Rockville, Maryland, United States
NCT Number: NCT02860650
A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Body mass index (BMI) of greater than or equal to (>=) 18.5 and less than (<) 35.0 kilogram per square meter (kg/m^2)
- Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment
- All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination
- Participant must be available and willing to participate for the duration of the study visits and follow-up
Exclusion criteria
- Has been vaccinated with a candidate filovirus vaccine
- Has received any Ad26- or MVA-based candidate vaccines in the past
- Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study
- Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (>=) 38.0 degree Celsius on Day 1
Treatment and study plan
Ad26.Filo
BiologicalAd26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
MVA-BN-Filo
BiologicalMVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
Ad26.ZEBOV
BiologicalAd26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.
Placebo
BiologicalIM injection of 0.9 percent saline.
Primary outcomes
-
Number of Participants With Adverse events (AEs)
Time frame: Up to 28 days after the last vaccination
-
Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events)
Time frame: One Week after each study vaccine administration
-
Number of Participants With Serious Adverse Events
Time frame: Up to the end of long-term follow-up (Day 360)
Secondary outcomes
-
Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs)
Time frame: Up to Day 360
Sponsors and collaborators
Lead sponsor
Janssen Vaccines & Prevention B.V.
Industry
Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Registry information
Official study title
A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Aug 9, 2016
- Registry last updated
- Feb 5, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAI Chatbot for HPV Vaccine Literacy Among Caregivers in Japan
NCT06702423
Healthy
London, United Kingdom
View Trial DetailsValidation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
NCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNormative Value for Navicular Drop Test in Older Adults
NCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details