Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

April 11, 2011 updated by: Bristol-Myers Squibb

An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects

Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • 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
    • Kansas
      • Lenexa, Kansas, United States
        • Qutintiles Phase I Services
    • Maryland
      • Baltimore, Maryland, United States
        • Parexel International Corp
    • Texas
      • Austin, Texas, United States
        • Ppd Development

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Subjects
  • Body Weight between 60 and 100 kg.
  • Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.

Exclusion Criteria:

  • Females who are prgnant or breastfeeding
  • History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
  • Active TB requiring treatment within the previous 3 years.
  • Positive breast cancer screen, PPD test.
  • Vaccination with tetanus or pneumococcal vaccine within 5 years.
  • Vaccination with any live vaccine within 4 weeks.
  • History of drug or alcohol abuse.
  • Any significant allergy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 2
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Other Names:
  • Orencia
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Other Names:
  • Orencia
Experimental: Group 1
Drug: Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
Active Comparator: Group 3
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Other Names:
  • Orencia
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
Other Names:
  • Orencia
Active Comparator: Group 4
Drug: Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.

Secondary Outcome Measures

Outcome Measure
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 11, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-049

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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