Ebola Virus DiseaseNCT03820739
EBOVAC-Salone Extension
An observational study of Ebola Virus Disease, run by London School of Hygiene and Tropical Medicine at 2 sites in Sierra Leone.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Follow-up and Blood sample collection
- Type of treatment
- Vaccines
- How many people
- 653 participants
- Where
- 2 sitesSierra Leone
- Study dates
- 22 Jul 2019to 14 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sierra Leone2 sites
EBOVAC Kambia 1 clinic
Kambia
EBOVAC Rokupr clinic
Rokupr, Kambia
About this study
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
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.
Read the detailed description
The VAC52150EBL3005 (EBOVAC-Salone Extension) is 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.
Ad26.ZEBOV consists of the Janssen Vaccines \& Prevention B.V. adenovirus serotype 26 (Ad26) vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant.
MVA-BN®-Filo consists of the Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus.
These candidate Ebola vaccines are being evaluated in phase 1, 2 and 3 clinical studies, in different heterologous prime-boost regimens, in which one study vaccine is used to prime a filovirus-specific immune response and the other study vaccine is used to boost the humoral immune responses. The VAC52150EBL3001 study (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494) taking place in Kambia District, Northern Sierra Leone, is a phase 3 trial with an open-label Stage 1 followed by a randomised double-blind controlled Stage 2. In Stage 1, 43 adults (aged 18 years or older) received Ad26.ZEBOV as prime followed by MVA-BN®-Filo boost vaccination at day 57. In Stage 2, approximately 400 adults and 576 children (aged 1 to 17 years - divided into three age groups; 12 to 17 years, 4 to 11 years, and 1 to 3 years), have been randomised to receive a vaccine regimen of Ad26.ZEBOV as prime and MVA-BN®-Filo as boost at day 57, or control vaccination for both prime and boost vaccination. The control used is a World Health Organisation (WHO)-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine. EBOVAC-Salone Extension has been designed to extend the total follow-up period of participants exposed to the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in the EBOVAC-Salone study, and to follow-up infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC-Salone.
STUDY OBJECTIVES
This study aims to evaluate the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo administered to adults and children in EBOVAC-Salone and the long-term safety of infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV and the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC-Salone.
Primary Objectives
- To assess the long-term safety of Ad26.ZEBOV at a dose of 5x1010 viral particles and MVA-BN®-Filo at a dose of 1x108 TCID50 (50% Tissue Culture Infective Dose) in African adults (for 5 years) and children (for 4 years).
- To assess binding antibody responses against EBOV GP, up to 5 years post-prime in adults and 4 years post-prime in children using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
- To assess safety, up to their fifth birthday, in infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo.
Secondary Objectives
- To assess 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, depending on sample and assay availability.
- To evaluate the 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 5 years post-prime in adults and 4 years post-prime in children. 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.
OVERVIEW OF STUDY DESIGN
This 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 EBOVAC-Salone trial. Cohort 1 will consist of participants who received an Ebola vaccine during the EBOVAC-Salone study. Adults (defined as participants 18 years of age or older at the time of the EBOVAC-Salone prime vaccination) will be followed up annually for 5 years from receipt of prime vaccination and children (defined as participants aged 1 to 17 years at the time of the EBOVAC-Salone prime vaccination) will be followed up annually for 4 years from the receipt 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. Offspring will be followed annually for occurrence of serious adverse events (SAEs) until their fifth birthday.
No investigational vaccine will be administered during EBOVAC-Salone Extension. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit.
No study-related activities will be performed until a subject, or parent/guardian has given informed consent for their, or their child's, participation in the study. For cohort 1, enrolment into EBOVAC-Salone Extension will occur at the subject's final study visit in EBOVAC-Salone once the informed consent form (ICF) has been signed. If a subject has already completed their final study visit in EBOVAC-Salone, enrolment and baseline information will be collected at the time the participant signs the EBOVAC-Salone Extension ICF. Information from the participant's final EBOVAC-Salone study visit up to the moment of enrolment into this study will be captured retrospectively. For cohort 2, enrolment will occur once the subject's parent/guardian has signed the EBOVAC-Salone Extension ICF. Baseline information and information from birth up to the moment of enrolment into this study will be collected at the time the ICF is signed.
Study visits will take place as follows:
Cohort 1: Once yearly, on the anniversary of their prime vaccination (± 1 month), cohort 1 participants will attend the study clinic for collection of information on any SAEs since their previous visit. In a subsample of participants, blood sampling for serology assays will also be collected at each study visit.
Cohort 2: Once yearly, on their birthday (± 1 month), cohort 2 participants (offspring) will be seen at the study clinic) for collection of information on any SAEs they experienced since their previous study visit.
Between clinic visits, reminder phone calls and/or home visits will be used for retention purposes, if needed.
SUBJECT POPULATION
Cohort 1: subjects who received Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study.
Cohort 2: any infant conceived by a female EBOVAC-Salone participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC- Salone are also eligible for this study.
DOSAGE AND ADMINISTRATION
No investigational vaccine will be administered during this study.
SAFETY EVALUATIONS
All SAEs occurring from the final EBOVAC-Salone study visit (or from birth for eligible offspring) will be collected annually as indicated in the Time and Events Schedules.
IMMUNOGENICITY EVALUATIONS
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). Some of the blood collected will also be used to determine previous exposure to malaria using validated ELISA and bead based assay. The immune response to malaria will be considered when evaluating the persistence of antibody response induced by the Ebola vaccines.
OTHER CLINICAL ASSESSMENTS
In both cohort 1 and cohort 2, a physical examination including vital signs will be conducted at the first study visit and at yearly visits. In cohort 2, growth measurements will also be collected. In cohort 1, a haematology assessment will be conducted in the subsample providing immunogenicity blood samples.
STATISTICAL METHODS
The primary analysis will be done when all participants have completed their final study visit or discontinued. This analysis will include all available data up to this point. No interim analyses are planned. There are no formal hypotheses tests planned for the safety data. The primary endpoint for long term safety of Ad26.ZEBOV and MVA-BN®-Filo is the occurrence of SAEs in the total vaccine cohort during the follow up period of up to 5 years (in adults) or 4 years (in children), and separately in infants in cohort 2. The primary analysis for immunogenicity will involve assessing humoral immune responses to Ad26.ZEBOV or MVA-BN®-Filo using a longitudinal design in children and adults vaccinated with Ad26.ZEBOV or MVA-BN®-Filo (cohort 1).
- Conditions
- Ebola Virus Disease
- Being tested
- Follow-up, Blood sample collection
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
No investigational vaccine will be administered during this study
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Follow-up; Other: 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. Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: From birth to their fifth birthday
Secondary outcomes (2)
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).
Measured: 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.
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.
Measured: Up to approximately 5 years in adults and 4 years in children from prime vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start22 Jul 2019
- Primary completion28 Jun 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sierra Leone, Janssen Vaccines & Prevention B.V., Institut National de la Santé Et de la Recherche Médicale, France, Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Deborah Watson-Jones, PhD, Principal investigator, London School of Hygiene and Tropical MedicineBailah Leigh, MD, Principal investigator, University of Sierra Leone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820739
- Sponsor's protocol ID
- VAC52150EBL3005
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25955968Ryg-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.
PubMed 26725120
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03820739
- Acronym / sponsor ID
- VAC52150EBL3005
- Conditions
- Ebola Virus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Sierra Leone, Janssen Vaccines & Prevention B.V., Institut National de la Santé Et de la Recherche Médicale, France, Universiteit Antwerpen
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The VAC52150EBL3005 (EBOVAC-Salone Extension) is 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.
Ad26.ZEBOV consists of the Janssen Vaccines \& Prevention B.V. adenovirus serotype 26 (Ad26) vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant.
MVA-BN®-Filo consists of the Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus and Marburg virus and the nucleoprotein of Tai Forest virus.
These candidate Ebola vaccines are being evaluated in phase 1, 2 and 3 clinical studies, in different heterologous prime-boost regimens, in which one study vaccine is used to prime a filovirus-specific immune response and the other study vaccine is used to boost the humoral immune responses. The VAC52150EBL3001 study (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494) taking place in Kambia District, Northern Sierra Leone, is a phase 3 trial with an open-label Stage 1 followed by a randomised double-blind controlled Stage 2. In Stage 1, 43 adults (aged 18 years or older) received Ad26.ZEBOV as prime followed by MVA-BN®-Filo boost vaccination at day 57. In Stage 2, approximately 400 adults and 576 children (aged 1 to 17 years - divided into three age groups; 12 to 17 years, 4 to 11 years, and 1 to 3 years), have been randomised to receive a vaccine regimen of Ad26.ZEBOV as prime and MVA-BN®-Filo as boost at day 57, or control vaccination for both prime and boost vaccination. The control used is a World Health Organisation (WHO)-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine. EBOVAC-Salone Extension has been designed to extend the total follow-up period of participants exposed to the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in the EBOVAC-Salone study, and to follow-up infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC-Salone.
STUDY OBJECTIVES
This study aims to evaluate the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo administered to adults and children in EBOVAC-Salone and the long-term safety of infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV and the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC-Salone.
Primary Objectives
- To assess the long-term safety of Ad26.ZEBOV at a dose of 5x1010 viral particles and MVA-BN®-Filo at a dose of 1x108 TCID50 (50% Tissue Culture Infective Dose) in African adults (for 5 years) and children (for 4 years).
- To assess binding antibody responses against EBOV GP, up to 5 years post-prime in adults and 4 years post-prime in children using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
- To assess safety, up to their fifth birthday, in infants conceived by a female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo.
Secondary Objectives
- To assess 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, depending on sample and assay availability.
- To evaluate the 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 5 years post-prime in adults and 4 years post-prime in children. 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.
OVERVIEW OF STUDY DESIGN
This 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 EBOVAC-Salone trial. Cohort 1 will consist of participants who received an Ebola vaccine during the EBOVAC-Salone study. Adults (defined as participants 18 years of age or older at the time of the EBOVAC-Salone prime vaccination) will be followed up annually for 5 years from receipt of prime vaccination and children (defined as participants aged 1 to 17 years at the time of the EBOVAC-Salone prime vaccination) will be followed up annually for 4 years from the receipt 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. Offspring will be followed annually for occurrence of serious adverse events (SAEs) until their fifth birthday.
No investigational vaccine will be administered during EBOVAC-Salone Extension. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit.
No study-related activities will be performed until a subject, or parent/guardian has given informed consent for their, or their child's, participation in the study. For cohort 1, enrolment into EBOVAC-Salone Extension will occur at the subject's final study visit in EBOVAC-Salone once the informed consent form (ICF) has been signed. If a subject has already completed their final study visit in EBOVAC-Salone, enrolment and baseline information will be collected at the time the participant signs the EBOVAC-Salone Extension ICF. Information from the participant's final EBOVAC-Salone study visit up to the moment of enrolment into this study will be captured retrospectively. For cohort 2, enrolment will occur once the subject's parent/guardian has signed the EBOVAC-Salone Extension ICF. Baseline information and information from birth up to the moment of enrolment into this study will be collected at the time the ICF is signed.
Study visits will take place as follows:
Cohort 1: Once yearly, on the anniversary of their prime vaccination (± 1 month), cohort 1 participants will attend the study clinic for collection of information on any SAEs since their previous visit. In a subsample of participants, blood sampling for serology assays will also be collected at each study visit.
Cohort 2: Once yearly, on their birthday (± 1 month), cohort 2 participants (offspring) will be seen at the study clinic) for collection of information on any SAEs they experienced since their previous study visit.
Between clinic visits, reminder phone calls and/or home visits will be used for retention purposes, if needed.
SUBJECT POPULATION
Cohort 1: subjects who received Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study.
Cohort 2: any infant conceived by a female EBOVAC-Salone participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo in EBOVAC- Salone are also eligible for this study.
DOSAGE AND ADMINISTRATION
No investigational vaccine will be administered during this study.
SAFETY EVALUATIONS
All SAEs occurring from the final EBOVAC-Salone study visit (or from birth for eligible offspring) will be collected annually as indicated in the Time and Events Schedules.
IMMUNOGENICITY EVALUATIONS
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). Some of the blood collected will also be used to determine previous exposure to malaria using validated ELISA and bead based assay. The immune response to malaria will be considered when evaluating the persistence of antibody response induced by the Ebola vaccines.
OTHER CLINICAL ASSESSMENTS
In both cohort 1 and cohort 2, a physical examination including vital signs will be conducted at the first study visit and at yearly visits. In cohort 2, growth measurements will also be collected. In cohort 1, a haematology assessment will be conducted in the subsample providing immunogenicity blood samples.
STATISTICAL METHODS
The primary analysis will be done when all participants have completed their final study visit or discontinued. This analysis will include all available data up to this point. No interim analyses are planned. There are no formal hypotheses tests planned for the safety data. The primary endpoint for long term safety of Ad26.ZEBOV and MVA-BN®-Filo is the occurrence of SAEs in the total vaccine cohort during the follow up period of up to 5 years (in adults) or 4 years (in children), and separately in infants in cohort 2. The primary analysis for immunogenicity will involve assessing humoral immune responses to Ad26.ZEBOV or MVA-BN®-Filo using a longitudinal design in children and adults vaccinated with Ad26.ZEBOV or MVA-BN®-Filo (cohort 1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Follow-up, Other: Blood sample collectionSubjects 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. |
| Cohort 2 (offspring) | – | Other: Follow-upInfants 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-upNo investigational vaccine will be administered during this study | Other | Cohort 1, Cohort 2 (offspring) |
| Blood sample collectionBlood 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). | Other | Cohort 1 |
Primary outcome
Number of Serious Adverse Events in subjects who received an Ebola vaccine prime vaccination in the EBOVAC-Salone trial.
Time frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination
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.
Binding antibody responses against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
Time frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination
Serum Concentration of Antibodies Binding to EBOV GP measured by Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).
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.
Time frame: From birth to their fifth birthday
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.
2 secondary outcomes
Neutralising antibody responses directed against EBOV GP as measured by a pseudovirion neutralisation assay (psVNA)
Time frame: 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.
Time frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 25955968Portugal 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.
- Results publication: PubMed 26725120Ryg-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.
- WHO. Ebola virus disease - key facts.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Watson-Jones, PhD principal investigator
London School of Hygiene and Tropical Medicine
Bailah Leigh, MD principal investigator
University of Sierra Leone
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Virus Disease, run by London School of Hygiene and Tropical Medicine at 2 sites in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events in subjects who received an Ebola vaccine prime vaccination in the EBOVAC-Salone trial. (time frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.