Trial Outcomes & Findings for Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant (NCT NCT01852591)
NCT ID: NCT01852591
Last Updated: 2017-02-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
30 Days Post Vaccine
Results posted on
2017-02-02
Participant Flow
Participants were enrolled at Moffitt Cancer Center between March 2013 and July 2014.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Not Evaluable at Time of Analysis
|
1
|
Baseline Characteristics
Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant
Baseline characteristics by cohort
| Measure |
Experimental: PCV 13
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Age, Continuous
|
61.625 years
n=39 Participants
|
|
Gender
Female
|
2 Participants
n=39 Participants
|
|
Gender
Male
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 30 Days Post VaccinePopulation: All evaluable participants.
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.
Outcome measures
| Measure |
Experimental: PCV 13
n=5 Participants
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.
|
|---|---|
|
Number of Participants With Immune Response
CD4+CTV-IFN-gamma+,
|
5 participants
|
|
Number of Participants With Immune Response
CD8+CTV-IFN-gamma+,
|
5 participants
|
|
Number of Participants With Immune Response
CD8+CD107a+
|
5 participants
|
SECONDARY outcome
Timeframe: 30 Days Post VaccinePopulation: All evaluable participants.
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.
Outcome measures
| Measure |
Experimental: PCV 13
n=5 Participants
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.
|
|---|---|
|
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Highest % of CD4 cells Pre-vaccine
|
0.051 percentage of CD4 cells
|
|
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Best Response % of CD4 cells Day +30
|
40.7 percentage of CD4 cells
|
SECONDARY outcome
Timeframe: 30 Days Post VaccinePopulation: All evaluable participants.
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.
Outcome measures
| Measure |
Experimental: PCV 13
n=5 Participants
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.
|
|---|---|
|
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Highest % of CD8 cells Pre-vaccine
|
0.00 percentage of CD8 cells
|
|
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
Best Response % of CD8 cells Day +30
|
2.69 percentage of CD8 cells
|
SECONDARY outcome
Timeframe: 30 Days Post VaccinePopulation: All evaluable participants.
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.
Outcome measures
| Measure |
Experimental: PCV 13
n=5 Participants
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.
|
|---|---|
|
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Highest % of CD8 cells Pre-vaccine
|
1.19 percentage of CD8 cells
|
|
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
Best Response % of CD8 cells Day +30
|
8.94 percentage of CD8 cells
|
Adverse Events
Experimental: PCV 13
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: PCV 13
n=7 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac disorders - Other, Orthostasis
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Abdminal pain
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
Other adverse events
| Measure |
Experimental: PCV 13
n=7 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Number of events 5 • 1 year, 5 months
All participants who received treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Nervous system disorders
Amnesia
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Fever
|
71.4%
5/7 • Number of events 5 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Injection site reaction
|
57.1%
4/7 • Number of events 9 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Edema limbs
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Heartburn
|
14.3%
1/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Infections and infestations
Papulopustular rash
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Infections and infestations
Lung infection
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Psychiatric disorders
Insomnia
|
42.9%
3/7 • Number of events 3 • 1 year, 5 months
All participants who received treatment.
|
|
Psychiatric disorders
Hallucinations
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Cardiac disorders
Atrial fibriliation
|
28.6%
2/7 • Number of events 2 • 1 year, 5 months
All participants who received treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • 1 year, 5 months
All participants who received treatment.
|
Additional Information
Frederick Locke, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3509
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place