Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT00974935
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2009-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I STEBVax in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase I Study of the Safety and Immunogenicity of Recombinant Staphylococcal Enterotoxin B Vaccine (STEBVax) in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to test the safety of a new vaccine, STEBVax, which may lead to a useful treatment for toxic shock syndrome. The second purpose is to determine whether STEBVax causes the body to produce antibodies (proteins that fight infection) to help the body resist disease. Researchers expect STEBVax shots will cause the development of antibodies in the blood. Study participants will include up to 42 healthy adults, ages 18-40, from the University of Maryland Baltimore community. Participants will be assigned to one of 7 vaccine dose groups. Assignment to dosage groups will depend on when individuals are enrolled in the study. Study procedures will include blood sampling, urine collection, and physical examinations. Subjects will maintain a memory aid documenting daily oral temperatures and possible vaccine side effects. Participants will be involved in study related procedures for up to 201 days.
Detailed Description:
This study is a Phase I study of the safety and immunogenicity of recombinant Staphylococcal Enterotoxin B vaccine (STEBVax) in healthy adults. STEBVax is a recombinant mutated form of staphylococcal enterotoxin B (SEB) containing three point mutations that disrupt the interaction of the toxin with human major histocompatibility complex (MHC) class II receptors and render the protein non-toxic while retaining most of the immunogenicity. The primary intended result of this program is the development of a hyperimmune serum for treatment of toxic shock syndrome (TSS) originating from nosocomial, environmental or potential bioterrorist events. An additional long-term goal is the development of a multivalent vaccine and immunotherapeutic for treating or preventing diseases caused by Staphylococcus (S.) aureus. The long-range goal is to develop a vaccine that will protect against a broad range of staphylococcal superantigens. The primary objective is to evaluate and assess the safety of parenterally administered STEBVax vaccine in healthy adult subjects over a range of doses from 0.01 to 20 mcg by intramuscular injection. The secondary objectives are to determine the immunogenicity of STEBVax vaccine over a range of doses as determined by the rate and titer of seroconversion with serum anti-S. aureus enterotoxin B IgG antibodies measured by enzyme-linked-immunosorbent serologic assay (ELISA). Participants will include 28 healthy adult subjects from the University of Maryland Baltimore community. Subjects will receive a dose of STEBVax in Alhydrogel adjuvant at one of the following doses: 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg or 2 doses of 20 mcg given 21 days apart. STEBVax will be administered as a single 0.5 mL intramuscular injection. Subjects will be followed for safety, reactogenicity, and immune response after vaccination. Subjects will be observed in the clinic for at least 8 hours after vaccination and remain in the Baltimore-Washington metropolitan area for 7 days after vaccination.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN272200800006C | None | None | View |