IRB #

STUDY00018724

Title

A Phase 3, Randomized, Double-blind, Active Comparator controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

Principal Investigator

Lynne Strasfeld

Study Purpose

This study tests a new vaccine (V114) for protection against pneumococcal disease (PD), which can cause infections in people who may have weak immune systems. Patients who are recovering from a hematopoietic stem cell transplant are given vaccines to help protect against PD infection. The study will evaluate the safety of the vaccine, how well it is tolerated, and how well the study vaccine works compared to the usual vaccines given after hematopoietic stem cell transplant (HCST) to protect from PD.

Medical Condition(s)

Bone marrow transplant
Infection prevention
Post-transplant
Infection prophylaxis
Vaccine
Pneumococcal Disease
PD

Eligibility Criteria

Inclusion criteria:
- At least 18 years old
- Male or female
- Females must not be pregnant, breastfeeding, and either unable to become pregnant or agree to use effective contraceptive methods while participating in the study

- Subjects must have received first bone marrow transplant with an HLA compatible donor including hapoloidentical and mismatched (related or unrelated) donors, 90-180 days before randomization.
- The bone marrow transplant must have been given for one of the following diseases:
-- acute lymphoblastic leukemia (ALL) in first or second remission
-- acute myeloid leukemia (AML) in first or second remission
-- chronic myeloid leukemia (CML) in first chronic or accelerated phase
-- Hodgkin's lymphoma
-- non-Hodgkin's lymphoma (NHL)
-- myelodysplastic syndrome (MDS)
-- myelofibrosis
-- myeloproliferative diseases
-- aplastic anemia
-- sickle cell disease

- Subjects must be expected to survive more than 12 months after their transplant
- Subjects must be clinically stable

Exclusion criteria:
- Subjects cannot have had a previous allogeneic bone marrow transplant
- Subjects cannot have had ex-vivo (outside the body) manipulated grafts such as those with CD34 selection, TCR alpha-beta depletion, or in-vivo (in the body) T cell depletion with alemtuzumab, or a haploidentical transplant with high dose anti-thymocyte globulin
- Patients who received allogeneic transplants for multiple myeloma or nonmalignant diseases (except sickle cell disease and aplastic anemia)
- Persistent or relapsed disease after their bone marrow transplant - History of severe graft-versus-host disease (grade 3 or 4) after allogeneic transplant
- Planned organ transplantation after allogeneic bone marrow transplant
- History of a positive culture test for pneumococcal disease after allogeneic bone marrow transplant
- Known hypersensitivity to any component of the vaccines used in the study
- History of congenital or acquired immunodeficiency
- Coagulation disorder where intramuscular vaccinations are contraindicated
- Cannot have had an illness with fever within 72 hours of receiving the study vaccine
- Impaired liver or kidney as indicated by screening lab tests
- Platelets less than 30K/uL at screening
- Absolute neutrophil count less than 1000/uL at screening
- A woman who can become pregnant with a positive urine or serum pregnancy test
- Cannot have received CAR-T therapy or checkpoint inhibitor directed therapy (such as anti PD-1) after allogeneic transplant
- Cannot have received anti-CD20 B cell targeted therapy (rituximab) after allogeneic transplant
- cannot have received systemic steroids at prednisone dose greater than 0.5 mg/kg/day for 14 consecutive days or more, and has not completed treatment at least 30 days before the study vaccine is given.
- Cannot be scheduled to receive immunoglobulins (IgG) or plasma products within 30 days of study vaccine
- Cannot have a non-study pneumococcal vaccine after allogeneic transplant
- cannot have received any licensed, non-live vaccine within 14 days before receipt of any study vaccine, or is scheduled to receive non-live vaccine within 14 days after receipt of any study vaccine, EXCEPT inactivated influenza vaccine and haemophilus influenza type B (Hib) may be administered, but only if given at least 7 days before and/or at least 7 days after any study vaccine
- Cannot have received any live vaccine within 30 days before being given any study vaccine, and cannot be scheduled to receive any live vaccine within 30 days after being given any study vaccine.
- cannot be currently participating in an interventional clinical study with a study agent within 2 weeks of participating in this study
- Cannot use recreational or illicit drugs or have a recent history of drug or alcohol abuse or dependence
- May not have history or evidence of a condition or circumstance that may pose a risk to the participant by participating in the study
- Cannot have an immediate family member who is involved with this study.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

11 months

Minors Included

No

Contact

Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) ­494-­1080 or trials@ohsu.edu

Sponsor

Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co., Inc.)

Recruitment End

07/31/2021

Compensation Provided

No


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