Toxic Shock Syndrome StaphylococcalPhase 1NCT00974935
Phase I STEBVax in Healthy Adults
A Phase 1 study testing Aluminum hydroxide and STEBVax vaccine in people with Toxic Shock Syndrome Staphylococcal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxic Shock Syndrome Staphylococcal
- What is being tested?
- Aluminum hydroxide and STEBVax vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 46Show fewer
- 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
- PT, PTT above the normal range
- Sodium, or potassium outside the normal range
- Creatinine above normal range
- Glucose outside the normal range (65 to <110 mg/dL is acceptable if non-fasting test)
- AST, ALT, alkaline phosphatase, total bilirubin of grade 1 or greater on the toxicity grading scale
- Urinalysis with proteinuria or hematuria
- Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen (Subjects will be informed if their results are positive for hepatitis C, HIV antibody or hepatitis B surface antigen and will be referred to a primary care provider for follow up of these abnormal laboratory tests.)
- Have a positive urine drug screen.
- For women, positive serum pregnancy test within 45 days and urine pregnancy test within 24 hours of administering STEBVax at days 0 and for the highest dose group who receive two doses of vaccine, on day 21.
- Nursing mother
- Temperature > 38.0 degrees C (100.4 degrees F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days before administration of STEBVax
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Failure to pass written examination (70 percent correct answers required to pass) on the first attempt. (The exam is administered to assess and document comprehension of the material presented which covers all aspects of the study including the purpose, procedures, risks, benefits and pertinent microbiology).
- Receipt of an experimental agent (vaccine, drug, device, etc.) within 28 days before administration of STEBVax or expects to receive an experimental agent during the study period.
- Receipt of any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before vaccination in this study or expects to receive a licensed vaccine before vaccination in this study.
- Known sensitivity to any ingredient in STEBVax (recombinant protein, glycine, sodium chloride, alum)
- Prosthetic joint
- Receipt of immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
About this study
Official title: Phase I Study of the Safety and Immunogenicity of Recombinant Staphylococcal Enterotoxin B Vaccine (STEBVax) in Healthy Adults
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.
Read the 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.
- Conditions
- Toxic Shock Syndrome Staphylococcal
- Being tested
- Aluminum hydroxide, STEBVax vaccine
- Keywords
- Staphylococcal enterotoxin B, vaccine, Staphylococcus aureus, toxic shock syndrome
- Medical subject headings
- Staphylococcal Infections, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum hydroxideDrug
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.
STEBVax vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01 mcg intramuscular. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Aluminum hydroxide; Biological: STEBVax vaccine |
| Cohort 5 | Experimental | Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 10 mcg intramuscular. Receives: Drug: Aluminum hydroxide; Biological: STEBVax vaccine |
| Cohort 6 | Experimental | Single dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 20 mcg intramuscular. Receives: 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. Receives: Drug: Aluminum hydroxide; Biological: STEBVax vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data describing safety of Staphylococcal Enterotoxin B Vaccine (STEBVax) (clinical observations and clinical laboratory measurements) given in one of several escalating doses.
Measured: 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).
Measured: Day 56 and, for the two-dose group, day 77 (56 days after the second dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toxic Shock Syndrome StaphylococcalStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974935
- Sponsor's protocol ID
- 07-0009
- Other IDs
- HHSN272200800006C
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2009
- Last updated
- 19 Jun 2015
- Results posted
- No
Publications
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.
PubMed 27707765
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Immunogenicity of Recombinant Staphylococcal Enterotoxin B Vaccine (STEBVax) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00974935
- Acronym / sponsor ID
- 07-0009
- Conditions
- Toxic Shock Syndrome Staphylococcal
- Keywords
- Staphylococcal enterotoxin B, vaccine, Staphylococcus aureus, toxic shock syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.01 mcg intramuscular. |
| Cohort 2 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.1 mcg intramuscular. |
| Cohort 3 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 0.5 mcg intramuscular. |
| Cohort 4 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 2.5 mcg intramuscular. |
| Cohort 5 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 10 mcg intramuscular. |
| Cohort 6 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineSingle dose of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 20 mcg intramuscular. |
| Cohort 7 | Experimental | Drug: Aluminum hydroxide, Biological: STEBVax vaccineTwo doses of staphylococcal enterotoxin B vaccine (STEBVax) in Alhydrogel adjuvant at 20 mcg intramuscular 21 days apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (46 listed)
- History of any of the following medical illnesses:
- Any clinically significant abnormality including but not limited to:
- 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.
- Have a positive urine drug screen.
- For women, positive serum pregnancy test within 45 days and urine pregnancy test within 24 hours of administering STEBVax at days 0 and for the highest dose group who receive two doses of vaccine, on day 21.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aluminum hydroxideSingle 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. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| STEBVax vaccineSingle 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 | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Data describing safety of Staphylococcal Enterotoxin B Vaccine (STEBVax) (clinical observations and clinical laboratory measurements) given in one of several escalating doses.
Time frame: Through Day 56.
1 secondary outcome
The rate and titer of seroconversion with serum immunoglobulin G (IgG) anti-Staphylococcus aureus enterotoxin B antibodies by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 56 and, for the two-dose group, day 77 (56 days after the second dose).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Derived from this study: PubMed 27707765Chen 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.
Related trials for Toxic Shock Syndrome Staphylococcal
RecruitingObservational study
Prodromes of Menstrual Staphylococcal Toxic Shock
Toxic Shock Syndrome Staphylococcal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aluminum hydroxide and STEBVax vaccine in people with Toxic Shock Syndrome Staphylococcal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data describing safety of Staphylococcal Enterotoxin B Vaccine (STEBVax) (clinical observations and clinical laboratory measurements) given in one of several escalating doses. (time frame: Through Day 56.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.