Phase I STEBVax in Healthy Adults

NCT00974935 | Completed Phase 1

• 2 other identifiers: 07-0009HHSN272200800006C
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxic Shock Syndrome Staphylococcal

Keywords

Staphylococcal enterotoxin B, vaccine, Staphylococcus aureus, toxic shock syndrome

Outcome Measures

Primary Outcomes (1)

• Data describing safety of Staphylococcal Enterotoxin B Vaccine (STEBVax) (clinical observations and clinical laboratory measurements) given in one of several escalating doses.

  Through Day 56.

Secondary Outcomes (1)

• The rate and titer of seroconversion with serum immunoglobulin G (IgG) anti-Staphylococcus aureus enterotoxin B antibodies by enzyme-linked immunosorbent assay (ELISA).

  Day 56 and, for the two-dose group, day 77 (56 days after the second dose).

Study Arms (7)

Cohort 1

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 2

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.1 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 3

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.5 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 4

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 2.5 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 5

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 10 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 6

EXPERIMENTAL

Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 20 mcg intramuscular.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Cohort 7

EXPERIMENTAL

Two doses of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 20 mcg intramuscular 21 days apart.

Drug: Aluminum hydroxide; Biological: STEBVax vaccine

Interventions

Aluminum hydroxide DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

STEBVax vaccine BIOLOGICAL

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Baltimore, Maryland, 21201-1509, United States

Location

Related Publications (1)

• Chen WH, Pasetti MF, Adhikari RP, Baughman H, Douglas R, El-Khorazaty J, Greenberg N, Holtsberg FW, Liao GC, Reymann MK, Wang X, Warfield KL, Aman MJ. Safety and Immunogenicity of a Parenterally Administered, Structure-Based Rationally Modified Recombinant Staphylococcal Enterotoxin B Protein Vaccine, STEBVax. Clin Vaccine Immunol. 2016 Dec 5;23(12):918-925. doi: 10.1128/CVI.00399-16. Print 2016 Dec.

  PMID: 27707765 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Shock, Septic

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: February 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 19, 2015

Record last verified: 2014-09

Locations

US (1)