Last updated on August 2019

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


Brief description of study

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

Detailed Study Description

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.

Clinical Study Identifier: NCT03610581

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