NCT02700841

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation

A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.

Detailed description

PRIMARY OBJECTIVES: 1. To compare the cellular and humoral vaccine response post-transplant between the two arms by performing Elisa, and T-cell enzyme-linked immunospot (ELISPOT) assays 2. To determine the feasibility and safety of this approach SECONDARY OBJECTIVES: 1. To compare post-transplant recovery of innate and adaptive immune cells (CD8, CD4, CD19, NK, γδ T-cells), in addition to T-cell phenotype markers between the two arms. 2. To compare post-transplant recovery of T-regs and MDSCs between the two arms. 3. To compare progression free survival (PFS) at 2 years post-transplant

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Melphalan	Given IV
PROCEDURE	Peripheral Blood Stem Cell Transplantation--CD34 HSCT	Undergo autologous CD34 HSCT
PROCEDURE	Peripheral Blood Stem Cell Transplantation--AHSCT	Undergo AHSCT
BIOLOGICAL	T Cell-Depleted Hematopoietic Stem Cell Transplantation	Undergo autologous CD34 HSCT
BIOLOGICAL	Tetanus Toxoid Vaccine	Given IM

Timeline

• Start date: 2020-01-09
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2016-03-07
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study