Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
Purpose
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Condition
- Human Papillomavirus Infections
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol - Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded - Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure - Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies - Agrees not to donate blood until 3 months after receiving the last dose of study vaccine
Exclusion Criteria
- In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia - Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer - Confirmed co-infection with both HPV16 and HPV18 - History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments - Tests positive for human immunodeficiency virus (HIV) at screening - Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively - Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators - Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study - Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example [e.g.], prolapse, myoma, fibroid, hysterectomy) - Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 |
Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization. |
|
|
Experimental Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 |
Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. |
|
|
Experimental Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 |
Participants will receive a mix of Ad26.HPV16/Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. |
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|
Placebo Comparator Control: Placebo |
Participants will receive matched placebo as prime and boost immunizations. |
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More Details
- Status
- Terminated
- Sponsor
- Janssen Vaccines & Prevention B.V.
Study Contact
Detailed Description
This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.