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

NCT ID: NCT01852591

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-10-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

PCV 13

Intervention Type: BIOLOGICAL

Interventions

PCV 13

Intervention Type: BIOLOGICAL

Other Intervention Names

Prevnar; pneumococcal conjugate vaccine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick L Locke, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H.Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Countries

United States

Related Links

http://www.moffitt.org

H.Lee Moffitt Cancer Center \& Research Institute

http://www.nature.com/bmt/journal/vaop/ncurrent/full/bmt2015239a.html

Bone Marrow Transplantation advance online publication 12 October 2015; doi: 10.1038/bmt.2015.239

Other Identifiers

MCC-16727

Identifier Type: -

Identifier Source: org_study_id