Can a blood product fix smallpox vaccine side effects?
NCT ID NCT01374984
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether VIGIV, a blood product with antibodies, helps people who have serious reactions to the smallpox vaccine. It will track 100 patients to see if their skin lesions improve and if their antibody levels change. The goal is to confirm that VIGIV works as a treatment for these rare but severe complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vaccinia Immune Globulin Intravenous (Human) (VIGIV)
- What this could lead to
- If successful, this could confirm that VIGIV effectively treats serious complications from smallpox vaccination, providing a reliable treatment option.
- What could go wrong
- This is an observational post-marketing study, not a controlled trial, so results may be less definitive. The small sample size (100) and lack of a comparison group limit how strongly we can conclude effectiveness.
Why investors are watching
Emergent BioSolutions is running a post-marketing study of its smallpox treatment VIGIV, testing whether the drug resolves complications from smallpox vaccination in 100 patients. For a small company, this readout matters because VIGIV is a commercial product, and a clear benefit could support its continued use and sales. The result is consequential because it directly affects the drug's reputation and the company's revenue base.
If it works: A positive result could strengthen confidence in VIGIV as a reliable treatment for vaccine complications, potentially supporting steady demand from government and healthcare buyers. That could reinforce Emergent's position in the smallpox preparedness market.
If it fails: If the study shows weak or unclear benefit, doctors and buyers may question VIGIV's value, which could hurt sales. Trials often fail to show clear results, and a negative outcome would put pressure on a small company that depends on this product.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2007
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions. * Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard. * Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor. Exclusion Criteria: None.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.