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

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ClinicalTrials.gov Identifier: NCT01852591
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : April 4, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: PCV 13 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : February 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852591


Locations
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United States, Florida
H.Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Frederick L Locke, MD H. Lee Moffitt Cancer Center and Research Institute
More Information
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Additional Information:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01852591    
Other Study ID Numbers: MCC-16727
First Posted: May 13, 2013    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: February 2, 2017
Last Verified: December 2016
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
autologous transplant
multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs