Skip to main content
OpenTrials
Completed

NCT Number: NCT03929757

A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants

The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre National de Formation et de Recherche en Sante Rurale de Maferinyah, Conakry, Guinea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parent(s) (preferably both if available or as per local requirements)/guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study, and potential risks and benefits of the study, and are willing to allow their child to participate in the study
  • Parent(s)/guardian are willing/able to ensure that their child adheres to the prohibitions and restrictions
  • The parent(s)/guardian must be at or above the age of legal consent in the jurisdiction in which the study is taking place
  • Infant must be healthy in the investigator's clinical judgment (and the parent(s)/guardian) on the basis of medical history, physical examination, vital signs and clinical laboratory tests performed at screening
  • Infant has received all routine immunizations appropriate for his or her age at the time of enrollment as documented in the vaccination cards presented by the parent(s)/guardian. Participants are allowed to catch up on routine immunizations if needed (support for beneficial vaccines may be offered to participants)
  • Extension Phase: Prior enrollment in the control arm of the main study and did not withdraw consent, and receipt of at least the first vaccination (Dose 1) in the main study

Exclusion criteria

  • Having received any candidate or other Ebola vaccine
  • History of Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with a current Ebola outbreak less than 1 month prior to screening
  • Having received any experimental candidate Ad26- or modified vaccinia ankara (MVA)-based vaccine in the past
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines [for example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine and Neisseria meningitidis polysaccharide or tetanus toxoid for MenACWY]), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin)
  • Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or axillary temperature greater than or equal to (>=) 37.5 degree celsius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
  • Extension Phase: Having received any candidate or other Ebola vaccine

Treatment and study plan

Ad26.ZEBOV

Biological

Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.

MVA-BN-Filo

Biological

Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.

MenACWY

Biological

Participants will receive 0.5 mL IM injection of MenACWY.

Primary outcomes

  1. Main Study: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) up to 7 Days Post-dose 1

    Time frame: From dose 1 (Day 1) up to 7 days post-dose 1 (Day 8)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

  2. Main Study: Percentage of Participants With Solicited Local and Systemic AEs up to 7 Days Post-dose 2

    Time frame: From dose 2 (Day 57) up to 7 days post-dose 2 (Day 64)

    An AE is any untoward medical occurrence in a participants participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site, were pre-defined local (at the injection site) AEs for which participant were specifically questioned and which were noted by participant in their diary for 7 days post vaccination. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

  3. Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 1

    Time frame: From dose 1 (Day 1) up to 28 days post-dose 1 (Day 29)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participants in a nondirected manner.

  4. Main Study: Percentage of Participants With Unsolicited AEs up to 28 Days Post-dose 2

    Time frame: From dose 2 (Day 57) up to 28 days post-dose 2 (Day 85)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner.

  5. Main Study: Percentage of Participants With Serious Adverse Events (SAEs) up to 6 Months Post Dose-2 on Day 57

    Time frame: Up to 6 months post dose-2 on Day 57 (Up to 8 months)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  6. Main Study: Percentage of Participants With SAEs Related to Study Intervention

    Time frame: Up to Day 365

    Percentage of participants with SAEs related to study intervention were reported. A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary outcomes

  1. Main Study: Geometric Mean of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP)

    Time frame: 21 days post-dose 2 (Day 78)

    Geometric mean of binding antibody levels against the EBOV GP were reported.

Sponsors and collaborators

Lead sponsor

Janssen Vaccines & Prevention B.V.

Industry

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • London School of Hygiene and Tropical Medicine
  • University of Sierra Leone

Registry information

Official study title

A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2019
Registry last updated
May 25, 2025

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.

Published trials that share one or more normalized conditions with this study.