NCT03820739

Brief Summary

The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were exposed to these vaccines in the VAC52150EBL3001 trial (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494). No investigational vaccine will be administered during this study. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
653

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

January 25, 2019

Last Update Submit

February 7, 2023

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (3)

  • Number of Serious Adverse Events in subjects who received an Ebola vaccine prime vaccination in the EBOVAC-Salone trial.

    An SAE is any 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.

    Up to approximately 5 years in adults and 4 years in children from prime vaccination

  • Binding antibody responses against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

    Serum Concentration of Antibodies Binding to EBOV GP measured by Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

    Up to approximately 5 years in adults and 4 years in children from prime vaccination

  • Number of Serious Adverse Events, in infants conceived by an EBOVAC-Salone trial female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo.

    An SAE is any 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.

    From birth to their fifth birthday

Secondary Outcomes (2)

  • Neutralising antibody responses directed against EBOV GP as measured by a pseudovirion neutralisation assay (psVNA)

    At years 2, 3 and 4 post-prime in children and years 3, 4 and 5 post-prime in adults

  • Effect of previous infection with malaria, determined using validated ELISA and bead based assays, on the persistence of the humoral immune response to vaccination.

    Up to approximately 5 years in adults and 4 years in children from prime vaccination

Study Arms (2)

Cohort 1

Subjects who received an Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study. Adults are defined as participants 18 years of age or older at the time of prime vaccination, and children are defined as participants aged 1 to 17 years at the time of prime vaccination in EBOVAC-Salone.

Other: Follow-upOther: Blood sample collection

Cohort 2 (offspring)

Infants conceived by a female participant in EBOVAC-Salone during the 3 months following vaccination with Ad26.ZEBOV or during the 28 days following vaccination with MVA-BN®-Filo.

Other: Follow-up

Interventions

Follow-upOTHER

No investigational vaccine will be administered during this study

Cohort 1Cohort 2 (offspring)
Blood sample collectionOTHER

Blood sampling to assess vaccine-induced immune responses will be conducted only in cohort 1 in a subsample consisting of approximately 102 adults and 165 children (55 from each of the three paediatric age groups that were enrolled in EBOVAC-Salone: 12-17 year olds, 4-11 year olds, and 1-3 year olds).

Cohort 1

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be open to subjects who were exposed to Ad26.ZEBOV and/or MVA-BN®-Filo in the EBOVAC-Salone study. The study population will consist of two cohorts: * Cohort 1: subjects who received an Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study. Adults are defined as participants 18 years of age or older at the time of prime vaccination, and children are defined as participants aged 1 to 17 years at the time of prime vaccination. * Cohort 2 (offspring) will consist of infants conceived by a female participant in EBOVAC-Salone during the 3 months following vaccination with Ad26.ZEBOV or during the 28 days following vaccination with MVA-BN®-Filo.

You may qualify if:

  • Must be a participant, or former participant, of the EBOVAC-Salone study, and received Ebola vaccine prime vaccination.
  • or Must be an infant conceived by a female participant of EBOVAC-Salone during the 3-month period following vaccination with Ad26.ZEBOV or the 28 day period following vaccination with MVA-BN®-Filo.
  • Must consent to participate in the EBOVAC-Salone Extension study by signing (or thumbprinting, if illiterate) an ICF, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. If a potential participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study. If the potential participant is under 18 years of age, they and their parent/guardian will be informed about the study and the parent/guardian will be asked to give consent. Children aged 7 years and older will be asked to give positive assent for their participation in the study and the assent procedure must be witnessed by an adult, literate parent/guardian/third party not involved in the conduct of the study, and documented.
  • Must confirm that he/she will return to the study site for each yearly visit.

You may not qualify if:

  • Participants in the EBOVAC-Salone study who were allocated to the control arm receiving the WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine
  • Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study, or unlikely to complete follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EBOVAC Rokupr clinic

Rokupr, Kambia, Sierra Leone

Location

EBOVAC Kambia 1 clinic

Kambia, Sierra Leone

Location

Related Publications (2)

  • Portugal S, Tipton CM, Sohn H, Kone Y, Wang J, Li S, Skinner J, Virtaneva K, Sturdevant DE, Porcella SF, Doumbo OK, Doumbo S, Kayentao K, Ongoiba A, Traore B, Sanz I, Pierce SK, Crompton PD. Malaria-associated atypical memory B cells exhibit markedly reduced B cell receptor signaling and effector function. Elife. 2015 May 8;4:e07218. doi: 10.7554/eLife.07218.

    PMID: 25955968RESULT

  • Ryg-Cornejo V, Ioannidis LJ, Ly A, Chiu CY, Tellier J, Hill DL, Preston SP, Pellegrini M, Yu D, Nutt SL, Kallies A, Hansen DS. Severe Malaria Infections Impair Germinal Center Responses by Inhibiting T Follicular Helper Cell Differentiation. Cell Rep. 2016 Jan 5;14(1):68-81. doi: 10.1016/j.celrep.2015.12.006. Epub 2015 Dec 24.

    PMID: 26725120RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Deborah Watson-Jones, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Bailah Leigh, MD

    University of Sierra Leone

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

July 22, 2019

Primary Completion

June 28, 2022

Study Completion

July 14, 2022

Last Updated

February 8, 2023

Record last verified: 2022-02

Locations

SI(2)