Infections

All Conditions

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Communicable Diseases

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Vulvar Neoplasms

Papillomavirus Infections

Anus Neoplasms

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Escherichia coli Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

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Genital Diseases

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Disease Attributes

Vaginal Cancer

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All Drugs and Chemicals

Vaccines

0.5 mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

0.5-mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.

Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)

20-26 years possitive control group will be vaccinated at months 0, 2 and 6

GARDASIL® 9

Yongjiang Liu, Bachelor

The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.

This is a parallel-controlled study. A total of 2,750 participants will be enrolled in this study: 9-14 years (2 doses) group and 9-19 years (3 doses) group are of non-randomized, open label design; 20-26 years (3 doses) group will be randomized and blinded.

9-14 age group and group 9-19 age group will be enrolled in two stages: 20 subjects in 9-19 age group will be enrolled first. After assessing the safety data (including laboratory test data) within 7 days of 1st dose vaccination in these 20 subjects, and if the suspension criteria are not met, the remaining 620 subjects in 9-19 age group and 640 subjects in 9-14 age group will be enrolled subsequently. 20-26 age group will be enrolled directly, with no stage entry requirements. Eligible subjects will be enrolled to received vaccines accordingly. Subjects who have reached menarche will undergo urine pregnancy test prior to each dose of vaccination (on the vaccine day.)

A total of 2,750 participants were enrolled in this study: 9-14 years (2 doses) group was administrated with investigational vaccine on 0 Day, 6th month, and 9-19 years (3 doses) group was administrated with investigational vaccine on 0 Day, 2nd month and 6th month. Both of these two group are of non-randomized, open label design; 20-26 years (3 doses) group was randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control, respectivelyon 0 Day, 2nd month and 6th month.

The Sponsor, investigators and biostatisticians will remain blinded to subject allocation.

A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China

A Parallel-controlled Study to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in Healthy Female Participants Aged 9-26 Years in China

No informed consent was obtained to disclose the subject's data and sample test results

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group

GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.

SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.

GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.

SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.

First 20 subjects enrolled in 9-19 years group: abnormality rate of laboratory test on Day 3 after each dose of vaccination.

Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs within 30 minutes after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of SAE which within 72 months after first vaccination for all participants.

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of the occurrence of pregnancy events which within 72 months after first vaccination for all participants

Yunnan Center for Disease Control and Prevention

Mile City Center for Disease Control and Prevention

Qiubei County Center for Disease Control and Prevention

Yanshan County Center for Disease Control and Prevention

National Institutes for Food and Drug Control, China

Shanghai Stem Pharmaceutical Development Co., Ltd.

Beijing Health Guard Biotechnology, Inc

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.

AIJP (Arnebia Indigo Jade Pearl)

Placebo

Misha R Cohen, OMD, LAc

Naomi Jay, PhD, FNP

The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

Phase II Study for Treatment of Anal HSIL Through Use of a Chinese Herbal Topical Cream

Response assessed 12 weeks after treatment.

Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.

Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement \>50% in the number of lesions with HSIL, or an improvement \>50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)

No Response (NR): HSIL present at weeks 48 \& 60 on histology, or improvement ≤ 50% in number, size, area or characteristics.

Percent of recommended applications of cream reported in participant diary.

\>75% = Excellent \>50%-75% = Good \>25%-50% = Poor \<25% = Non-adherent

Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.

Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.

Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement \>50% in number of lesions with HSIL, or improvement \>50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)

No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.

Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.

Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.

Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)

Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement \>50% in the number of lesions with HSIL, or an improvement \>50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)

No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics.

Spring Wind Herbs

University of California, San Francisco

AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.

AIJP

Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.

Total

24-39 years

40-59 years

60-74 years

Age, Customized

Women

MTF (transgender)

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Naomi Jay, PhD

Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)

Excellent

Good

Poor

Non-adherent

Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.

Treatment Adherence

Evaluable participants who finished 48 weeks of treatment and reported \>50% adherence to treatment

Response With >50% Adherence

Evaluable participants who finished 48 weeks of treatement and reported \>75% adherence to treatment

Response With >75% Adherence

Baseline - Week 12 (Treatment)

Week 12 - Week 48 (Treatment)

Week 60 (Post-treatment Follow-up Visit)

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Papilloma

Immunologic Factors

Intramuscular Saline 0.9% vaccination at 0, 2 and 6 months

Intramuscular Gardasil vaccination at 0, 2 and 6 months.

Gardasil

Jan M Prins, prof, MD, infectiologist

Henry JC de Vries, prof, MD, dermatologist

This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex with men) who were successfully treated for high grade AIN.

Rationale: Since the introduction of combination antiretroviral therapy (cART), human immunodeficiency virus (HIV)-related morbidity and mortality have considerably decreased. However, as a result of the significantly prolonged life span, new causes of morbidity and mortality have become evident. In particular, anal cancer incidence has increased dramatically in HIV-positive men. Like cervical cancer, anal cancer is causally linked to infections with high-risk papillomaviruses, and is preceded by precursor lesions: anal intraepithelial neoplasia (AIN). Over 90% of HIV-positive MSM (men who have sex with men) have persisting anal HPV (human papilloma virus) infection, and high-grade (HG) AIN is present in 30% of all HIV+ MSM.

As in cervical intraepithelial neoplasia, early diagnosis and treatment of AIN have been advocated to prevent malignancy. Electrocoagulation/ cauterization is standard of care for intra-anal AIN, but after treatment, recurrence of lesions occurs in approx. 50% of cases. This is a major problem in an effective screening program for AIN.

In a nonconcurrent, non-blinded cohort study qHPV (quadrivalent human papilloma virus) vaccination significantly (HR 0.50) reduced HG AIN recurrence among MSM successfully treated for AIN. This is in accordance with findings in women treated for cervical intraepithelial neoplasia. Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease.

Therefore, a strategy that is worth investigating is vaccination with the qHPV vaccine to prevent recurrences in HIV+ MSM who were successfully treated for HG AIN.

Objective: The primary objective of the current study is to assess the efficacy of qHPV vaccination in preventing recurrence of high-grade AIN in HIV+ MSM with CD4 counts \>350 x 10E6/l who were successfully treated for high-grade intra-anal AIN in the past year.

Study population: HIV-positive MSM with a CD4 count \> 350 cells/ul and intra-anal high-grade AIN (grade 2-3) that was successfully treated in the past year with conventional cauterization, cryotherapy, or other forms of local treatment.

Study design: A multicenter, randomised, double-blind clinical trial in four hospitals in the Netherlands.

Intervention: Patients are randomised for vaccination with the quadrivalent HPV vaccine (Gardasil ®) or vaccination with a matching placebo at months 0, 2 and 6.

Randomisation will be stratified for complete response versus partial response (from HG AIN to low-grade (LG) AIN) of the initial HG AIN lesion, for treatment less than 6 months ago versus treatment 6 months and longer ago, and for AMC versus other hospitals.

Main study parameters/endpoints: Screening for AIN will be performed by high-resolution anoscopy (HRA), at inclusion (first vaccination) and at last vaccination (6 months), and repeated at 6 and 12 months after the last vaccination. Safety Monitoring for adverse events and injection-site reactions will be performed one week after each vaccination and thereafter every 6 months for a total of 12 months of follow-up.

Primary end point will be the cumulative recurrence of HG AIN at 12 months after the last vaccination, as assessed by HRA (High-Resolution Anoscopy), with biopsies taken of suspect lesions.

Secondary outcome measures are toxicity/ safety, recurrence of HG AIN at last vaccination and 6 months afterwards, cumulative occurrence of LG AIN at 12 months after the last vaccination, cumulative occurrence of anogenital warts at 12 months after the last vaccination, causative HPV type in recurrent AIN lesions, as assessed by LCM (Laser Capture Microdissection)/ PCR (polymerase chain reaction), and HPV type-specific antibody response.

The total sample size is estimated to be 125 patients based on an expected recurrence rate of 50% within 12 months. Statistical analysis will be based on the intention-to-treat principle. Both primary and secondary endpoints will be analyzed by descriptive statistics and the chi-square test with a 0,05 two-sided significance level.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

HIV+ MSM who were successfully treated for HG AIN are still at a 50% risk for recurrences, with additional treatment sessions needed, and an ongoing risk for malignant degeneration of lesions.

Costs of 3 vaccinations are approx. € 400, but if vaccination reduces recurrence rates by 50%, this will be a highly cost-effective intervention, very likely to be introduced into regular care.

For the study, patients will be vaccinated 3 times with the quadrivalent vaccine Gardasil ® or placebo, and will undergo two extra HRAs. Clinical trial data show that the most common adverse events of Gardasil ® were mild or moderate, so few risks are associated with study participation.

HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)

Quadrivalent HPV Vaccination After Effective Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

One week after each vaccination and during all follow up visits the most common adverse events of Gardasil and other eventually occuring complaints will be evaluated by history taking. Adverse events will be graded according to the CTCAE v4 (Common Terminology Criteria for Adverse Events), which grades events on a scale of 1 to 5, with higher grades indicating greater severity.

The patients with LG AIN at inclusion are excluded from this analysis.

Evaluated by physical examination and history taking.

Prof. Jan Prins

Professor. dr. J.M. Prins

Nervous System Diseases

Pain, Postoperative

Pain

Fecal Incontinence

Carcinoma

Carcinoma in Situ

Postoperative Complications

Neurologic Manifestations

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

functional studies before and after anal laser ablation

high resolution anal manometry

Tamzin Cuming, FRCS

Christine Inwang, MSc

Tamzin Cuming, FRCS, MBBS

Mayura Nathan, FRCS

High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.

High resolution anoscopy with targeted laser ablation is one of the therapies currently employed to treat HSIL of the anus to prevent progression to anal cancer. The functional outcome of this procedure has not previously been formally assessed.

HIV and negative positive MSM in whom HSIL has been detected will form the study population, as HSIL is prevalent in these patients and intervention is felt to be indicated. Functional assessments will be carried out prior to initial treatment and then repeated six months after laser ablation therapy. The structure, function and sensitivity of the anal canal will be evaluated using endoanal ultrasound, high-resolution anal manometry and anal mucosal electrosensitivity measurements respectively. Patient-reported outcomes will be assessed using questionnaires and semi-structured interviews at baseline, 4 weeks and 6 months post-treatment.

Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)

Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values

Changes in sensitivity as measured against patients own pre treatment perception

Changes in endoanal ultrasound abnormalities compared to pre-treatment findings

Qualitative subjective physical and psychological well-being 4 weeks and 6 months after procedure of laser mucosal ablation of AIN

Patient reported outcomes, particularly with regard to sexual function and bowel function

Barts & The London NHS Trust

Homerton University Hospital NHS Foundation Trust

Neoplasms, Squamous Cell

Other Dietary Supplements

Brewer's Yeast

For Mid-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg#40μg#60μg#40μg#20μg#20μg#20μg#20μg and 20μg respectively, totaling 270μg of antigens.

For High-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg#40μg#80μg#60μg#30μg#30μg#30μg#30μg and 30μg respectively, totaling 360μg of antigens.

0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens.

For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6.

For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.

Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

A 3-dose regimen administered at months 0, 2 and 6.

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

This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.

This is a single-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV vaccine GARDASIL®) Phase II clinical trial.

The trial will recruit a total of approximately 780 Chinese women 20-45 years of age with permanent residence. Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively.

Each subject will be administered 0.5 ml of the investigational vaccine or control in accordance with a 3-dose regimen at months 0, 2 and 6.

Peripheral blood samples of each subject will be collected at Day 0 (prior to dose 1), Month 7 (1 month post dose 3) to determine the levels of neutralizing antibodies and IgG antibodies to HPV types 6/11/16/18/31/33/45/52/58 in the sera. Optimal ratio of the antigens included in the investigational vaccine will be decided based on the immunogenicity and safety data from this trail.

Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control, respectively.

A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine

A Phase II Trial in Healthy Chinese Women Ages 20-45 to Evaluate the Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reactions up to Day 7 after each dose of the interventions

To determine the optimal ratio of antigens included in the investigational vaccine through non-inferiority analysis of the GMTs of neutralizing antibodies specific to vaccine HPV types 6, 11, 16 and 18 elicited by the investigational vaccine versus those induced by the positive control, in subjects negative for antibodies to such vaccine HPV types prior to dose 1.

Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse events up to Day 30 after each dose of the interventions

Percentage of subjects with serious adverse events for the duration of the study (from Day 1 till Month 7)

To demonstrate that the levels of neutralizing antibodies specific to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil through assessing the GMTs of neutralizing antibodies to HPV types 31, 33, 45, 52 and 58 in the sera of the subjects who are negative for antibodies to such HPV types prior to dose 1 of the investigational vaccine in comparison with those administered Gardasil.

Subgroup Analysis: To evaluate the levels of neutralizing antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1.

Subgroup Analysis: To evaluate the levels of IgG antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1.

Subgroup Analysis: To evaluate the rates of seropositivity to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1.

Subgroup Analysis: To evaluate the rates of seroconversion to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1.

To evaluate the levels of neutralizing antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.

To evaluate the levels of IgG antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.

To evaluate the rates of seropositivity to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.

To evaluate the rates of seroconversion to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.

Jiangsu Province Centers for Disease Control and Prevention

Nanjing Sangruisi pharmtech Ltd.

Shanghai Canming pharmtech Ltd.

HIV Seropositivity

Human immunodeficiency virus (HIV) positive adult men who have sex with men that are members of KPNC (Kaiser Permanente Northern California) and do not have a current anal cancer diagnosis.

Nicolas Wentzensen, M.D.

Background:

* HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach those of cervical cancer in women. However, unlike cervical cancer, there is no current recommended method of screening that could be used to detect anal precancerous lesions for the prevention of anal cancer in HIV-positive MSM.
* Infections by human papillomavirus (HPV) are the likely cause of cervical and anal precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to identify women who may be at increased risk of cervical cancer; researchers believe that early detection of HPV or related biomarkers in MSM may be useful for anal cancer screening.

Objectives:

- To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive men who have sex with men.

Eligibility:

- HIV-positive MSM that are interested in receiving anal screening for precancer

Design:

* HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will undergo a physical exam and a high-resolution anoscopy at the participating clinic.
* The clinician will then collect to anal Pap specimens from each subject for research on HPV and related biomarkers.
* Participants will be followed annually for 2 years to collect additional health data for research follow-up.

BACKGROUND:

Human immunodeficiency virus (HIV) positive men who have sex with men (MSM) are at risk of anal cancer that approaches the risk of cervical cancer for unscreened women living in developing countries. There is currently no accepted method for screening HIV positive MSM for anal precancer to reduce the morbidity and mortality due to anal cancer ; in the absence of a standard and effective screening modality, clinics often resort to anoscopy, a diagnostic procedure akin to colposcopy, and directed biopsies on all HIV positive MSM.

OBJECTIVE:

Evaluate the clinical performance of detecting carcinogenic human papillomavirus (HPV) DNA and RNA, individual carcinogenic HPV genotypes, cytogenetic markers, p16(INK4a) and Ki-67 immunocytochemistry staining, anal cytology, and combinations of these biomarkers for identifying HIV positive MSM with prevalent, 1 year cumulative, and 2 year cumulative anal precancer and cancer (histologically-confirmed greater than or equal to AIN3) using clinician-collected anal specimens at baseline.

ELIGIBILITY:

HIV positive MSM seeking anal cancer screening. Inclusion: 1) KPNC member; 2) documented HIV-positive status; 3) able and mentally competent to provide written, informed consent. Exclusion:A current diagnosis of anal cancer at enrollment.

DESIGN:

To address this need and to improve detection of anal precancer and cancer, we propose a screening cohort study of 1,000 HIV positive MSM participating in the Kaiser Permanente Northern California (KPNC) health maintenance program. Under written, informed consent, participating KPNC members will respond to a self-administered risk factor questionnaire and will undergo two anal specimen collections into liquid-based cytology (LBC) medium prior to a digital exam and high resolution anoscopy. Subjects will be asked to self-collect at home into the same LBC buffer and return their specimen in a prepared return envelope to evaluate the utility of self-collection for anal cancer screening. Subjects will be followed annually for two years to collect follow-up clinical data related to outcomes. Baseline clinician-collected specimens will be tested in a masked fashion for the following clinical biomarkers: 1) carcinogenic HPV DNA in aggregate and individual carcinogenic HPV genotypes; 2) carcinogenetic HPV RNA and HPV16/18 RNA; 3) cytogentic changes (3q, 5p, and 20q amplification); and 4) p16(INK4a) and Ki-67 immunocytochemical staining. For reference, clinician-collected specimens will be used to make LBC slides and evaluated by an expert cytopathology laboratory. We will estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and referral rates) for detection of prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed anal precancer (anal intraepithelial neoplasia grade 3) or worse (greater than or equal to AIN3). We will test the self-collected anal specimens by the best molecular test(s) or combination of tests for detection of prevalently-detected greater than or equal to AIN3 as determined from testing the clinician-collected specimens. All MSM will undergo diagnostic procedures at all visits and independent of testing results, which will result in unbiased disease ascertainment.

Anal Cancer Screening Study

Detection of AIN2 and AIN3 in high resolution anoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China	NCT05662020	Human Papilloma...	Recombinant Non... GARDASIL® 9	9 Years - 26 Years	Beijing Health Guard Biotechnology, Inc
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco
HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)	NCT02087384	AIN HIV	Gardasil Placebo	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)	NCT04109573	Anus Cancer Fecal Incontine... Anal Intraepith... Post Operative ...	high resolution...	18 Years -	Homerton University Hospital NHS Foundation Trust
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine	NCT05694728	Human Papilloma...	Recombinant Non... Recombinant Qua...	20 Years - 45 Years	Beijing Health Guard Biotechnology, Inc
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine	NCT05694728	Human Papilloma...	Recombinant Non... Recombinant Qua...	20 Years - 45 Years	Beijing Health Guard Biotechnology, Inc
Anal Cancer Screening Study	NCT00914537	Anal Cancer		18 Years - 110 Years	National Institutes of Health Clinical Center (CC)
A Safety and Tolerability of Circumferential Anal Canal Radiofrequency Ablation For Anal Intraepithelial Neoplasia	NCT02189161	Anal Intraepith... High-grade Squa...	Radiofrequency ...	18 Years - 75 Years	Medtronic - MITG
A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine	NCT05680454	Human Papilloma...	Recombinant Non... Recombinant non...	18 Years - 45 Years	Beijing Health Guard Biotechnology, Inc
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream	NCT00622440	Anus Neoplasms	AIJP (Arnebia I... Placebo	18 Years - 99 Years	University of California, San Francisco

Spots Global Cancer Trial Database for ain

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Spots Global Cancer Trial Database for ain

Every month we try and update this database with for ain 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 ain 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.