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PneumoniaPhase 1/2NCT00169234

Pneumococcal Adult-dose Ranging Immunization Study

A Phase 1/2 study testing PCV7, Prevnar® and Pneumovax 23 in people with Pneumonia, run by Kaiser Permanente at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only. Read more about this study

Who is it for?
Ages 70 to 79 years
Conditions the study is for
Pneumonia
What is being tested?
PCV7, Prevnar® and Pneumovax 23
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
2 sitesUnited States
Study dates
May 2003to Feb 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 79 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 70 through 79 years (up to the day prior to the 80th birthday)
  • Previously received exactly one dose of PPV23, and that dose was received on or after their 65th birthday and at least 5 years before the date of study enrollment
  • Expected to reside in the area for at least 13 months
  • Able to understand and give informed consent
  • Able to perform study procedures
  • Able to be contacted by telephone for follow-up on adverse events

Who cannot join

  • Received >=2 doses of PPV23 prior to study enrollment.
  • Living non-independently in an institutional setting, such as a nursing home. Persons living independently in adult residence communities will be eligible.
  • Use of any investigational vaccine within the past 30 days or planned use during the study period.
  • Current or planned participation in a research study of an investigational drug. Participation in research studies that involve use of licensed drugs, for either approved or investigational indications, will be permitted with the approval of the site PI, as will participation in research studies that do not involve medications.
  • Current use or previous chronic administration, defined as >=14 days during the previous six months, of immunosuppressants or other immune-modifying drugs. (For oral or injected corticosteroids, the immune-modifying dose is defined as prednisone or its equivalent >=10 mg/day). Topical steroids are allowed.
  • Current use of high doses of inhaled steroids, defined as per Table 3.
Show all 19Show fewer
  • Use of cytotoxic therapy in the previous 5 years.
  • Plans to receive cytotoxic therapy during the study period.
  • Receipt of parenteral immunoglobulin or blood products within three months of study.
  • Plans to receive parenteral immunoglobulin or blood products within the study period.
  • Current ongoing use of warfarin or heparin or has a bleeding disorder, such as ITP.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Anatomic or known functional asplenia.
  • History of a hematologic malignancy or a pre-malignant condition (i.e., leukemia, lymphoma, multiple myeloma, myelodysplasia).
  • Active neoplastic disease, excluding local skin cancer or other malignancies (e.g. prostate cancer) that are stable in the absence of immunosuppressive/cytotoxic or radiation therapy.
  • End-stage liver disease or hepatic failure (as diagnosed by a physician or evidenced by a history within the last 10 years of bleeding esophageal varices, ascites, or hepatic encephalopathy).
  • Renal failure, as evidenced by current or expected dialysis or known creatinine of >=2.5 ug/ml.
  • Known hypersensitivity to PPV23 or to any component of PPV23 or PCV7, including aluminum phosphate or diphtheria protein.
  • Presence of any other condition or impairment that in the opinion of the investigator is likely to compromise the participant's ability to complete the study procedures.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Group Health Research Institute

    Seattle, Washington, 98101

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: Immunogenicity and Safety of Varying Doses of a 7-valent Conjugate Pneumococcal Vaccine in Adults 70-79 Years of Age Who Were Previously Vaccinated With the 23-valent Pneumococcal Polysaccharide Vaccine

The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.

Read the detailed description

The purpose of this prospective randomized study is to assess the safety, post-vaccination antibody response, and memory response to a subsequent polysaccharide challenge of varying doses of PCV7 compared with the standard dose of PPV23 in immunocompetent adults 70-79 years of age who were previously vaccinated with PPV23 at age 65 years or above and at least 5 years previously. The study will be conducted among a total of 220 persons recruited from GHC and the Seattle VAMC. Participants will be randomized into one of 5 study groups with 44 participants per group. The antigen content of PCV7 will be varied by administration of different volumes of the licensed pediatric formulation of that vaccine. Four groups will receive one of four volumes (0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL) of the licensed pediatric formulation of PCV7 followed 12 months later by administration of a challenge 0.1 mL dose of PPV23 to assess the induction of immunologic memory. The comparison group will receive the standard 0.5 mL dose of PPV23 following 12 months later by administration of a 0.1 mL dose of PPV23.

Conditions
Pneumonia
Being tested
PCV7, Prevnar®, Pneumovax 23
Keywords
Pneumococcal disease, Vaccination, Immunization, PPV23, PCV7
Medical subject headings
Pneumonia, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCV7, Prevnar®Biological

    Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.

  • Pneumovax 23Biological

    Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.

Study groups in NCT00169234
Study groupRoleWhat they receive
0.1mL Pneumococcal Conjugate VaccineExperimentalParticipants in this group were randomized at enrollment to receive 0.1mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Receives: Biological: PCV7, Prevnar®; Biological: Pneumovax 23
0.5mL Pneumococcal Conjugate VaccineExperimentalParticipants in this group were randomized at enrollment to receive 0.5mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Receives: Biological: PCV7, Prevnar®; Biological: Pneumovax 23
1.0mL Pneumococcal Conjugate VaccineExperimentalParticipants in this group were randomized at enrollment to receive 1.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Receives: Biological: PCV7, Prevnar®; Biological: Pneumovax 23
2.0mL Pneumococcal Conjugate VaccineExperimentalParticipants in this group were randomized at enrollment to receive 2.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Receives: Biological: PCV7, Prevnar®; Biological: Pneumovax 23
0.5mL Pneumococcal Polysacc VaccineExperimentalParticipants in this group were randomized at enrollment to receive 0.5mL Pneumovax 23 at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Receives: Biological: Pneumovax 23

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the immunologic response to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.

    Measured: Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination

Secondary outcomes (1)

  1. To evaluate the safety to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.

    Measured: During the 13 month study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startMay 2003
  3. Primary completionFeb 2005
  4. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169234
Sponsor's protocol ID
CDC Protocol 3848
Other IDs
CDC Task Order 0957-045
Status last verified
Oct 2017
First submitted
9 Sep 2005
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, Starkovich PT, Dunstan M, Carste B, Shay DK, Baggs J, Carlone GM. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007 May 16;25(20):4029-37. doi: 10.1016/j.vaccine.2007.02.062. Epub 2007 Mar 12.

    PubMed 17391816

  • Jackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, Nelson JC, Feikin DR, Shay DK, Baggs J, Carste B, Nahm MH, Carlone G. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2005 May 25;23(28):3697-703. doi: 10.1016/j.vaccine.2005.02.017.

    PubMed 15882530

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PCV7, Prevnar® and Pneumovax 23 in people with Pneumonia, run by Kaiser Permanente at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the immunologic response to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults. (time frame: Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169234, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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