Advertisement

Topics

Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial

2014-08-27 03:18:04 | BioPortfolio

Summary

This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body. The purpose of this study is to find the right dose of a new vaccine that is safe and produces a good immune response (how well your body recognizes and defends itself against harmful foreign substances). There are two Staphylococcus aureus toxoids (components or antigens) under investigation in this study; one of them is a protein known as rAT and the other is a protein known as rLukS-PV. They are being developed to see if they are effective at preventing infections caused by the bacteria Staphylococcus aureus.

Description

Staphylococcus aureus is a leading cause of skin and soft tissue infections. Antibiotic resistance, such as seen with new community-acquired methicillin-resistant strains, presents a major challenge in treating and preventing these infections. Therefore, a preventative vaccine is considered a potentially better approach.

This study assesses the safety and immunogenicity of monovalent and bivalent S. aureus vaccine components. Healthy adult subjects will be randomized to receive 1 dose of monovalent or bivalent toxoid vaccine, or placebo in a dose escalation schedule.

Antigen-specific antibody will be measured by ELISA in sera collected for three months after injection. Safety data will be collected as 7 day reactogenicity diaries after each injection, adverse events and Staphylococcus aureus and skin and soft tissue infections will be collected through Day 84, and serious adverse events and chronic illnesses will be collected for the full 6 month study period.

To evaluate the possible utility of booster doses, the cohort receiving the highest dose of bivalent antigen will have a 2nd dose administered at Day 84, with a new 7-day reactogenicity diary and sera collected after the 2nd dose. All subjects will be followed up with a 6 month phone call after vaccination or booster.

The total subject observation period will be for 24 weeks from Day 0, plus 12 additional weeks for the cohorts that receive a 2nd dose. With a recruitment period of 4 months, the study duration is expected to be approximately 13 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Staphylococcus Aureus

Intervention

Monovalent rAT, Monovalent rLukS-PV, Bivalent rLukS-PV / rAT, Placebo with adjuvant, Placebo

Location

Brooke Army Medical Center
Fort Sam Houston
Texas
United States
78234

Status

Recruiting

Source

Uniformed Services University of the Health Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:04-0400

Clinical Trials [649 Associated Clinical Trials listed on BioPortfolio]

Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using ...

A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1...

Immunogenicity of Monovalent Inactivated Influenza A/H7N9 Virus Vaccine.

This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years o...

A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched pept...

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: - To describe the immunogenicity of the candidate vaccines ...

PubMed Articles [1835 Associated PubMed Articles listed on BioPortfolio]

Design of a true bivalent ligand with picomolar binding affinity for a G protein-coupled receptor homodimer.

Bivalent ligands have emerged as chemical tools to study G protein-coupled receptor dimers. Using a combination of computational, chemical, and biochemical tools, here we describe the design of bivale...

Monovalent cation transporters at the plasma membrane in yeasts.

Maintenance of proper intracellular concentrations of monovalent cations, mainly sodium and potassium, is a requirement for survival of any cell. In the budding yeast Saccharomyces cerevisiae, monoval...

Comparing monovalent and combination hepatitis B vaccine outcomes in children delivered by mothers with chronic hepatitis B.

We compared the vaccine effectiveness of monovalent and combination hepatitis B vaccine regimens in infants born to chronic hepatitis B carrier mothers.

Immunogenicity and Safety of Monovalent Acellular Pertussis Vaccine at Birth: A Randomized Clinical Trial.

An alternative option to maternal vaccination to prevent severe pertussis in infants is vaccination at birth. Data are needed on the immunogenicity and safety of a birth dose of monovalent acellular p...

Efficient enzymatic ligation of inhibitor cystine knot spider venom peptides: using sortase A to form double-knottins to probe voltage-gated sodium channel NaV1.7.

Gating modifier toxins from spider venom are disulfide-rich peptides that typically comprise a stabilizing inhibitory cystine knot (ICK). These knottin peptides are being pursued as therapeutic leads ...

Medical and Biotech [MESH] Definitions

An oxyacid of chlorine (HClO) containing monovalent chlorine that acts as an oxidizing or reducing agent.

Positively charged atoms, radicals or group of atoms with a valence of plus 1, which travel to the cathode or negative pole during electrolysis.

Ion channels that are regulated by cyclic GMP or cyclic AMP binding and contain six transmembrane segments and an ion conducting pore that passes monovalent cations. They are expressed in OLFACTORY NERVE cilia and in PHOTORECEPTOR CELLS and some PLANTS. They are blocked by DILTIAZEM.

A class of ionotropic glutamate receptors characterized by affinity for N-methyl-D-aspartate. NMDA receptors have an allosteric binding site for glycine which must be occupied for the channel to open efficiently and a site within the channel itself to which magnesium ions bind in a voltage-dependent manner. The positive voltage dependence of channel conductance and the high permeability of the conducting channel to calcium ions (as well as to monovalent cations) are important in excitotoxicity and neuronal plasticity.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

More From BioPortfolio on "Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial