Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
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
1 other identifier
interventional
80
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Aug 2004
Shorter than P25 for phase_1 rheumatoid-arthritis
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedApril 13, 2011
April 1, 2011
5 months
January 19, 2006
April 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
Secondary Outcomes (1)
Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
Study Arms (4)
Group 1
EXPERIMENTALGroup 2
ACTIVE COMPARATORGroup 3
ACTIVE COMPARATORGroup 4
ACTIVE COMPARATORInterventions
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Qutintiles Phase I Services
Lenexa, Kansas, United States
Parexel International Corp
Baltimore, Maryland, United States
PPD Development
Austin, Texas, United States
Related Publications (1)
Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.
PMID: 17425783DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 20, 2006
Study Start
August 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
April 13, 2011
Record last verified: 2011-04