7-valent Pneumococcal Conjugated Vaccination (PCV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00885625
First received: April 20, 2009
Last updated: July 14, 2010
Last verified: June 2010
  Purpose

Hypothesis: the efficacy of 2 doses 7-valent PCV is equivalent to 1 dose 7-valent PCV.


Condition Intervention Phase
Invasive Pneumococcal Disease
Biological: 7-valent pneumococcal conjugated vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 1-Year Longitudinal Follow-up Study of Serologic Responses to 7-valent Pneumococcal Conjugated Vaccination and Opsonophagocytic Activities for Streptococcus Pneumoniae Among Patients With Human Immunodeficiency Virus Infection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 2-fold increase of antibody titers specific to pneumococcal serotypes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antibody titers specific to pneumococcal serotypes larger than 0.35ug/ml All-cause pneumonia [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 7-valent pneumococcal conjugated vaccine
    7-valent pneumococcal conjugated vaccine is given twice with 4 weeks apart
    Other Name: Prevenar (Wyeth)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected patients with age >18 years

Exclusion Criteria:

  • concurrent immunosuppressant use
  • Pregnant women
  • receipt of other vaccine within 3 months
  • active opportunistic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885625

Contacts
Contact: Chien-Ching Hung, MD, MSc 886-2-23123456 ext 67552 hcc0401@ntu.edu.tw
Contact: Ching-Lan Lu, MD 886-2-23123456 ext 67552 syrupnicole@hotmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chien-Ching Hung, MD, MSc    886-2-23123456 ext 67552    hcc0401@ntu.edu.tw   
Contact: Ching-Lan Lu, MD    886-2-23123456 ext 67552    syrupnicole@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Chien-Ching Hung, MD, MSc National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Hung Chien-Ching, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00885625     History of Changes
Other Study ID Numbers: 200805005M
Study First Received: April 20, 2009
Last Updated: July 14, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
invasive pneumococcal disease
pneumococcal conjugated vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014