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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Multiple Myeloma

Treatments: Biological: PCV 13

Study type: Interventional

Funder types: Other

Identifiers

NCT01852591

MCC-16727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

PCV 13

Experimental 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

Treatment:

Biological: PCV 13