Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00006630
Other study ID # AVEG 801
Secondary ID 11551
Status Withdrawn
Phase Phase 1
First received
Last updated

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Description:

VIG (Human) is a component of plasma from persons vaccinated with vaccinia vaccine. It is the only product available for the treatment of vaccinia and other orthopox infections. The only lot currently available was released as a licensed product in 1995 but is being treated as an investigational new drug because of slight discoloration in the solution. This study makes existing stocks of VIG available as a short-term solution for the lack of a licensed immune globulin to treat vaccinal infections. Before receiving injections and 3 and 6 months after injections, patients are tested for HIV, hepatitis B, and hepatitis C with pre- and post-test counseling. Referrals for appropriate medical care are provided. Participants have multiple injections (depending on body weight) of VIG at 1 or 2 clinic visits. Following administration of VIG, participants are observed for 1/2 hour at the clinic. Participants return to the clinic for as many as 10 visits to monitor for any adverse reactions and signs and symptoms of vaccinia infections. On Days 7, 84, and 168 participants return to the clinic for evaluations and have blood drawn to check for the response to the VIG injections.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vaccinia Immune Globulin (Human)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1