Trials / Terminated
TerminatedNCT03610581
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
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-09-27
- Primary completion
- 2020-10-15
- Completion
- 2020-10-15
- First posted
- 2018-08-01
- Last updated
- 2025-02-04
- Results posted
- 2021-11-09
Locations
12 sites across 2 countries: United States, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03610581. Inclusion in this directory is not an endorsement.