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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279734

Enrollment

Registered

2006-01-20

Start date

2004-08-31

Completion date

2005-01-31

Last updated

2011-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

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.

Interventions

DRUGTetanus + pnemococcal vaccines alone

0 mg + vaccines, Single dose, 28 days.

DRUGAbatacept + vaccines

Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.

DRUGAbatacept + Vaccines

parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026