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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Human Papillomavirus Infections

In brief

The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.

Key facts

Study ID: NCT03610581
Run by: Janssen Vaccines & Prevention B.V.
People needed: 9
Starts: 2018-09-27
Expected to finish: 2020-10-15
Last updated by the study team: 2025-02-04

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Doral Medical Research — Doral, Florida, United States
Clinical Physiology Associates — Fort Myers, Florida, United States
Florida Research Center Inc. — Miami, Florida, United States
San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
University of Iowa Hospital — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Heartland Research Associates, LLC — Newton, Kansas, United States
Medpharmics, LLC — Metairie, Louisiana, United States
Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
Columbia University Medical Center — New York, New York, United States
VGR & NOCCR - Knoxville — Knoxville, Tennessee, United States
UZ Leuven — Leuven, Belgium

Full record on ClinicalTrials.gov

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