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S. Aureus Vaccine for Soft Tissue Infections
Study Summary
This trial is testing a vaccine for Staphylococcus aureus, both in healthy adults and in adults who have recently had a skin or soft tissue infection from this bacteria. The trial will assess the safety, immunogenicity (ability to produce immunity), and efficacy (ability to prevent infection) of the vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 64 years old and ready for my first vaccination.I am taking long-term immune system altering medications.I am a woman who cannot become pregnant.I have a condition that causes prolonged bleeding.I have uncontrolled neurological disorders or seizures.I am a woman who can have children and have used birth control effectively.I cannot have shots or blood taken due to my health condition.I am not on long-term immune system drugs.I have a serious long-term illness.I have been vaccinated against S. aureus.I have health issues that could increase my surgery risks.I am either male or female.I am between 18 and 50 years old.I am currently undergoing or have undergone cytotoxic therapy.I haven't received immunoglobulins or blood products in the last 3 months.I do not have major lung, heart, liver, kidney issues, cancer, type 1 diabetes, or uncontrolled type 2 diabetes.I understand the study procedures and what this study involves.I am at high risk for serious skin infections.I am healthy but suspect or have confirmed a skin infection caused by S. aureus.I am between 18 and 64 years old.I am a woman who cannot become pregnant.I do not have an active illness at the time of screening or injection.I am healthy and can participate in the initial safety assessment of a new treatment.Subjects who can and will comply with the requirements of the protocol.I am between 18 and 50 years old and have not yet received my first vaccination.
- Group 1: Placebo Group 1b
- Group 2: Placebo Group 2b
- Group 3: Half dose adj Group 3a
- Group 4: Placebo Group 3b
- Group 5: Full dose adj Group 4a
- Group 6: Placebo Group 4b
- Group 7: Half dose non-adj Group 1a
- Group 8: Full dose non-adj Group 2a
- Group 9: Vaccine Group 5a
- Group 10: Placebo Group 5b
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are currently participating in this medical trial?
"Affirmative. Clinicaltrials.gov reveals that the medical trial, which was initially posted on June 29th 2020, is actively recruiting participants. The project requires 632 people to be recruited from 16 different sites."
Is geriatric participation accepted in this investigative trial?
"To qualify for this clinical trial, applicants must fall between the ages of 18 and 64. There are 199 trials available to those under 18 years old, as well as 608 studies dedicated to patients over 65."
Are there any vacant slots left in this clinical research?
"Affirmative. According to clinicaltrials.gov, this experiment which was originally advertised on June 29 2020 is currently recruiting participants. The research necessitates 632 volunteers from 16 separate locales."
How many medical venues are currently executing this clinical investigation?
"This clinical trial is offered at 16 centres throughout the United States, including Decatur, Southfield and Blackfoot. To ease travel requirements during participation, it's recommended to select the facility closest to you upon enrollment."
Am I eligible to enroll in this research endeavor?
"This investigation seeks 632 individuals suffering from communicable illnesses, ranging in age between 18 and 64. Furthermore, potential participants must comprehend the nature of the study, provide written or witnessed informed consent, be able to comply with protocol requirements (i.e., complete diary cards & attend follow-up visits), satisfy screening criteria, possess non-childbearing potential (if female) as well as have practiced adequate contraception for a full month prior to enrolment. Finally they would need verification via pregnancy test on day of their enrolment."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 1 Day
Most responsive sites:
- GSK Investigational Site: < 24 hours
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