Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant (PCV13)

December 7, 2016 updated by: H. Lee Moffitt Cancer Center and Research Institute

Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma

There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H.Lee Moffitt Cancer Center & Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with confirmed multiple myeloma
  • Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant

Exclusion Criteria:

  • Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
  • HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
  • Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
  • Active central nervous system (CNS) malignancy
  • Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy.
  • History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
  • Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
  • Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
  • Active or uncontrolled infection
  • Diffusing lung capacity oxygenation (DLCO) <50 %
  • Left ventricular ejection fraction (LVEF) <40%
  • Bilirubin >2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCV 13
Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant
Biological: PCV 13
Other Names:
  • Prevnar
  • pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Immune Response
Time Frame: 30 Days Post Vaccine
Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.
30 Days Post Vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Time Frame: 30 Days Post Vaccine
Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.
30 Days Post Vaccine
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Time Frame: 30 Days Post Vaccine
Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.
30 Days Post Vaccine
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Time Frame: 30 Days Post Vaccine
Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.
30 Days Post Vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Frederick L Locke, MD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-16727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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