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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00279734

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

26.7

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tetanus + pnemococcal vaccines alone Drug: Abatacept + vaccines Drug: Abatacept + vaccines Drug: Abatacept + Vaccines	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Qutintiles Phase I Services	Lenexa	Kansas	United States
2	Parexel International Corp	Baltimore	Maryland	United States
3	PPD Development	Austin	Texas	United States