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HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)

The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old.

Gardasil9

Natalie Pierre-Joseph, MD

Johane Seide, MBA

This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. The investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (Month 13) and at Month 60.

Though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (HPV), this descriptive study will allow the investigators to understand whether the 9vHPV vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vHPV vaccine.13 This study will require an IND for the use of the HPV vaccine in children younger than 9 years.

Immunogenicity will be measured by examining serum antibodies of all participants using a competitive Luminex immunoassay (cLIA).15 Month 60 serology will be by cLIA and IgG LIA assays. The antibody response testing will be performed at Merck Research Laboratory.

The goal of this study is to explore whether a 2-dose 9vHPV vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. The primary outcome will be geometric mean titers (GMT) for HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 antibodies at months 13 and 60. Results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vHPV recipients vaccinated at ages 9-14.13 Knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers through 4 years after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vHPV regimen for children aged 4-8 years.

Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study

An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is \>30mMu.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is \>16mMu.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is \>20mMu.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is \>24 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is \>10 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is \>8 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is \>8 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is \>8 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is \>8 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is \>30mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is \>16 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is \>20 mMU.

A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is \>24mMU.

Solicited local swelling will be graded from 0-4 where 0 is no swelling and 4 is severe swelling.

Solicited local redness will be graded from 0-4 where 0 is no redness and 4 is severe redness.

Merck Sharp & Dohme LLC

Boston Medical Center

Doctor

Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

Postpartum HPV Vaccination

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

This was established using a survey to indicate willingness to receive vaccine.

Those that actually received the vaccine and each time point.

University of Alabama at Birmingham

Professor

Age, Continuous

Female only

Sex/Gender, Customized

White

Black

Hispanic/Latino

Race/Ethnicity, Customized

Haller Smith

Patient Indication of Willingness to Accept the Vaccine Based on Survey

1 participant consented to vaccine and then subsequently withdrew

Uptake of the Vaccine Doses

1 patient consented to vaccine and then withdrew

36 patients received the 2nd vaccine dose

Serum Titers of Vaccine-specific HPV Types

First Vaccine

Second Vaccine

Third Vaccine

Final Questionnaire and Blood Draw

Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Jenell Coleman, MD

Chailee Moss, MD

Betty Chou, MD

The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.

This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.

Women seeking postpartum care at Johns Hopkins University who self-report never receiving an HPV vaccination.

HPV Vaccination Study in Postpartum Women

A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV

Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.

The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58.

The milli Merck units (mMU)/mL of measure will be used to determine antibody response.

Calculate the percentage of participants that seroconverted.

Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.

Calculate the amount of participants that complete 2-dose vaccination.

Johns Hopkins University

Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Sex: Female, Male

Race/Ethnicity

United States

Region of Enrollment

Highest level of education

Employed

Dr. Jenell Coleman

We excluded participants whose anti-HPV 16 titer was above the seroconversion limit and the baseline. Therefore, only 129 were included in this analysis

Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer

During analysis, we exclude participants who had antibodies titers above the seroconversion limit at the baseline for each HPV subtype seperately. Therefore, the number of participants analyzed are smaller than 225.

Antibody Response to the Other 8 HPV Types

There were some participants seroconverted at the baseline so were excluded from the analysis for each type of HPV.

Seropositivity for HPV 16 After 1-dose

Participants with anti-HPV 16 titer above the seropositivity threshold were excluded in this analysis. This is analysis among participants who received the second dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study	NCT05329961	Human Papilloma...	Gardasil9	4 Years - 8 Years	Boston Medical Center
Postpartum HPV Vaccination	NCT03451071	HPV-Related Mal...	Gardasil9	16 Years - 26 Years	University of Alabama at Birmingham
Postpartum HPV Vaccination	NCT03451071	HPV-Related Mal...	Gardasil9	16 Years - 26 Years	University of Alabama at Birmingham
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study	NCT05329961	Human Papilloma...	Gardasil9	4 Years - 8 Years	Boston Medical Center
HPV Vaccination Study in Postpartum Women	NCT04274153	HPV Immunization Human Papilloma...	Gardasil9	15 Years - 45 Years	Johns Hopkins University

Spots Global Cancer Trial Database for gardasil9

Every month we try and update this database with for gardasil9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gardasil9

Every month we try and update this database with for gardasil9 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gardasil9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.