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

Completed · Phase 3

Conditions studied: Pneumococcal Infections

In brief

The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant \[allo-HSCT\] in participants who do not develop chronic graft-versus-host disease \[GVHD\]).

Key facts

Study ID

NCT03565900

Run by

Merck Sharp & Dohme LLC

People needed

277

Starts

2018-09-12

Expected to finish

2021-11-04

Last updated by the study team

2023-07-28

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) >6 × 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.

Where it is running

• Children's Hospital Colorado ( Site 0166) — Aurora, Colorado, United States
• University of Florida ( Site 0011) — Gainesville, Florida, United States
• University of Chicago ( Site 0016) — Chicago, Illinois, United States
• Indiana Blood and Marrow Transplantation ( Site 0001) — Indianapolis, Indiana, United States
• University of Kansas Medical Center ( Site 0007) — Kansas City, Kansas, United States
• Johns Hopkins - University ( Site 0023) — Baltimore, Maryland, United States
• Children's Mercy Hospital ( Site 0167) — Kansas City, Missouri, United States
• Montefiore Einstein Center ( Site 0164) — The Bronx, New York, United States
• Cincinnati Children's Hospital Medical Center ( Site 0010) — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation ( Site 0168) — Cleveland, Ohio, United States
• Oregon Health & Science University ( Site 0018) — Portland, Oregon, United States
• Baylor College of Medicine - Texas Children's Hospital ( Site 0165) — Houston, Texas, United States
• St. Vincent's Hospital ( Site 0041) — Sydney, New South Wales, Australia
• The Children s Hospital at Westmead ( Site 0191) — Westmead, New South Wales, Australia
• Royal Adelaide Hospital ( Site 0040) — Adelaide, South Australia, Australia
• Austin Health-Austin Hospital ( Site 0038) — Heidelberg, Victoria, Australia
• The Alfred Hospital ( Site 0037) — Melbourne, Victoria, Australia
• Royal Melbourne Hospital ( Site 0039) — Parkville, Victoria, Australia
• Cliniques Universitaires Saint-Luc ( Site 0122) — Brussels, Bruxelles-Capitale, Region de, Belgium
• UZ Leuven ( Site 0119) — Leuven, Vlaams-Brabant, Belgium
• AZ Sint Jan Brugge-Oostende ( Site 0118) — Bruges, West-Vlaanderen, Belgium
• AZ Delta ( Site 0120) — Roeselare, West-Vlaanderen, Belgium
• Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121) — Liège, Belgium
• Hospital Sao Rafael ( Site 0049) — Salvador, Estado de Bahia, Brazil
• Stanford Health Care ( Site 0005) — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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