NCT01852591 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2017-02-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Immune Response

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outcome · POSTED

CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

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outcome · POSTED

CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

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outcome · POSTED

CD8+CD107a+, Best Response Against Vaccine (CRM 197)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Biological: PCV 13
label
PCV 13
type
EXPERIMENTAL

interventions

arm Group Labels
PCV 13
name
PCV 13
other Names
Prevnar
pneumococcal conjugate vaccine
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Number of Participants With Immune Response
time Frame
30 Days Post Vaccine

secondary Outcomes

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.
measure
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
time Frame
30 Days Post Vaccine
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.
measure
CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
time Frame
30 Days Post Vaccine
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.
measure
CD8+CD107a+, Best Response Against Vaccine (CRM 197)
time Frame
30 Days Post Vaccine

Full study description

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.

Source references