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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

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 13, 2013
Results First Submitted Date  ICMJE January 28, 2016
Results First Posted Date  ICMJE April 4, 2016
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2013)
Efficacy [ Time Frame: 180 days ]
Efficacy based on immunologic response pre/post-vaccination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Biological: PCV 13
Other Names:
  • Prevnar
  • pneumococcal conjugate vaccine
Study Arms  ICMJE 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
Intervention: Biological: PCV 13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2014)
8
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2013)
5
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852591
Other Study ID Numbers  ICMJE MCC-16727
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederick L Locke, MD H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP