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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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All Drugs and Chemicals

Vaccines

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-High formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Medium formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Low formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the marketed HPV vaccine on Day 1, Month 2, and Month 6.

3 doses of a high formulation investigational adjuvanted HPV9 vaccine intramuscularly (IM) on Day 1, Month 2, and Month 6.

HPV9 High formulation

3 doses of a medium formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.

HPV9 Medium formulation

3 doses of a low formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.

HPV9 Low formulation

3 doses of the marketed HPV vaccine (Gradasil 9) administered IM on Day 1, Month 2, and Month 6.

Gardasil 9

The Main purpose of this study is to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

Observer-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine

Only female participants, between 16-26 years of age are included in the study.

A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

A Phase 1/2 Randomized, Observer-blinded, Multi-country Study to Evaluate Safety and Immunogenicity of Investigational Adjuvanted Human Papillomavirus Vaccine in Females (16 to 26 Years of Age)

IPD for this study will be made available via the Clinical Study Data Request site.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in millimeters (mm) which is more than (\>) 50 mm.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in (mm) which is \>50 mm.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in mm which is \>50 mm.

Solicited systemic events include fever, headache, fatigue, myalgia, and arthralgia. Grade 3 fever is defined as temperature \>39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). Grade 3 headache, fatigue, myalgia and arthralgia are defined as severe events that prevent normal activity.

Solicited systemic events include fever, headache, fatigue, myalgia, and arthralgia. Grade 3 fever is defined as temperature \>39.0°C or 102.2°F. Grade 3 headache, fatigue, myalgia and arthralgia are defined as severe events that prevent normal activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/ Legally acceptable representative(s) (LAR(s)) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/ LAR(s) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, or other situations judged by the investigator as fitting the definition of a SAE.

Clinically relevant abnormalities for each biochemical and hematological parameter are defined as parameters outside the defined normal ranges for each parameter and are assessed after the first vaccine dose administered.

Solicited administration site events include pain, redness, and swelling.

Solicited systemic events include fever, headache, myalgia, arthralgia, and fatigue.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent.

pIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Seroconversion is defined as the appearance of antibodies (i.e., concentrations greater than or equal to the cut-off value) in the serum of participants seronegative before vaccination.

Seroconversion is defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of participants seronegative before vaccination.

Pearson coefficient is calculated for correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers.

GlaxoSmithKline

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Skin and Connective Tissue Diseases

Condylomata Acuminata

Warts

Papillomavirus Infections

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Immunomodulating Agents

Single-arm, open-label study. Intervention consists of intralesional injection of nonavalent human papillomavirus vaccine at 0 and 4 weeks.

Intralesional injection of nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks

nonavalent human papillomavirus vaccine

Ayan Kusari, MD

Kieron Leslie, MD

This study will investigate whether injecting genital warts with small quantities of the Gardasil 9 vaccine has an effect on the warts.

This is a prospective, open-label, proof-of-concept research study to assess the effectiveness of intralesional nonavalent in the treatment of patients with genital condylomata. The study will be conducted at Zuckerberg San Francisco General Hospital. The planned intervention is to provide 10 subjects with at least 3 genital condylomata with intralesional nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for change in wart size and wart number.

This is an open-label, single-arm study in which all participants will receive intralesional Gardasil 9 vaccine to their condyloma.

Intralesional HPV Vaccine for Condylomata

Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: an Open Label Pilot Study

Number of warts in genital area, as counted by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

Mean size of warts in genital area, as measured by study personnel at study visits. Genital area is defined as (1) suprapubic (2) left inguinal (3) right inguinal (4) vulvar (5) perineal (6) perianal in anatomic females, and as (1) suprapubic (2) left inguinal (3) right inguinal (4) dorsal penile (5) ventral penile and scrotal (6) perineal (7) perianal in anatomic males. Warts will be counted by study personnel at in-person evaluations at week 0, week 4 and week 12.

Established tool to measure quality of life with respect to condyloma. Will be administered at baseline and week 12 by study personnel. It comprises 10 items and 2 dimensions. The emotional dimension includes 6 items and the sexual activity dimension includes 4 items. The questions refer to the past 7 days. The higher the score the better the quality of life. The global scoring range was 10-50, ranging from 6 to 30 in the emotional dimensions and from 4 to 20 in the sexual activity dimension.

Established tool to measure quality of life with any dermatologic disease. Will be administered at baseline and week 12 by study personnel. Consists of 10 questions scored from 0-3. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

University of California, San Francisco

Disease Attributes

Immunologic Factors

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.

9-valent HPV vaccine, 2 doses alternate timing

This will be the comparison group for the 2-dose group.

9-valent HPV vaccine, 3 doses standard timing

Abbey B Berenson, MD, PhD

Rosalina M Trujillo

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

The investigators are studying an alternate dosing regimen of an approved drug (9vHPV vaccine) in the population for which it is approved. The vaccine is approved for individuals ages 9-45 years old and participants in this study will be 27-45 years of age. The purpose of the study is to examine the immune response of 2 doses of 9vHPV vaccine. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-45 years of age, but only 2 doses (administered at 0 and 6 months) if the vaccine series is initiated before age 15. The investigators will conduct a randomized study to determine if 2 doses of elicit a similar immune response to that of a standard 3 dose series in individuals 27-45 years of age. Participants in the study group will receive 2 doses of at 0 and 6 months. Participants in the control group will receive 3 doses of 9vHPV vaccine at 0, 2 months, and 6 months. All participants (target accrual n=618) will have 5 mLs of blood drawn at 0, 1, 7, and 12 months. Following the 12-month blood draw, participants randomized to 2-doses will be offered the 3rd dose. Potential participants will be recruited through the University of Texas Medical Branch (UTMB) clinics and surrounding community, and will be screened for inclusion/exclusion criteria. Eligible patients will sign an informed written consent. At their baseline visit, participants will have their blood drawn, be randomized into either the study or control group, and receive their first dose of the HPV vaccine. All participants will receive compensation administered through a ClinCard following each of the 4 blood draws.

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

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

Comparison of the Immune Response After Administration of 2 vs. 3 Doses of the FDA-approved 9-Valent HPV Vaccine Among Women 27-45 Years of Age

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.

Cancer Prevention Research Institute of Texas

The University of Texas Medical Branch, Galveston

Emergencies

Adults attending the Emergency Department who are aged 18-45, without previous HPV vaccination history and without previously known infection from HPV high-risk strain, and in good functional capacity.

Eligible participants will receive Gardasil 9 (HPV) vaccination if interested.

Prevent HPV-associated diseases and cancers

Andrzej Kulczycki, PhD

Lauren Walter, MD

Whitney Covington, MPH, MLS, (ASCP)CM

Patrick Siler, MD

Ruoyan Sun, PhD

To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).

Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department

All Study data and results will be owned by the University of Alabama at Birmingham (UAB). UAB agrees that all Study data and results generated during the course of the Study may be used fully by Merck for any legitimate business purpose without any additional payments being made to UAB or the PI. Merck agrees not to publish the research data and results generated during the Study until the PI's publication or presentation of the Study results in accordance with Article 9, or 18 months following study completion or termination of this Agreement, whichever occurs first. Merck may disclose the research data and results to health authorities if such disclosure is prior to publication. Merck shall use reasonable efforts to disclose such research data and results confidentially. UAB agrees not to provide any commercial third party with access to or with the right to use the unpublished data or results for any purpose without Merck's permission which shall not be unreasonably withheld.

HPV vaccination will be administered at the time of the study participant's initial visit (baseline)

Number of study participants receiving dose 2 of the HPV vaccination series 2 months after initial study visit

Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit

Merck Investigator Studies Program

University of Alabama at Birmingham

Associate Professor

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.

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.

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
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age	NCT05496231	Cervical Intrae...	HPV9 High formu... HPV9 Medium for... HPV9 Low formul... Gardasil 9	16 Years - 26 Years	GlaxoSmithKline
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
Intralesional HPV Vaccine for Condylomata	NCT05087849	Human Papilloma... Warts Warts, Genital Condyloma Condylomata Acu...	nonavalent huma...	18 Years -	University of California, San Francisco
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)	NCT05672927	Immunization HPV Infection Human Papilloma...	9-valent HPV va... 9-valent HPV va...	27 Years - 45 Years	The University of Texas Medical Branch, Galveston
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)	NCT05672927	Immunization HPV Infection Human Papilloma...	9-valent HPV va... 9-valent HPV va...	27 Years - 45 Years	The University of Texas Medical Branch, Galveston
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
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department	NCT06229353	Human Papilloma...	Gardasil 9	18 Years - 45 Years	University of Alabama at Birmingham
Intralesional HPV Vaccine for Condylomata	NCT05087849	Human Papilloma... Warts Warts, Genital Condyloma Condylomata Acu...	nonavalent huma...	18 Years -	University of California, San Francisco
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 gardasil 9

Every month we try and update this database with for gardasil 9 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 gardasil 9

Every month we try and update this database with for gardasil 9 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 gardasil 9 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.