Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

The participants who have already received 2 doses of the quadrivalent HPV vaccine (0, 6 months schedule) 5 years before recruitment will not receive an additional dose.

The participants will receive a 3rd dose of quadrivalent HPV vaccine at recruitment visit, which is 5 years after having received two doses of vaccine given 6 months apart in grade 4 (0, 6, 60 months Schedule)

One dose of Gardasil administered in the intervention group

Quadrivalent HPV vaccine

This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination.

The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.

ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV

Centre hospitalier de l'Université de Montréal (CHUM)

Ministere de la Sante et des Services Sociaux

Institut National en Santé Publique du Québec

CHU de Quebec-Universite Laval

Co-principal investigator

Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Sintilimab 200 mg intravenously every 3 weeks ，3 doses of quadrivalent HPV vaccine intramuscularly at day 1,60,180

Sintilimab 200 mg intravenously every 3 weeks

Sintilimab

The first dose of quadrivalent HPV vaccine intramuscularly at the day before the first dose of Sintilimab ，the second and third doses of quadrivalent HPV vaccine intramuscularly at the 60th and 180th days respectively

quadrivalent HPV vaccine

Buhai Wang

Yuechao Wu

Buhai Wang, MD/PhD

Yuechao Wu, master

Liqin Liu, master

Yichen Liang, MD

Yinxia Wu, MD

Yuxiang Huang, PhD

Feng Han, master

Xiaosong Ma, master

The investigators propose to evaluate the efficacy of the combination of Pd-1 Monoclonal Antibody and HPV Vaccine in the patients with cervical cancer who fails in or can not endure the standard treatment

The phase II study is a research which treat cervical carcinoma patients who recurred after at least one prior chemotherapy regimen with Sintilimab and HPV Vaccine. The primary endpoint is objective response rate; secondary endpoints are Progression-Free Survival, Overall Survival and duration of response. Efficacy will be assessed according to RECIST 1.1; progression-free survival is the time from study entry to time of progression or death, whichever occurs first; overall survival is the time from study entry to time of death or the date of last contact,. Furthermore, exploratory studies will be performed on archival tumor material (PD-L1 expression, next-generation sequencing).

Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer

A Single-arm, Single-center, Phase II Clinical Study Evaluating Efficacy of PD-1 Monoclonal Antibody Combined With HPV Vaccine in the Patients With Cervical Cancer（CC）Who Fails in or Can Not Endure the Standard Treatment

complete response plus partial response as determined by RECIST 1.1

Kaplan-Meier median estimates and curves will be used to describe PFS survival functions

Kaplan-Meier median estimates and curves will be used to describe OS survival functions

Kaplan-Meier median estimates and curves will be used to describe DOR survival functions

Innovent Biologics (Suzhou) Co. Ltd.

doctor

Skin and Connective Tissue Diseases

Recurrence

Papilloma

Warts

Condylomata Acuminata

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Immunologic Factors

Three doses of 4 HPV vaccine is given at registered intervals.

Three doses of Hepatitis B vaccine is given at the same intervals as the quadrivalent HPV vaccine.

Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.

Hepatitis B vaccine

Greta G Dreyer, MMed(O&G)PhD

Large genital warts are frequently diagnosed in general gynaecology and oncology clinics in South Africa. Medical and destructive therapy for small warts is generally very effective, however unique problems posed by large or extensive genital warts are not so easily solved and treatment of affected patients remains very challenging. Recurrences are common especially among immune-compromised women. This study will test whether giving the quadrivalent human papilloma virus (HPV) vaccine to women with extensive genital warts prior to surgical treatment will improve outcomes. Investigators hypothesize that pre-treatment with HPV vaccine can play a role in the control of both malignant and benign HPV disease in women with and without HIV infection through stimulation of the antibody response. In addition, HPV types and other associated diseases will be studied in women receiving HPV vaccine and placebo.

Patient selection:

Female patients referred or presenting with genital warts at each site will be eligible and evaluated against the inclusion and exclusion criteria.

Women who are clinically or severely immune-compromised will not be included into the study, but both HIV negative and HIV infected women will be included. Seventy-five women with large or recurrent genital warts will be recruited for this study from 2 sites in South Africa.

Recruitment:

Women with genital warts will be evaluated for inclusion into the study. Those who fit the inclusion criteria and are without any of the exclusion criteria will be fully informed and invited to participate. The first target will be to recruit the first seventy-five consecutive eligible patients who have signed written consent; recruitment for the study will be done for at least 24 months.

First clinical visit:

* Evaluation genital lesions:

On study entry tumour size and position will be documented graphically and photographically and viral typing from the vulva wart and cervix will be done using Roche Linear Array test.

* Evaluation immune status:

HIV status and CD 4/CD 8 count will be recorded and tested and the serum will be collected for antibody testing. Cervical disease of clinical significance will be excluded or treatment offered if relevant.

* Randomization:

Patients will be randomized to receive either quadrivalent HPV or Hepatitis B vaccine.

* Vaccination:

The participants assigned to the test group will be administered quadrivalent HPV vaccine in three doses as recommended by the manufacturer. Participants assigned to the control group will receive Hepatitis B vaccine in three doses as recommended by the manufacturer.

Follow-up clinical visits: week 8, week 16 and week 24:

* Evaluation genital lesions:

Three follow up visits will be scheduled two months apart at which time the lesion size will be recorded.

* Evaluation immune status:

After month 6 or the third visit, the serum will again be collected for antibody level testing.

* Treatment decision:

According to the clinical response as measured at month six and onwards, locally destructive or surgical treatment will be allowed according to the preference of the clinician and as determined by clinical factors.

Follow up after treatment:

* Follow up will be done at six monthly intervals.
* Evaluation genital lesions:

At these visits lesion size will be determined and documented. HPV typing on the cervical and vulval lesions will be repeated at least once.

* Further treatment of warts:

If needed, repeat surgery and/or local destruction will be allowed and documented. These will be around week 48 and week 72, or study exit

Study exit:

* Participants will exit the study in week 72.
* In the absence of harm as determined at interim analysis or suggested by participant disease history, researchers will be unblinded for participant status at study exit and alternative vaccines will be offered to each of these women.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV	NCT02009800	Human Papilloma...	Quadrivalent HP...	14 Years - 16 Years	CHU de Quebec-Universite Laval
Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer	NCT04096911	Uterine Cervica... Cervical Cancer Cervical Neopla... Cervix Cancer	Sintilimab quadrivalent HP...	18 Years -	Northern Jiangsu People's Hospital
Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts	NCT02750202	Genital Warts	Quadrivalent HP... Hepatitis B vac...	16 Years -	University of Pretoria

Spots Global Cancer Trial Database for quadrivalent hpv vaccine