Trial Information

Immunogenicity Of A Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, And 18) L1 Virus-Like Particle Vaccine In Male And Female Adolescent Transplant Recipients.

Currently Merck manufactures the HPV (types 6, 11, 16, and 18) L1 virus like particle
vaccine and a description has been reported previously. (18) Merck will supply the vaccine,
which will be stored as directed by the manufacturer. The vaccine will be stored at the
Medstar Research Institute (Women and Infants Research Services) It will be administered by
intramuscular injection (0.5 mL) into the upper arm or thigh by the research nurse (Sarah
Duwel, RN or a nurse working under supervision) in the transplant clinic.

Participants will be given a form to fill out regarding allergic prior to vaccination. After
the research nurse reviews the form with the patient and their guardian, an immunization or
blood collection will be performed. Participants will receive a full dose vaccine on day 1,
at month 2 (± 3 weeks), and at month 6 (± 3 weeks). All participants will be required to be
afebrile (oral temperature <37.8° C) within 24 hours before each injection.

All female participants will undergo urine pregnancy testing and will not be vaccinated if
found to be pregnant. Female participants with a positive urine pregnancy test will be
informed confidentially of their test results by the study nurse and will be referred to an
OB/GYN for further care.

Serum samples will be obtained from all participants on day 1, at month 3, and at month 7.
Samples will be de-identified and stored at -20°C or below and anti-HPV levels will be
determined using an HPV type-specific competitive Luminex xMAP-based immunoassay (cLIA).
(18) Merck will make arrangements for the labs tests. This assay measures only neutralizing
anti-HPV antibodies, rather than the broad assortment of vaccine-induced anti-HPV
antibodies. Antibody levels will be expressed as milliMerck units (mMU) per milliliter. The
lower limits of detection for the anti-HPV 6, 11, 16, and 18 cLIAs are 4.1 mMU6/mL, 3.0
mMU11/mL, 10.2 mMU16/mL, and 2.9 mMU18/mL, respectively. Assay precision is estimated to be
21.7%, 20.4%, 23.0%, and 15.9% for the anti-HPV 6, 11, 16, and 18 cLIAs respectively.
Participants will be considered anti-HPV 6, 11, 16, or 18 seropositive when their anti-HPV
antibody titers are 20 mMU6/mL, 16 mMU11/mL, 20 mMU16/mL, or 24 mMU18/mL, respectively.

Blood collection supplies will be obtained from a lab vendor Laprepco (www.labrepco.com).
The lab we will use to process our antibody titers is PPD Labs (www.ppdi.com). De-identified
blood samples will be stored by the research nurse at Mesdstar Research Institute until they
are able to be shipped to the PPD lab. Our research nurses are trained in Environmental and
Health Safety training based on Medstar Research Institution requirements. Antibody titers
results will be mail directly to Dr. Gomez-Lobo.