Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Status: | Completed |
---|---|
Conditions: | Vaccines |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 12/22/2018 |
Start Date: | January 18, 2010 |
End Date: | May 16, 2013 |
A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older
People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more
likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people
who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal
polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study
is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal
vaccine (13vPnC) followed by 23vPS.
likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people
who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal
polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study
is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal
vaccine (13vPnC) followed by 23vPS.
Inclusion Criteria:
- Male or female subject >=2 years of age.
- Allogeneic HSCT for hematologic disorder.
- Allogeneic HSCT with full myeloablative conditioning or reduced intensity
conditioning.
- Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment.
- Stable engraftment (absolute neutrophil count (ANC) >1000/µL; platelet count
>50,000/µL).
- Complete hematologic remission of underlying disease with very good partial remission
(VGPR) acceptable in the case of lymphoma and myeloma.
- Subject or parent/legal guardian expected to be available for the entire study and can
be contacted by telephone.
- Subject or parent/legal guardian must be able to complete an electronic diary
(e-diary) and complete all relevant study procedures during study participation.
- Hematological recovery as defined by ANC >1000/µL; platelet count >50,000/µL.
- All female and male subjects who are biologically capable of having children must
agree to abstinence or commit to the use of a reliable method of birth control from
signing of the ICF until for 3 months after the last vaccination.
- Negative urine pregnancy test for all female subjects of child bearing potential.
Exclusion Criteria:
- Autologous HSCT.
- Receipt of donor lymphocyte infusions during the 28 days preceding enrollment.
- Uncontrolled GVHD that in the opinion of the investigator would prevent the subject
from participating in the study.
- Lansky/Karnofsky Score <=60%.
- Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment.
- Receipt of rituximab since HSCT.
- Receipt of chemotherapy for relapse of underlying malignant disease since HSCT.
- Human immunodeficiency virus (HIV) infection.
- Lymphoproliferative disorder since HSCT.
- Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion
of the investigator would prevent the subject participating in the study.
- Vaccination with any licensed or experimental pneumococcal vaccine since HSCT.
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would in
the opinion of the investigator contraindicate intramuscular injection.
- Participation in another study with ongoing use of an unlicensed investigational
product from 28 days before study enrollment until the end of the study.
- Participation in another study with ongoing use of a licensed investigational product
that in the opinion of the investigator would interfere with the evaluation of the
study objectives.
- Permanent residence in a nursing home or other residential care facility.
- Pregnant or breastfeeding female subject.
- Subject who is a direct relative (child, grandchild, parent, or grandparent) of study
personnel, or is a member of the study personnel.
- Receipt of advanced therapy medicinal products (ATMP) including gene therapy products,
somatic cell therapy products, and tissue engineered products at any time before
enrollment.
- If information is available, - previous allergic or anaphylactic reaction to any
vaccine or vaccine-related component in a stem cell donor.
We found this trial at
10
sites
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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