An early phase study of 2 experimental vaccines vs dummy vaccines for the treatment of HPV (Human Papillomavirus) in women with low grade cervical lesions to determine the best dose, effectiveness and safety of the vaccines.
- Conditions
- Persistent hrHPV infection in participants with low grade cervical lesionsMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2019-001890-98-GB
- Lead Sponsor
- Vaccitech Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 105
Participants must meet all the following criteria to be eligible for the study:
1. Females aged =25 and =55 years of age at screening.
2. Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participants in the lead in phase are only required to have the screening result.
3. Low grade cervical lesion (CIN1 or HPV related change only) confirmed by histology and/or cytology report within the 1 year prior to screening.
4. Not pregnant or breast feeding and one of the following:
• Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause.)
• Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to administration of the first dose of study vaccine and throughout the study until 8 weeks after administration of the second dose. Highly effective methods of contraception include one or more of the following:
- Male partner who is sterile (medically effective vasectomy) prior to the female participant’s entry into the study and is the sole sexual partner for the female participant
- Hormonal (oral, intravaginal, transdermal, implantable or injectable). Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective.
- An intrauterine hormone releasing system
- An intrauterine device
- Bilateral tubal occlusion
5. Willing to abstain from sexual activity for 48 hours prior to all swabbing procedures.
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 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Participants who meet any of the following criteria are not eligible for the study:
1. Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscracias.
2. Immunosuppression as a result of underlying illness or treatment including:
• Use of high dose corticosteroids (>10 mg/day prednisone or equivalent) for =7 days (inhaled, otic and ophthalmic corticosteroids are permitted)
• Primary immune deficiency disease
• Use of synthetic or biologic disease-modifying antirheumatic drugs
• History of bone marrow or solid organ transplant
• History of any other clinically significant autoimmune or immunosuppressive disease
3. Positive diagnostic tests (for HIV, hepatitis B, or HCV) indicating chronic infection.
4. Evidence of high grade cervical lesions by colposcopy or by Pap smear test in the 1 year prior to screening.
5. Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine.
6. Receipt of any investigational drug or investigational vaccine within 3 months prior to administration of ChAdOx1-HPV on Day 0, or prior participation in a clinical study of any HPV vaccine.
7. Any history of receipt of any adenoviral or MVA based vaccine.
8. Receipt of any live vaccines within the 30 days or inactivated vaccine within the 14 days prior to administration of ChAdOx1 HPV on Day 0 or planned to occur in the 2 months after the Day 0 vaccination.
9. Current or history of illicit drug use within the 6 months prior to screening.
10. Current or history of severe alcohol abuse within the 6 months prior to screening.
11. Any laboratory test which is abnormal and deemed by the Investigator to be clinically significant which will potentially affect the participation in the study.
12. Current known infection with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) as evidenced by PCR laboratory testing.
13. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.
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