A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:3 - Any
Updated:4/6/2019
Start Date:September 12, 2018
End Date:November 10, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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)

This study is designed 1) to describe the safety, tolerability, and immunogenicity of V114
and Prevnar 13™ in pneumococcal vaccine-naïve adult and pediatric recipients of allogeneic
hematopoietic stem cell transplant (HSCT), and 2) to describe the safety and tolerability of
PNEUMOVAX™23 when administered 12 months after HSCT.


Inclusion Criteria:

- Received a human leukocyte antigen (HLA) compatible donor including haploidentical and
mismatched (related or unrelated) first allogeneic HSCT (i.e., bone marrow or
peripheral blood stem cell) 90 to 180 days prior to randomization.

- Received the allogeneic HSCT for 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, myelodysplastic syndrome (MDS), myelofibrosis and
myeloproliferative diseases, and non-malignant disease such as aplastic anemia or
sickle cell disease in participants ≥18 years of age and any non-malignant disease for
participants 3 to <18 years of age.

- Life expectancy >12 months after allogeneic HSCT, according to investigator judgement.

- Clinically stable engraftment according to investigator judgment.

- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least 1 of the following conditions applies: a) not a woman of
childbearing potential (WOCBP) OR b) a WOCBP who agrees to use acceptable
contraceptive methods during the treatment period and for at least 6 weeks after the
last dose of study intervention.

Exclusion Criteria:

- Receipt of a previous allogeneic HSCT.

- Received allogeneic HSCT with ex-vivo graft manipulation, in vivo T cell depletion
with alemtuzumab, or haploidentical allogeneic HSCT with high dose anti-thymocyte
globulin.

- Received allogeneic HSCT for multiple myeloma or, for participants ≥18 years of age
only, for any nonmalignant diseases except sickle cell disease and aplastic anemia.

- Persistent or relapsed primary disease after allogeneic HSCT.

- History of severe GVHD (Grade 3 or 4 GVHD) after allogeneic HSCT.

- Planned organ transplantation after allogeneic HSCT.

- History of culture-positive pneumococcal disease occurring after allogeneic HSCT.

- Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.

- History of acquired immunodeficiency such as documented HIV infection, or anatomic
asplenia.

- Coagulation disorder contraindicating intramuscular vaccinations.

- Severe hepatic impairment (defined as Child-Pugh Class C) at Screening.

- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >5 × upper limit of
normal (ULN) or serum total bilirubin >2.5 × ULN at Screening.

- A WOCBP who has a positive urine or serum pregnancy test before the 1st vaccination.

- Received chimeric antigen receptor T-cell (CAR-T) therapy or checkpoint inhibitor
directed therapy (i.e., anti-Programmed Cell Death (PD)-1) after allogeneic HSCT.

- Received or planned to receive anti-Cluster of Differentiation (CD) 20 B-cell targeted
therapy (e.g., rituximab) after allogeneic HSCT.

- Non-study pneumococcal vaccine administered after allogeneic HSCT, or is expected to
receive non-study pneumococcal vaccine during participation in the study.

- Is currently participating or has participated in an interventional clinical study
with an investigational compound/agent or device within 2 weeks of participating in
this current study, or plans to receive any investigational compound/agent or device
(in addition to existing therapy) within 2 weeks of any vaccination, that in the
opinion of the investigator would interfere with the evaluation of the study
objectives.

- Is, at the time of signing informed consent, a user of recreational or illicit drugs
or has had a recent history (within the last year) of drug or alcohol abuse or
dependence as assessed by the study investigator.

- Has history or current evidence of any condition, therapy, laboratory test result
abnormality, or other circumstance that might expose the participant to risk by
participating in the study, confound the results of the study, or interfere with the
participant's participation for the full duration of the study.

- Is or has an immediate family member who is investigational site or Sponsor staff
directly involved with this study.
We found this trial at
8
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-803-7468
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-834-4430
University of Chicago One of the world's premier academic and research institutions, the University of...
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Gainesville, Florida 32610
(352) 392-3261
Phone: 352-265-0111
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-1878
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Darlinghurst, New South Wales 2010
Phone: +61293555611
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Indianapolis, Indiana 46237
Phone: 317-528-7298
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-3894
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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211 Quarry Road
Palo Alto, California 94305
Phone: 650-723-7362
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