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

• ClinicalTrials.gov Identifier: NCT03929757
• Recruitment Status: Completed
• First Posted: April 29, 2019
• Last Update Posted: November 25, 2022
• Sponsor: Janssen Vaccines & Prevention B.V.
• Collaborators: London School of Hygiene and Tropical Medicine; College of Medicine and Allied Health Sciences (COMAHS); Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Janssen Vaccines & Prevention B.V.

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Ebola Virus Disease	Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo; Biological: MenACWY	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: August 19, 2019
• Actual Primary Completion Date: August 22, 2022
• Actual Study Completion Date: September 22, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1: Ad26.ZEBOV, MVA-BN-Filo; Participants will be administered 0.5 mL of Ad26.ZEBOV vaccine (5*10^10 viral particles [vp]) on Day 1 by intramuscular (IM) injection followed by 0.5 mL of MVA-BN-Filo (1*10^8 infectious units [Inf U]) vaccine by IM injection on Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit. Upon completion of the main study, participants in the extension phase who were originally randomized to the control arm will receive the same vaccine regimen as the participants in the Ad26.ZEBOV, MVA-BN-Filo arm of the main study.	Biological: Ad26.ZEBOV; Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.; Biological: MVA-BN-Filo; Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.; Biological: MenACWY; Participants will receive 0.5 mL IM injection of MenACWY.
Active Comparator: Arm 2: MenACWY; Participants will be administered 0.5 mL of MenACWY vaccine by IM injection on Day 1 and Day 57. Participants will also receive a dose of MenACWY at the 6-months post-dose-2 visit.	Biological: MenACWY; Participants will receive 0.5 mL IM injection of MenACWY.

Outcome Measures

Primary Outcome Measures :

1. Main Study: Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Up to 7 days post-dose-1 (Day 8) ]
   Following local AEs: pain, erythema, and swelling at the study vaccine injection site, and systemic AEs: pyrexia, loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or swelling will be measured daily and recorded, along with any functional limitation of activity.
2. Main Study: Percentage of Participants with Solicited Local and Systemic AEs [ Time Frame: Up to 7 days post-dose-2 (Day 64) ]
   Following local AEs: pain, erythema, and swelling at the study vaccine injection site, and systemic AEs: pyrexia, loss of appetite, vomiting, diarrhea, decreased activity, irritability will be noted in the participant diary for 7 days. The extent (largest diameter) of any redness or swelling will be measured daily and recorded, along with any functional limitation of activity.
3. Main Study: Percentage of Participants with Unsolicited AEs [ Time Frame: Up to 28 days post-dose-1 (Day 29) ]
   Percentage of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
4. Main Study: Percentage of Participants with Unsolicited AEs [ Time Frame: Up to 28 days post-dose-2 (Day 85) ]
   Percentage of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
5. Main Study: Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months post dose-2 (approximately 8 months) ]
   An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
6. Extension Phase: Number of Participants with Completion of the Heterologous 2-dose Vaccination Regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57) [ Time Frame: Up to Day 57 ]
   Number of participants with completion of the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVA-BN-Filo on Day 57) will be reported.

Secondary Outcome Measures :

1. Main Study: Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) [ Time Frame: At 21 days post dose-2 (Day 78) ]
   Serum samples will be collected for analysis of binding antibodies against EBOV GP using filovirus animal nonclinical group enzyme-linked immunosorbent assay (FANG ELISA), to determine humoral responses following vaccination.

Eligibility Criteria

• Ages Eligible for Study: 4 Months to 11 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Guinea

Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah

Conakry, Guinea, 2649

Sierra Leone

College of Med and Allied Health Sciences, University of Sierra Leone

Freetown, Sierra Leone

Sponsors and Collaborators

Janssen Vaccines & Prevention B.V.

London School of Hygiene and Tropical Medicine

College of Medicine and Allied Health Sciences (COMAHS)

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

• Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial; Janssen Vaccines & Prevention B.V.

More Information

• Responsible Party: Janssen Vaccines & Prevention B.V.
• ClinicalTrials.gov Identifier: NCT03929757
• Other Study ID Numbers: CR108617; VAC52150EBL2005 ( Other Identifier: Janssen Vaccines & Prevention B.V. ); 2021-001331-10 ( EudraCT Number )
• First Posted: April 29, 2019
• Last Update Posted: November 25, 2022
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Virus Diseases; Hemorrhagic Fever, Ebola; Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Filoviridae Infections; Mononegavirales Infections; Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic; Antiviral Agents; Anti-Infective Agents