NCT00239694

Brief Summary

The purpose of this study is to measure how long the improvement in the immune system lasts in older people after they have been vaccinated, and to examine the immune response in older people who get vaccinated a second time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

11.3 years

First QC Date

October 13, 2005

Last Update Submit

July 14, 2015

Conditions

Aging

Keywords

Immune responseAntibody response

Outcome Measures

Primary Outcomes (1)

  • Pre and post vaccination (groups I and II) serum samples

    Day 0, day 28, and 6 months following vaccination and days on each BLSA site visit

Study Arms (2)

1

EXPERIMENTAL

Previously vaccinated

Biological: Pneumococcal Vaccine

2

EXPERIMENTAL

Never vaccinated

Biological: Pneumococcal VaccineBiological: Meningococcal Vaccine

Interventions

Pneumococcal VaccineBIOLOGICAL

One time preventative vaccine

Also known as: Pneumovax
12
Meningococcal VaccineBIOLOGICAL

One time preventative vaccine

Also known as: Menomune
2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Enrolled in the BLSA with at least 2 stored blood samples post vaccination
  • years old or older
  • Previously vaccinated with Pneumovax at least 5 years ago or never vaccinated
  • Willing to receive vaccination with pneumococcal and meningococcal injection
  • Able to provide informed consent
  • Has never received a meningococcal vaccine

You may not qualify if:

  • Hypersensitivity to the pneumococcal or meningococcal vaccine
  • Ever received the Meningococcal vaccine
  • History of non-skin cancer
  • History of myeloproliferative disorder
  • History of HIV
  • Received a Bone Marrow Transplant
  • Taking prednisone (more than 5 mg/day) or other immunosuppressive medication
  • Evidence of severe liver or renal disease (serum creatine \>2.0 mg/dL or Total Bilirubin \>2.0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Aging

Baltimore, Maryland, 21225, United States

Location

Related Publications (3)

  • Hedlund J, Ortqvist A, Konradsen HB, Kalin M. Recurrence of pneumonia in relation to the antibody response after pneumococcal vaccination in middle-aged and elderly adults. Scand J Infect Dis. 2000;32(3):281-6. doi: 10.1080/00365540050165929.

    PMID: 10879599BACKGROUND

  • Musher DM, Luchi MJ, Watson DA, Hamilton R, Baughn RE. Pneumococcal polysaccharide vaccine in young adults and older bronchitics: determination of IgG responses by ELISA and the effect of adsorption of serum with non-type-specific cell wall polysaccharide. J Infect Dis. 1990 Apr;161(4):728-35. doi: 10.1093/infdis/161.4.728.

    PMID: 2319166BACKGROUND

  • Hilleman MR, Carlson AJ Jr, McLean AA, Vella PP, Weibel RE, Woodhour AF. Streptococcus pneumoniae polysaccharide vaccine: age and dose responses, safety, persistence of antibody, revaccination, and simultaneous administration of pneumococcal and influenza vaccines. Rev Infect Dis. 1981 Mar-Apr;3 Suppl:S31-42. doi: 10.1093/clinids/3.supplement_1.s31.

    PMID: 7025159BACKGROUND

MeSH Terms

Interventions

Pneumococcal VaccinesMeningococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Dan L. Longo, MD

    Scientific Director, National Insitute on Aging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

April 1, 2001

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 4, 2015

Record last verified: 2015-07

Locations

US(1)