Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Transplant-Related Cancer

Treatments: Biological: PCV13; Biological: Havrix

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01282216

NA_00044665 (Other Identifier)

P01CA015396 (U.S. NIH Grant/Contract)

J10140

Details and patient eligibility

About

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.

Full description

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 this study

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Donor PCV13

Active Comparator group

Description:

Donors receive PCV13 prior to bone marrow donation.

Treatment:

Biological: PCV13

Donor Havrix

Active Comparator group

Description:

Donors receive Havrix prior to bone marrow donation.

Treatment:

Biological: Havrix

Recipient vaccine

Active Comparator group

Description:

Recipients receive Havrix and PCV13 post bone marrow transplant.

Treatment:

Biological: PCV13

Biological: Havrix