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

Human Papillomavirus Infections Clinical Trial

Official title: 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

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Human Papillomavirus Infections
• Infections
• Papillomavirus Infections

• NCT number: NCT03610581
• Study type: Interventional
• Source: Janssen Vaccines & Prevention B.V.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 27, 2018
• Completion date: October 15, 2020