided
Started Aug 2007 (actual). Primary completion is estimated for Aug 2027, 240 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.