Skip to main content
OpenTrials
Completed

NCT Number: NCT00279734

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qutintiles Phase I Services, Lenexa, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetanus + pnemococcal vaccines alone

Drug

0 mg + vaccines, Single dose, 28 days.

Abatacept + vaccines

Drug

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

Other names: Orencia

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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 20, 2006
Registry last updated
Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.