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Completed

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rockville, Maryland, United States

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

Biological

Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).

MVA-BN-Filo

Biological

MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).

Ad26.ZEBOV

Biological

Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.

Placebo

Biological

IM injection of 0.9 percent saline.

Primary outcomes

  1. Number of Participants With Adverse events (AEs)

    Time frame: Up to 28 days after the last vaccination

  2. Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events)

    Time frame: One Week after each study vaccine administration

  3. Number of Participants With Serious Adverse Events

    Time frame: Up to the end of long-term follow-up (Day 360)

Secondary outcomes

  1. 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.

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