Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With Persistent Human Papillomavirus HPV16 or HPV18 Infection of the Cervix

This study is part of a vaccine program which aims to generate a therapeutic vaccine for
women with persistent 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.

Inclusion Criteria:

- Willing and able to adhere to the prohibitions and restrictions specified in this
protocol

- Must have a 12-month persistent human papillomavirus (HPV) types 16 or 18 infection of
the cervix, defined as at least 2 positive cervical HPV polymerase chain reaction
(PCR) tests with an interval of at least 11 months as follows: 2 positive HPV16 (or 2
positive HPV18) tests or, if the genotype of the first test is unknown and after
consultation with the sponsor, high-risk (HR)-HPV positivity followed by HPV16 (or
HPV18) positivity

- Must have a recent colposcopy result (less than 6 months old at screening)

- 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

- History of or currently active genital herpes disease