Complication of Smallpox VaccinationNCT01374984
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
An observational study of Complication of Smallpox Vaccination, run by Emergent BioSolutions.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication of Smallpox Vaccination
- What is being tested?
- VIGIV
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.
Who may be able to join
- 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.
Who cannot join
- None.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Complication of Smallpox Vaccination
- Being tested
- VIGIV
- Keywords
- smallpox, vaccination, complications
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIGIVBiological
Also called Vaccinia Immune Globulin Intravenous (Human)
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with VIGIV. | 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). Receives: Biological: VIGIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of vaccinia infection complications
Change in number, size, type, and percentage of body affected by lesions following treatment.
Measured: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
Secondary outcomes (1)
Vaccinia antibody levels
Measurement of serum concentration of anti-vaccinia antibodies.
Measured: Day 5 post VIGIV-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startAug 2007
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Smallpox VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- David Cassie, MSc, Study chair, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374984
- Sponsor's protocol ID
- VA-005
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2011
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
- ClinicalTrials.gov ID
- NCT01374984
- Acronym / sponsor ID
- VA-005
- Conditions
- Complication of Smallpox Vaccination
- Keywords
- smallpox, vaccination, complications
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2007 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with VIGIV. | – | Biological: VIGIVSubjects 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIGIVAlso: Vaccinia Immune Globulin Intravenous (Human)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. | Biological | Subjects treated with VIGIV. |
Primary outcome
Resolution of vaccinia infection complications
Time frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
Change in number, size, type, and percentage of body affected by lesions following treatment.
1 secondary outcome
Vaccinia antibody levels
Time frame: Day 5 post VIGIV-infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] United States Prescribing Information, 1/2010.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Cassie, MSc study chair
Emergent BioSolutions
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Smallpox Vaccination, run by Emergent BioSolutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of vaccinia infection complications (time frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.