WithdrawnPhase 1

Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection

Plain-language summary

The purpose of this study is to follow responses to treatment with vaccinia immune globulin (VIG) for safety and clinical benefit \[during HIV vaccine research\]. VIG is purified from human blood and used to treat serious infections of the vaccinia (smallpox vaccine) virus or similar viruses. It is the only treatment available for those viruses. The only available supply of VIG has developed a discoloration over time and therefore is considered an investigational new drug by the FDA. This study will allow it to be used for intramuscular injection in a controlled setting for people who may need it \[during HIV vaccine research\].

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Participants may be eligible for this study if they: * Sign a consent form including consent for pre/post HIV counseling. If under 18 years or unable to sign a consent form, the next of kin or a legal guardian must sign. * Experience complications from prior administration of vaccinia virus vaccinations or accidental exposure to vaccinia or similar viruses. * Have a pregnancy test. Exclusion Criteria Participants will not be eligible for this study if they: * Have eye complications. Note: * Caution should be noted if participants are allergic to thimerosal (a preservative in the study drug). Precautions can be taken if participants experience a reaction during VIG administration. * Women who are pregnant will be counseled about risks.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00006630

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.