A Non-Randomized, Open-Label Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination.
- Conditions
- Human PapillomavirusMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-005229-26-ES
- Lead Sponsor
- Dr. Miguel Angel Pavón Ribas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 69
-Are women, aged 35 or 27 years or older for cohort 1 and cohort 2 respectively, attending a routine cervical cancer screening visit or gynaecological visit, are positive for HPV16, 18 or double-positive for 16 and 18 and negative for the rest of high-risk HPV types in a cervical sample, have been recently
diagnosed for their HPV-positivity (within the last 24 months) and meet one of the following criteria:
- have no apparent cervical lesion (cohort 1).
- have a CIN1/2 lesion which is eligible for conservative treatment (cohort 1).
- have multiple cervical, vulvar and/or anal lesions, and cervical lesions are eligible for conservative treatment (cohort 2).
-Are judged to have no major health conditions (based on medical history, physical examination, and laboratory testing) that may compromise their capacity to comply with study procedures.
-Provide written informed consent for their participation in the study.
-Provide a frequent contact telephone number as well as an alternate means of contact (such as an alternate telephone number or email) for follow-up purposes.
-Are planning to stay in their area of residence (near the study site) for the full duration of the study, so it is convenient for them to attend study visits at the site.
The following conditions ARE NOT CONSIDERED EXCLUSION CRITERIA. Therefore, candidates complying with them ARE ELIGIBLE FOR INCLUSION in the study:
-History of cervical surgery.
-History of condyloma acuminata.
-History of HIV or other immunosuppressive conditions, either acquired or medically induced.
-History of transplant immunosuppression.
-History of an autoimmune disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 69
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Medical Conditions
-Have any cervical lesion that requires clinical intervention within 7 months that could significantly affect cervical epithelia (and therefore, HPV viral production), such as cervical conization.
-Have a fever (defined as temperature =37.8°C) within the 24-hour period prior to the Day 1 visit*.
-Have a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficultybreathing, hypotension, or shock) that required medical intervention.
-Are allergic to any vaccine component, including aluminium, yeast, or BENZONASETM (nuclease, Nicomedia [used to remove residual nucleic acids from this and other vaccines]). For this exclusion criterion, an allergy to vaccine components is defined as anallergic reaction that met the criteria for severe adverse event (SAE), defined as any
untoward medical occurrence that results in death, is life-threatening, requires hospitalization or results in persistent or significant disability/incapacity.
-Have known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection of study vaccine.
-Have a history of splenectomy.
-Have a history of ano-genital cancer or HPV-related head and neck cancer.
-Have a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study or interfere with the subject’s compliance of study procedures for the full duration of the study, such that their inclusion
in the study is not in the best interest of the subject and/or may compromise fulfilment of study’s objectives, by judgement of the investigator.
-Are, at the time of signing informed consent, using recreational or illicit drugs or have had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator that might interfere with her capacity to comply with study
procedures. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use.
-Are pregnant at the time of signing informed consent, are planning to be within the full duration of the study or become pregnant during the study period.
*For items denoted with an asterisk, if the exclusion criterion is met, then the Day 1 visit may
be rescheduled for a time when the criterion is not met.
Prior/Concomitant Therapy
-Have previously received any HPV vaccine.
-Have received within the 3 months prior to the Day 1 vaccination, are receiving, or plan to receive during Day 1 through Month 7 of the study, any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product other than IVIG.
-Have received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination, or live vaccines within 21 days prior to Day 1 vaccination*.
Prior/Concurrent Clinical Study Experience
-Are concurrently enrolled in other clinical studies of investigational agents.
Sexual Activity
-Have engaged in sexual activity 48 hours prior to Day 1 (this may result in the detection of viral DNA that has been deposited in the oral cavity and is not the result of ongoing infection) * Sexual activity is defined as:
- Penile penetrative vaginal intercourse.
- Penile penetrative anal intercourse.
- Oral sex involving any contact between subject’s mouth with a partner’s genital or anal area.
*: For items denoted with an asterisk, if the exclusion criterion is met, then the Day 1 visit may be reschedu
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method