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V114-022

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
V114-0222018-000066-11

A Phase 3, Randomized, Double-Blind, Active-Comparator-Controlled, Multicenter Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Reci-pients of Allogeneic Hematopoietic Stem Cell Transplant

Status: Active

Purpose / Objectives

Primary Outcome

  • To evaluate the safety and tolerability of 3 doses of V114 and 3 doses of Prevnar 13™ with respect to the proportion of participants with adverse events (AEs) within each vaccination Group.
  • To evaluate the serotype-specific immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the 3rd dose of V114 and following the 3rd dose of Prevnar 13™within each vaccination Group.

 

 

Secondary Outcomes

  • To evaluate the safety and tolerability of PNEUMOVAX™23 (administered 12 months after allo-HSCT) following 3 doses of V114 and following 3 doses of Prevnar 13™) with respect to the proportion of participants with AEs within each vaccination Group.
  • To evaluate the safety and tolerability of a 4th dose of V114 and a 4th dose of Prevnar 13™ (both administered 12 months after allo-HSCT) with respect to the proportion of participants with AEs within each vaccination group
  • To evaluate the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days following the 3rd dose of V114 and following the 3rd dose of Prevnar 13™ within each vaccination Group.
  • To evaluate the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days following the 3rd dose of V114 and following the 3rd dose of Prevnar 13™ within each vaccination Group.

 

 

 

 

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  1. Received a human leukocyte antigen (HLA) compatible donor including haploidentical and mismatched (related or unrelated) first allo-HSCT (ie, bone marrow or peripheral blood stem cell) 90 to 180 days prior to randomization (Visit 2).
  2. Received the allo-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, aplastic anemia, or sickle cell disease.
  3. Life expectancy >12 months after allo-HSCT, according to investigator judgement.
  4. Clinically stable engraftment according to investigator judgment.
  5. [...]

Exclusion criteria

  1. Receipt of a previous allo-HSCT.
    Note: recipients of a previous autologous HSCT are eligible.
  2. Received allo-HSCT with ex-vivo graft manipulation (e.g. CD34 selection, TCR Alpha beta depletion, etc), in vivo T cell depletion with alemtuzumab, or haploidentical allo- HSCT with high dose anti-thymocyte globulin.
  3. Received allo-HSCT for:
    Multiple myeloma
    Any nonmalignant diseases
  4. Exception: participants with sickle cell disease and aplastic anemia are eligible
  5. Persistent or relapsed primary disease (diagnosed as per the investigator’s institution’s morphologic criteria for refractory or relapse of disease) after allo-HSCT.
  6. History of severe GVHD (Grade 3 or 4 GVHD) after allo-HSCT
    Note: determined as per GVHD grading scale used by investigator institution.
  7. Planned organ transplantation after allo-HSCT.
  8. History of culture-positive pneumococcal disease occurring after allo-HSCT (eg, positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site).

[…]
22. Non-study pneumococcal vaccine administered after allo-HSCT, or is expected to receive non-study pneumococcal vaccine during participation in the study.

23. *Received any licensed, non-live vaccine within 14 days before receipt of any study vaccine, or is scheduled to receive any licensed, non-live vaccine within 14 days after receipt of any study vaccine.

Exception: inactivated influenza vaccine and haemophilus influenzae type B (Hib) vaccine may be administered, but only if it is administered at least 7 days before receipt of any study vaccine and/or at least 7 days after receipt of any study vaccine.

24. *Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days after receipt of any study vaccine.

25. 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

Trial design

  • Phase III
  • Multicenter
  • Randomized
  • Two-arm
  • Double-blind

Intervention

V114 or Prevnar 13™ will be administered at Visit 2 (Day 1), Visit 3 (Day 30), and Visit 4 (Day 60).

PNEUMOVAX™23, or alternatively V114 or Prevnar 13™ for participants with chronic GVHD, will be administered at Visit 6 (12 months after allo-HSCT).

 

Documents (password protected)

Responsibilities in overall trial

MSD Sharp & Dohme GMBH

National Coordinating Investigator

PD Dr. med. Guido Kobbe

Study Sites

Klinik I für Innere Medizin

Study office

Status

Active

Principal Investigator

Univ.-Prof. Dr. med. Oliver A. Cornely

Deputy of Principal Investigator

  • Dr. med. Sibylle Christiane Mellinghoff

Subinvestigator

  • Dr. med. Lena M. Biehl
  • Dr. med. Philipp Köhler
  • Dr. med. Annika Claßen (geb. Löhnert)
  • Marta Rebeca Cruz Aguilar
  • Dr. med. Lukas Frenzel
  • PD Dr. Dr. med. Udo Holtick
  • PD Dr. med. Marco Herling
  • Jannik Stemler
  • Maximilian Schons

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