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

Multiple Myeloma Clinical Trial

— PCV13  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01852591
• Other study ID #: MCC-16727
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2013
• Last updated: December 7, 2015
• Start date: February 2013
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: October 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• PCV13

Locations

Country	Name	City	State
United States	H.Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Immune Response	1. Evaluations: Analysis of Interferon-? producing T cells in enzyme-linked immunospot (ELISPOT) assays in response to diphtheria component of the vaccine (protein CRM197) [Positive response - post-vaccination result higher than pre-vaccination values AND values higher in comparison to control (ova peptide) by at least 2 times standard deviation AND with a value of at least 10 spots per well]; Analysis of T-cell proliferation using a carboxyfluorescein diacetate succinimidyl ester (CFSE) flow cytometry assay in response to diphtheria component of the vaccine (protein CRM197) [Positive response - a post-vaccination results higher than the pre-vaccination values AND values that are higher in comparison to control (Ova peptide) by at least 2 times the standard deviation]; Measurement of T-cell dependent anti-pneumococcal immunoglobulin G (IgG) antibody titers by conventional ELISA to serotypes 6B, 14, and 23F [Positive response - anti-pneumococcal antibody concentration >/= 1 ?g/ml].	180 days	No

External Links

•   H.Lee Moffitt Cancer Center & Research Institute