Higher Infused Lymphocyte Counts Improve Antibody Response to Immunization After Autologous Stem Cell Transplantation

Infectious diseases remain a leading cause of morbidity and mortality in patients who receive
high-dose chemotherapy followed by Autologous Peripheral Blood Stem Cell Transplantation
(APBSCT). Infectious disease complications of transplantation might be reduced by effective
post-transplant immunization but reconstitution of the immune system may take months to years
after transplantation and responses to immunization are often attenuated in this setting.
Correlates of improved immune reconstitution and response to immunization after
transplantation would be important to identify. It has been recently shown that higher
absolute lymphocyte count in the infused stem cell autograft (A-ALC) and higher ALC at day
+15 after stem cell infusion (ALC-15) are independently associated with improved overall
survival after APBSCT. The mechanism of this association is unclear, but this finding
suggests that improved immune responses to immunization might also be achieved with this
approach making it possible to immunize at 6 months instead of at one year. This hypothesis
has never been evaluated.

Survival following APBSCT is improved with a higher A-ALC and ALC-15. It is postulated that
the higher lymphocyte numbers correlate with improved immune surveillance and destruction of
minimal residual disease. Thus, one must consider the probability higher A-ALC will confer
improved response to T-cell dependent immunization early after transplant.

Inclusion Criteria:

- 18 years of age or older

- Lymphoma or lymphoproliferative disease diagnosis

- Scheduled APBSCT

- Able to give informed consent and comply with the procedures of the study

- Enrollment in other interventional trials are allowed at the discretion of the
investigators

Exclusion Criteria:

- Contraindication to Prevnar®

- Has received immune globulin within 5 months prior to being enrolled on the study or
plans to receive immune globulin prior to the day +270 (+/-30) visit

- Currently participating in, or scheduled to participate in any clinical trial using
investigational immune modulators (e.g. IL-2) at any time prior to the completion of
follow-up in this study.

- Any other underlying medical condition that, in the opinion of the investigator, may
interfere with the evaluation of study objectives

- Day +180(+/- 30days) Eligibility:

- Has received immune globulin within the past 5 months prior to the receipt of the
vaccine or plans to receive immune globulin prior to the day +270(+/- 30) visit

- Is pregnant (as determined by urine or serum B-HCG test)

- Participant has a contraindication to Prevnar®

- A recent (<72 hours) febrile illness (axillary temperature >99.5°F [>37.5°C], oral
temperature >100.3oF [>37.9oC], or rectal temperature >101.3°F[>38.5°C]) prior to the
study vaccination