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



Status:Recruiting
Conditions:Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:18 - 60
Updated:3/22/2019
Start Date:September 27, 2018
End Date:March 10, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With Persistent HPV16 or 18 Infection of the Cervix

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

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
We found this trial at
15
sites
Rocky Mount, North Carolina 27804
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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Columbus, Ohio 43235
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Doral, Florida 33166
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Iowa City, Iowa 52242
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1928 Alcoa Highway
Knoxville, Tennessee 37920
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Knoxville, TN
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10555 West Flagler Street
Miami, Florida 33174
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Miami Lakes, Florida 33014
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newton, Kansas 67114
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Newton, KS
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Norfolk, Nebraska 68701
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Norfolk, NE
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Raleigh, NC
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Wilrijk,
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