Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
Condition: Transplant-Related Cancer
Intervention: Havrix; PCV13
Intervention description: 1440 ELISA units, or 1 mL, IM; 0.5 mL IM
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Only the study pharmacist was unblinded.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research is being done to understand the effects of certain types of bone marrow
      transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your
      family members as the bone marrow donor, for your cancer. Part of that BMT involves a
      chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This
      research is being done to understand the effects of Cyclophosphamide on the immune system.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients inclusion for study:

          1. Patient age > 18 years.

          2. Plan to undergo one of the following types of transplant, using bone marrow from a
             related donor:

               -  Myeloablative, HLA matched or partially HLA-mismatched (haploidentical),
                  related-donor bone marrow transplantation that includes high-dose
                  posttransplantation Cy

               -  Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone
                  marrow transplantation that includes high-dose posttransplantation Cy Note:
                  Patients who receive posttransplantation rituximab are eligible.

        Patients inclusion for vaccine:

          1. Receipt of the type of myeloablative or nonmyeloablative BMT

          2. The bone marrow donor has received the pre-bone marrow harvest vaccine (either Prevnar
             or hepatitis A vaccine) on this study.

        Donors inclusion:

        1. Donor age > 18 years.

        Exclusion Criteria:

        Patients exclusion for study entry:

          1. Hypersensitivity to either the components of hepatitis A vaccine (including neomycin)
             or the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).

          2. Severe latex allergy.

        Patients exclusion for vaccine:

          1. Graft failure.

          2. Disease progression or relapse, or disease persistence requiring treatment.Note:
             Patients with asymptomatic or low-volume disease progression or relapse may be
             eligible, determined on a case-by-case basis by the PI.

          3. Systemic immunosuppression for GVHD treatment or prophylaxis within 4 weeks (+/- 5
             days) prior to vaccination.

          4. Pregnant or breastfeeding

        Donors exclusion:

          1. Hypersensitivity to both the components of hepatitis A vaccine (including neomycin)
             and the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).

          2. Severe latex allergy.

          3. Expected to be on systemic immunosuppressants between the time of vaccination and the
             bone marrow donation.

          4. Pregnant or breastfeeding