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Phase I STEBVax in Healthy Adults

NCT00974935 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-06-19

No results posted yet for this study

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.

Conditions

  • Toxic Shock Syndrome Staphylococcal

Interventions

DRUG

Aluminum hydroxide

Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.

BIOLOGICAL

STEBVax vaccine

Single dose of recombinant staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01, 0.1, 0.5, 2.5, 10 or 20 mcg intramuscular and 2 doses of 20 mcg intramuscular 21 days apart. STEBVax vaccine will be administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the non-dominant arm; subjects in the 2 dose cohort will have the vaccine administered in the alternate arm.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974935 on ClinicalTrials.gov