Phase I STEBVax in Healthy Adults
Completed · Phase 1
Conditions studied: Toxic Shock Syndrome Staphylococcal
In brief
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.
Key facts
- Study ID
- NCT00974935
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 29
- Starts
- 2011-02-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-06-19
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ability to provide written informed consent.
- Age 18 - 40 years, inclusive.
- Good "general health" as determined by vital signs (heart rate <100 bpm; blood pressure systolic > 90 mm Hg and less than or equal to 140 mm Hg; diastolic > 50 mm Hg and less than or equal to 90 mm Hg; oral temperature <100.4 degrees Fahrenheit), medical history, and a physical examination within 45 days before administration of Recombinant Staphylococcal Enterotoxin B Vaccine (STEBVax). Blood pressure outside this range may be repeated once on another occasion.
- Expressed interest and availability to fulfill the study requirements
- Agrees not to become pregnant from the time of study enrollment until at least 90 days after the last administration of STEBVax; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), condoms with spermicidal agents, or must have a vasectomized partner, or must be sexually abstinent. A woman is eligible if she is monogamous with a vasectomized male
- Agrees not to participate in another clinical trial at any time during the study period.
- Agrees to remain in the Baltimore-Washington metropolitan area for 7 days after vaccination.
You may not qualify if…
- History of any of the following medical illnesses:
- Toxic shock syndrome
- Asthma requiring daily prescription medication
- Psychiatric disorder requiring hospitalization
- Anaphylaxis/hypersensitivity reactions to glycine, or alum (vaccine components)
- Coagulopathy
- Kidney disease
- Diabetes
- Cancer
- Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
- Vascular disease (peripheral vascular disease, coronary artery disease, stroke)
- Arthritis
- Autoimmune disease (e.g., lupus erythematosis, rheumatoid arthritis)
- Unconsciousness (other than a single brief "concussion")
- Seizures (other than febrile seizures as a child <5 years old)
- Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
- Any current illness requiring regular medication therapy other than vitamins or birth control
- Any clinically significant abnormality including but not limited to:
- Murmur (other than a functional murmur)
- Focal neurological
- Hepatosplenomegaly
- Lymphadenopathy
- Jaundice
- Lab abnormality, as listed below. Toxicity grading scale provided in Appendix B, Normal ranges provided in Appendix C. Laboratories with abnormalities possibly transient in nature may be repeated one time.
- Hemoglobin, White blood cell count, Neutrophil count, or Platelet count outside the normal range
Where it is running
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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