Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial

February 13, 2023 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine

A Randomized, Multi-Center Trial to Evaluate the Safety & Immunogenicity of Staphylococcus Aureus Toxoids, rAT and rLukS-PV, in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult males or females, DoD beneficiaries, including active duty members, 18-55 years of age.
  • Negative urine pregnancy test for female subjects of child bearing potential (negative test within 24 hours prior to investigational product injection) or documented surgical sterility.
  • Female subjects of child-bearing potential must use an acceptable method of birth control, as determined by the PI.
  • Willingness to participate in this study as evidenced by written informed consent.

Exclusion Criteria:

  • Prior receipt of S. aureus rAT or rLukS-PV
  • Known S. aureus infection requiring medical treatment within the 3 months prior to investigational drug product injection
  • Known active viral or bacterial infection
  • Seropositivity for HIV infection
  • Known or suspected abuse of prescribed or illicit drugs, or alcohol in the past year
  • Use of any new medications (except oral contraceptives, over-the-counter medications, or vitamin supplements) within the 7 days prior to investigational drug product injection
  • Use of investigational drugs, vaccines, or devices during the study or within the 30 days prior to each dose of investigational drug product injection, or anticipated use of such items during the study
  • Use of systemic steroids (any dose) or high daily dose inhaled steroids within the last month. Use of low or medium daily dose inhaled, intranasal, or low potency topical steroid creams/ointments is allowed unless such medication was begun within the previous 7 days.
  • History of a bleeding or coagulation disorder; or use of anti-coagulant medications within 7 days prior to investigational product injection
  • Actively breastfeeding
  • Presence of grade I or higher abnormality in laboratory or vital signs parameter at time of screening
  • Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline Placebo
Biological: Placebo
Placebo saline
Experimental: Active Vaccine
Monovalent rAT or Monovalent rLukS-PV or Bivalent rLukS-PV / rAT
Biological: Monovalent rAT
10, 25, 50 or 100 μg
Biological: Monovalent rLukS-PV
10, 25, 50 or 100 μg
Biological: Bivalent rLukS-PV / rAT
10, 25 or 50 μg
Placebo Comparator: Placebo with Alum
Biological: Placebo with adjuvant
Placebo with adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports
Time Frame: Up to 6 months
Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary
Up to 6 months
Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population
Time Frame: Up to 3 months
Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Nabi Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCRP-035/Nabi-6801
  • Nabi-W81XWH-09-2-0151
  • USAMRAA Grant #DR081318P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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