Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.
The research will involve giving your donor a vaccine against a certain infection, before
the bone marrow donation: either a vaccine against hepatitis (the hepatitis A vaccine), or a
vaccine against pneumonia (Prevnar). You will then get both of these vaccines following
your transplant. By studying how much these vaccines may improve your immune system, we
hope to better understand the effects of the BMT with Cyclophosphamide on the immune cells.
Prevnar is a pneumococcal vaccine (pneumococcus is a bacteria that can cause pneumonia and
other infections). It is approved by the Food and Drug Administration (FDA) for the
prevention of infections in children. It is not usually given to adults. Hepatitis A
vaccine is approved by the FDA for the prevention of hepatitis A (a liver infection) in
children and adults.
The vaccines are not approved for bone marrow donors or for vaccinating adults after BMT
(using these vaccines in this research is investigational). The FDA is allowing the use of
these vaccines in this research study.
Certain people getting BMT followed by Cyclophosphamide may join, if their donors might also
join. Your bone marrow donor must take part in this study, in order for you to continue on
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether the vaccine-specific T cell immunity observed in the patient is augmented when the vaccine is also given to the bone marrow donor
Yvette Kasamon, M.D.
Johns Hopkins University
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center||Lutherville, Maryland|