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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 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 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.
Age
18 - 60 years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
September 27, 2018
Primary Completion Date
October 15, 2020
Completion Date
October 15, 2020
Last Updated
February 4, 2025
9
ACTUAL participants
Ad26.HPV16
BIOLOGICAL
Ad26.HPV18
BIOLOGICAL
MVA.HPV16/18
BIOLOGICAL
Placebo
BIOLOGICAL
Lead Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
Data Source & Attribution
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