Neoplasms

All Conditions

Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Vaccines

Immunologic Factors

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.

9-valent HPV vaccine, 2 dose efficacy

Will be comparison group for 2 dose efficacy group.

9-valent HPV vaccine, 3 doses standard timing

Abbey B Berenson, MD, PhD

We are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.

The investigators are studying an amended dosing regimen of an approved drug (Gardasil 9) in the population for which it is approved (vaccine is approved for ages 9-45 years and participants in this study will be 15-26 years of age.) The purpose of the study is to examine a delayed dosing schedule. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-26 years of age but only 2 doses (0 and 6 months) if given at 9-14 years of age. The investigators will conduct a randomized study to determine if 2 doses will elicit an immune response similar to the standard 3 doses in those 15-26 years of age. Participants in the study group will receive 2 doses of Gardasil 9 at 0 and 6 months. Participants in the control group will receive 3 doses of Gardasil 9 at 0, 1-2 months and 6 months. All participants (Target Accrual n=512) will have 5 mLs of blood drawn at 0, 7, and 12 months. Following the 12 month blood draw, participants randomized to 2-doses will receive the 3rd dose. Potential participants will be recruited in the University of Texas Medical Branch (UTMB) clinics where providers have given the PI permission to directly contact patients. The investigators will also display signs and use email announcements at UTMB and other college campuses and will advertise the study online or by mail. The investigators will call UTMB patients if their provider gave permission to contact the patient, or if the patients gave prior consent to contact through the UTMB system. Potential participants (and their parents, if under 18 years of age) will be screened with inclusion/exclusion criteria. Eligible and interested parents and patients will sign informed written consent. Patients under 18 years of age will sign written assent. At the initial visit, eligible, consented participants will have their blood drawn, be randomized into either the study or control group, and receive a dose of the HPV vaccine. Participants will be re-screened against the inclusion/exclusion criteria at subsequent visits. All participants will receive compensation administered through a ClinCard following each of the 3 blood draws.

Vials submitted for assay will be de-identified and labeled only with the study ID number.

GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 6. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 11. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 16. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 18. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 31. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 33. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 45. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 52. Measured as number of participants.

Yes/ No count, Number of patients with an antibody level at or above predetermined cutoff (natural immunity) for HPV type 58. Measured as number of participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose	NCT03943875	Immunization Efficacy Human Papilloma...	9-valent HPV va... 9-valent HPV va...	15 Years - 26 Years	The University of Texas Medical Branch, Galveston
GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose	NCT03943875	Immunization Efficacy Human Papilloma...	9-valent HPV va... 9-valent HPV va...	15 Years - 26 Years	The University of Texas Medical Branch, Galveston

Spots Global Cancer Trial Database for vaccine efficacy