Ebola Virus Disease Clinical Trial
Official title:
A Cohort Study to Evaluate the Long-term Safety and Immunogenicity of the Candidate Ebola Vaccines Ad26.ZEBOV and MVA-BN®-Filo in Adults and Children
NCT number | NCT03820739 |
Other study ID # | VAC52150EBL3005 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 22, 2019 |
Est. completion date | July 14, 2022 |
Verified date | February 2022 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 653 |
Est. completion date | July 14, 2022 |
Est. primary completion date | June 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year and older |
Eligibility | Inclusion Criteria: 1. 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. 2. 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. 3. Must confirm that he/she will return to the study site for each yearly visit. Exclusion Criteria: 1. 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 2. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study, or unlikely to complete follow up |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | EBOVAC Kambia 1 clinic | Kambia | |
Sierra Leone | EBOVAC Rokupr clinic | Rokupr | Kambia |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Institut National de la Santé Et de la Recherche Médicale, France, Janssen Vaccines & Prevention B.V., Universiteit Antwerpen, University of Sierra Leone |
Sierra Leone,
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 redu — View Citation
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. 201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Neutralising antibody responses directed against EBOV GP as measured by a pseudovirion neutralisation assay (psVNA) | psVNA: pseudovirion neutralising antibody reactivity against the EBOV GP defined as the serum titre that is able to inhibit viral infection by 50% (IC50 titer). | At years 2, 3 and 4 post-prime in children and years 3, 4 and 5 post-prime in adults | |
Secondary | Effect of previous infection with malaria, determined using validated ELISA and bead based assays, on the persistence of the humoral immune response to vaccination. | Serum concentration of malaria specific antibodies, determined using validated ELISA and bead based assays. The bead based assays will allow the inclusion of antigens associated with short term humoral immune responses and thus assessment of intra study exposure to malaria. | Up to approximately 5 years in adults and 4 years in children from prime vaccination |
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