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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

NCT03610581 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-02-04

Study results available
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Summary

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

Conditions

  • Human Papillomavirus Infections

Interventions

BIOLOGICAL

Ad26.HPV16

Participants will receive Ad26.HPV16 as a solution for intramuscular injection.

BIOLOGICAL

Ad26.HPV18

Participants will receive Ad26.HPV18 as a solution for intramuscular injection.

BIOLOGICAL

MVA.HPV16/18

Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.

BIOLOGICAL

Placebo

Participants will receive matched placebo as a solution for intramuscular injection.

Sponsors & Collaborators

  • Bavarian Nordic

    collaborator INDUSTRY

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2020-10-15
Completion
2020-10-15
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610581 on ClinicalTrials.gov