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Vaccines

HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Medical Monitor

To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.

An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)

An Open-Label, Single-Dose, Safety and Tolerability Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 26 Years

All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection

Merck Sharp & Dohme LLC

18 to 26 years of age group was enrolled to evaluate safety firstly.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

18 to 26 Years of Age Group

9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

9 to 17 Years of Age Group

Total

Age, Continuous

Sex: Female, Male

Body Temperature

Pulse

Senior Vice President, Global Clinical Development

Serious Adverse Experiences

Systemic Adverse Experiences

Injection-Site Complaints

Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination

Overall Study

Neoplasms

Carcinoma

Immunologic Factors

Participants 9-14 years old receive Cervarix IM at baseline.

Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.

Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine

Recombinant Human Papillomavirus Bivalent Vaccine

Aimee R Kreimer

This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV) infection. Cervarix is a vaccine used to prevent cervical cancer caused by HPV types 16 and 18. Gardasil is vaccine used to prevent cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. Giving only one dose of the Cervarix vaccine in girls may work the same as 3 doses of the Gardasil vaccine in young women in preventing HPV infection and ultimately, cervical and other HPV-related cancers. Currently, many women around the world cannot get HPV vaccines because they are too expensive. If this trial can show one dose given to young girls is enough to prevent cancer, more girls might be able to get the vaccine.

PRIMARY OBJECTIVE:

I. To demonstrate that the immunogenicity (as determined by enzyme-linked immunosorbent assay \[ELISA\]) of a single dose of recombinant human papillomavirus bivalent vaccine (Cervarix) in 9-14 year old girls is non-inferior to the immunogenicity of three doses of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil), administered at 0, 2, and 6 months, in 18-25 year old women 36 months after initial vaccination, with an interim analysis at 24 months after initial vaccination.

SECONDARY OBJECTIVES:

I. To compare the distribution of HPV -16 and HPV-18 antibodies levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

II. To compare rates of seroconversion based on HPV-16 and HPV-18 antibody levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women.

III. To compare geometric mean titers (GMTs), distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-11 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women; to perform a similar comparison restricting to 12-14 year old girls.

IV. To compare GMTs, distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 1-month after vaccination and 1-year after vaccination, following a single dose of Cervarix in 9-10 year old girls and a single dose of Cervarix in 11-14 year old girls.

V. To evaluate whether baseline variables (e.g. geographic district, initial antibody levels, date of vaccination) are associated with GMTs, distributions, and seroconversion rates for HPV16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants 9-14 years old receive Cervarix intramuscularly (IM) at baseline.

GROUP II: Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.

After completion of trial vaccine dose(s), participants are followed up at 1, 12, 24, and 36 months.

Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial

Non-Inferiority Trial Comparing Immunogenicity From 1-Dose of Bivalent HPV Vaccine in Girls to 3-Doses of Quadrivalent Vaccine in Women: The PRIMAVERA-ESCUDDO Trial ("Puente de Respuesta Inmunológica Para Mejorar el Acceso a Vacunas y ERrAdicar el Cancer")

Will measure HPV-16 specific serum antibody using the HPV type-specific enzyme-linked immunoassay (ELISA) on serum. Will estimate the two-sided 99% confidence interval of the geometric mean titer (GMT) ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

Will measure HPV-16 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months.

National Cancer Institute (NCI)

Immune System Diseases

Digestive System Diseases

Rare Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Papilloma

HIV Seropositivity

Precancerous Conditions

Anus Neoplasms

Penile Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Penile Diseases

Male Urogenital Diseases

Penile Cancer

Anal Cancer

Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

laboratory biomarker analysis

Joel Palefsky, MD

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection.

PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.

OBJECTIVES:

Primary

* To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing penile/scrotal condyloma and HPV-6, -11, -16, -18- associated perianal/anal disease in HIV-positive males who have sex with males (MSM) age 13-26 years by comparing the incidence of these lesions among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
* To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing persistent anogenital infection with HPV-6, -11, -16, or 18 in HIV-positive MSM age 13-26 years by comparing the incidence of persistent infection among those naïve to the relevant HPV type(s) at baseline to those who are not naïve at baseline.
* To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing anogenital lesions associated with HPV 6,-11,-16, -18 and persistent infection with these types, in HIV-positive MSM age 13-26 years by comparing the incidence of lesions and persistent infection among those naïve to the relevant types at baseline to incident lesions and infection among MSM naïve to these HPV types who participated in the Merck 020 protocol and who received placebo as part of the protocol.

Secondary

* To define the safety of the HPV-6, -11, -16, -18 vaccine in HIV-positive MSM age 13-26 years.
* To evaluate the levels and persistence of HPV 6, 11, 16 and 18 Ab titers after the vaccination series among subjects who are seropositive and seronegative at baseline.
* To examine whether the protective effect and antibody titers vary as a function of the following at the time of initial vaccination: subject age, HAART treatment status, HIV viral load, CD4 + T-cell count, and nadir CD4 level.

Tertiary

* To quantify anogenital HPV DNA viral load prior to and after receipt of the quadrivalent HPV vaccine.
* To identify and quantify HPV types in the oral cavity of HIV-positive MSM prior to and after receipt of the quadrivalent HPV vaccine.
* To identify HPV strain variants among HIV-positive participants prior to and after receipt of the quadrivalent HPV vaccine.
* Assess the prevalence and incidence of urinary and gonorrhea and Chlamydia trachomatis infection at baseline and their relationship with prevalent and incident anogenital HPV infection and anal condyloma or AIN.
* To characterize young men's risk perceptions, sexual behaviors, and STI diagnosis after HPV vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine intramuscularly on day 1 and in weeks 8 and 24.

Blood and tissue samples may be collected periodically for laboratory studies.

After completion of study treatment, patients are followed up for 2 years.

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.

Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.

Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.

Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.

Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site.

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline.

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline.

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline.

Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.

Geometric mean concentration of antibodies for HPV 6 at each visit

Geometric mean concentration of antibodies for HPV 11 at each visit

Geometric mean concentration of antibodies for HPV 16 at each visit

Geometric mean concentration of antibodies for HPV 18 at each visit

Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months

Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months

Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months

Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months

The Emmes Company, LLC

University of Arkansas

AIDS and Cancer Specimen Resource

AIDS Malignancy Consortium

All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.

Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

laboratory biomarker analysis

Vaccination

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Puerto Rico

United States

Region of Enrollment

Eligible participants who received at least one dose of vaccine.

Dr. Joel M. Palefsky

This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.

HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Naive to HPV 6

HPV 6 positive based on serum at visit 0.

Prior Exposure to HPV 6

Eligible participants without prevalent HPV 6 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA

This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.

HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Naive to HPV 11

HPV 11 positive based on serum at visit 0.

Prior Exposure to HPV 11

Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA

This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.

HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Naive to HPV 16

HPV 16 positive based on serum at visit 0.

Prior Exposure to HPV 16

Eligible participants without prevalent HPV 16 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA

This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.

HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Naive to HPV 18

HPV 18 positive based on serum at visit 0.

Prior Exposure to HPV 18

Eligible participants without prevalent HPV 18 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA

This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.

HPV 6 positive based on serum at visit 0 from any anatomical site.

Prior Exposure HPV 6

All eligible participants who were HPV 6 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Incidence of Persistent Anogenital Infection With HPV 6 DNA

This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.

HPV 11 positive based on serum at visit 0 from any anatomical site.

All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Incidence of Persistent Anogenital Infection With HPV 11 DNA

This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.

HPV 16 positive based on serum at visit 0 from any anatomical site.

All eligible participants who were HPV 16 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Incidence of Persistent Anogenital Infection With HPV 16 DNA

This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.

HPV 18 positive based on serum at visit 0 from any anatomical site.

All eligible participants who were HPV 18 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

Incidence of Persistent Anogenital Infection With HPV 18 DNA

Eligible participants without prevalent HPV 6 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of HGAIN Associated With HPV 6

Eligible participants without prevalent HPV 11 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of HGAIN Associated With HPV 11

Eligible participants without prevalent HPV 16 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of HGAIN Associated With HPV 16

Eligible participants without prevalent HPV 18 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Incidence of HGAIN Associated With HPV 18

Eligible participants without penile/scrotal condyloma at baseline who received at least one vaccination and returned after month 7 with evaluable clinical assessments.

Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants

Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants

Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants

Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants

The safety population included eligible participants who received at least one vaccination.

Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine

Baseline

Month 7

Month 12

Month 18

Month 24

HPV 6 Sero-negative at Baseline

HPV 6 Sero-positive at Baseline

Eligible participants who received at least one vaccination with evaluable serum assessments.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)	NCT00635830	HPV Infections	Quadrivalent Hu...	9 Years - 26 Years	Merck Sharp & Dohme LLC
Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial	NCT03728881	Human Papilloma...	Quadrivalent Hu... Recombinant Hum...	9 Years - 25 Years	National Cancer Institute (NCI)
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males	NCT01209325	Anal Cancer Nonneoplastic C... Penile Cancer Precancerous Co...	quadrivalent hu... laboratory biom...	13 Years - 26 Years	AIDS Malignancy Consortium
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)	NCT00090220	Healthy Adult F... Prevention Papillomavirus ... Human Papilloma...	Quadrivalent Hu... Comparator: Pla...	24 Years - 45 Years	Merck Sharp & Dohme LLC
Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)	NCT00733122	HPV Infections	Quadrivalent Hu...	16 Years - 26 Years	Merck Sharp & Dohme LLC
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)	NCT00380367	Papillomavirus ...	Quadrivalent Hu...	9 Years - 15 Years	Merck Sharp & Dohme LLC
Tolerability and Immunogenicity of Gardasil in Females Between 16 and 23 Years of Age in India (V501-034)	NCT00733122	HPV Infections	Quadrivalent Hu...	16 Years - 26 Years	Merck Sharp & Dohme LLC
Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial	NCT03728881	Human Papilloma...	Quadrivalent Hu... Recombinant Hum...	9 Years - 25 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine