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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Multiple Myeloma
Intervention Biological: PCV 13
Enrollment 8
Recruitment Details Participants were enrolled at Moffitt Cancer Center between March 2013 and July 2014.
Pre-assignment Details  
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 8
Completed 5
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Not Evaluable at Time of Analysis             1
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  62.5%
>=65 years
3
  37.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
61.625
(52 to 68)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Number of Participants With Immune Response
Hide Description 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.
Time Frame 30 Days Post Vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants.
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
CD4+CTV-IFN-gamma+, 5
CD8+CTV-IFN-gamma+, 5
CD8+CD107a+ 5
2.Secondary Outcome
Title CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Hide Description 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.
Time Frame 30 Days Post Vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants.
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of CD4 cells
Highest % of CD4 cells Pre-vaccine 0.051
Best Response % of CD4 cells Day +30 40.7
3.Secondary Outcome
Title CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Hide Description 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.
Time Frame 30 Days Post Vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants.
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of CD8 cells
Highest % of CD8 cells Pre-vaccine 0.00
Best Response % of CD8 cells Day +30 2.69
4.Secondary Outcome
Title CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Hide Description 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.
Time Frame 30 Days Post Vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants.
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of CD8 cells
Highest % of CD8 cells Pre-vaccine 1.19
Best Response % of CD8 cells Day +30 8.94
Time Frame 1 year, 5 months
Adverse Event Reporting Description All participants who received treatment.
 
Arm/Group Title Experimental: PCV 13
Hide Arm/Group Description 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.
All-Cause Mortality
Experimental: PCV 13
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Experimental: PCV 13
Affected / at Risk (%) # Events
Total   3/7 (42.86%)    
Cardiac disorders   
Cardiac disorders - Other, Orthostasis  1  1/7 (14.29%)  1
Sinus bradycardia  1  1/7 (14.29%)  2
Gastrointestinal disorders   
Abdminal pain  1  1/7 (14.29%)  1
Nausea  1  1/7 (14.29%)  1
Vomiting  1  1/7 (14.29%)  1
General disorders   
Fatigue  1  1/7 (14.29%)  1
Infections and infestations   
Lung infection  1  1/7 (14.29%)  1
Urinary tract infection  1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/7 (14.29%)  1
Dehydration  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/7 (14.29%)  1
Vascular disorders   
Hypotension  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: PCV 13
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Cardiac disorders   
Atrial fibriliation  1  2/7 (28.57%)  2
Sinus bradycardia  1  1/7 (14.29%)  1
Ear and labyrinth disorders   
Ear pain  1  1/7 (14.29%)  1
Hearing impaired  1  1/7 (14.29%)  1
Middle ear inflammation  1  1/7 (14.29%)  1
Vertigo  1  1/7 (14.29%)  1
Endocrine disorders   
Hypothyroidism  1  1/7 (14.29%)  1
Gastrointestinal disorders   
Constipation  1  2/7 (28.57%)  2
Dry mouth  1  1/7 (14.29%)  1
Nausea  1  1/7 (14.29%)  2
Gastrointestinal disorders - Other, Heartburn  1  1/7 (14.29%)  2
Rectal pain  1  1/7 (14.29%)  1
Vomiting  1  1/7 (14.29%)  2
General disorders   
Fever  1  5/7 (71.43%)  5
Injection site reaction  1  4/7 (57.14%)  9
Edema limbs  1  2/7 (28.57%)  2
Chills  1  1/7 (14.29%)  1
Fatigue  1  1/7 (14.29%)  1
Flu like symptoms  1  1/7 (14.29%)  1
Non-cardiac chest pain  1  1/7 (14.29%)  1
Infections and infestations   
Papulopustular rash  1  2/7 (28.57%)  2
Lung infection  1  1/7 (14.29%)  1
Investigations   
Alanine aminotransferase increased  1  1/7 (14.29%)  1
Alkaline phosphatase increased  1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Bone pain  1  2/7 (28.57%)  2
Generalized muscle weakness  1  1/7 (14.29%)  1
Nervous system disorders   
Headache  1  5/7 (71.43%)  5
Peripheral sensory neuropathy  1  2/7 (28.57%)  2
Amnesia  1  1/7 (14.29%)  1
Dizziness  1  1/7 (14.29%)  1
Psychiatric disorders   
Insomnia  1  3/7 (42.86%)  3
Hallucinations  1  2/7 (28.57%)  2
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/7 (14.29%)  1
Dyspnea  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  2/7 (28.57%)  2
Dry skin  1  1/7 (14.29%)  1
Erythema multiforme  1  1/7 (14.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frederick Locke, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3509
EMail: frederick.locke@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01852591    
Other Study ID Numbers: MCC-16727
First Submitted: May 9, 2013
First Posted: May 13, 2013
Results First Submitted: January 28, 2016
Results First Posted: April 4, 2016
Last Update Posted: February 2, 2017