Infections

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Rare Diseases

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Papillomavirus Infections

Disease Attributes

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Sexually Transmitted Diseases, Viral

Virus Diseases

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Oculocerebral Syndrome With Hypopigmentation

All Drugs and Chemicals

Vaccines

Immunologic Factors

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)

laboratory biomarker analysis

survey administration

medical chart review

Wendy Landier, PhD, CRNP

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.

PRIMARY OBJECTIVES:

I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.

II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.

III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.

OUTLINE:

AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.

AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years

To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.

To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.

National Cancer Institute (NCI)

Merck Sharp & Dohme LLC

University of Alabama at Birmingham

Principal Investigator

No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm.

Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Prevention (Vaccine Therapy)- Quadrivalent

Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Prevention (Vaccine Therapy)- Nonavalent Vaccine

Prevention (Vaccine Therapy)

Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.

Survey

Total

9-15 years

16-26 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Wendy Landier, Deputy Director, Institute for Cancer Outcomes and Survivorship

Participants who consented to the survey aim of the study.

Survey Participants

Participants who returned an evaluable survey

Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])

Historical Healthy Population Reference:

QUADRIVALENT

Male and female, all age groups:

Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)

GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)

Historical Healthy Population Reference:

NONAVALENT

Girls 9-15, Boys 9-15, Women 16-26:

Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;

Historical Healthy Population Reference:

NONAVALENT

Men 16-26:

Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data).

Quadrivalent Anti-HPV 16, Male, Age 9-15 Years

Quadrivalent Anti-HPV 16, Female, Age 9-15 Years

Quadrivalent Anti-HPV 16, Male, Age 16-26 Years

Quadrivalent Anti-HPV 16, Female, Age 16-26 Years

Nonavalent Anti-HPV 16, Male, Age 9-15 Years

Nonavalent Anti-HPV 16, Female, Age 9-15 Years

Nonavalent Anti-HPV 16, Male, Age 16-26 Years

Nonavalent Anti-HPV 16, Female, Age 16-26 Years

Quadrivalent Anti-HPV 18, Male, Age 9-15 Years

Quadrivalent Anti-HPV 18, Female, Age 9-15 Years

Quadrivalent Anti-HPV 18, Male, Age 16-26 Years

Quadrivalent Anti-HPV 18, Female, Age 16-26 Years

Nonavalent Anti-HPV 18, Male, Age 9-15 Years

Nonavalent Anti-HPV 18, Female, Age 9-15 Years

Nonavalent Anti-HPV 18, Male, Age 16-26 Years

Nonavalent Anti-HPV 18, Female, Age 16-26 Years

Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])

Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6

Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6

Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6

Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5

Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5

Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5

Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5

Injection site - Pain, any

Injection site - Swelling, any

Injection site - Erythema, any

Systemic - Headache

Systemic - Fever

Systemic - Nausea

Systemic - Dizziness

Systemic - Fatigue

Nonavalent Vaccine

Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.

Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

laboratory biomarker analysis: Correlative studies

survey administration: Ancillary studies

medical chart review: Ancillary studies

Spots Global Cancer Trial Database for prevention of human papillomavirus infection