Ebola Virus DiseasePhase 2NCT04711356
Ad26.ZEBOV Booster in Children Previously Vaccinated With Ad26.ZEBOV and MVA-BN-Filo (EBOVAC Booster Study)
A Phase 2 study testing Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection in people with Ebola Virus Disease, run by London School of Hygiene and Tropical Medicine at 1 site in Sierra Leone.
Trial summary
This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSierra Leone
- Study dates
- 8 Jul 2021to 31 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child must be enrolled in the VAC52150EBL3005 (EBOVAC-Salone Extension) study but not in the immunogenicity subset of EBOVAC-Salone Extension study.
- Child must be a former participant in the VAC52150EBL3001 (EBOVAC-Salone) trial, and have received Ad26.ZEBOV (dose 1) vaccination followed by the MVA-BN-Filo (dose 2) vaccination within the EBOVAC- Salone trial window for dose 2 vaccination.
- Child must have been aged 1 to 11 years old at the time of dose 1 vaccination in the EBOVAC-Salone trial.
- The parent/guardian must consent for their child to participate in the VAC52150EBL2011 study. Children aged 7 years and older will be asked to give positive assent for their participation in the study.
- The parent/guardian is willing/able to ensure that their child adheres to the prohibitions and restrictions specified in this protocol.
- Child must be healthy in the investigator's clinical judgement (and the parent/guardian's judgement) on the basis of medical history, physical examination, vital signs, and a haematological assessment (i.e. full blood count) performed at screening. Subjects must meet the following haematology parameters within 28 days before Day 1:
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- Haemoglobin ≥8.0 g/dL for children aged 1 to <5 years, ≥9g/dL for children aged 5 or older
- Platelet count ≥100 x 10^9/L
- White blood cell count ≥5.0 x 10^9/L
- Adolescent girls who have started their menstrual periods and/or are ≥12 years of age at the time of screening, must have a negative urine β-hCG pregnancy test at screening and immediately prior to the booster vaccination on Day 1.
- The parent/guardian is available and willing to have their infant participate for the duration of the study visits.
- The parent/guardian must have a means to be contacted.
- The parent/guardian must pass the Test of Understanding (TOU)
Who cannot join
- Participants in the EBOVAC-Salone trial who were allocated to the control arm receiving the WHO- prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
- Participants in the EBOVAC-Salone trial who were age 12 years and older at the time of dose 1 vaccination.
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine, e.g., polysorbate 80, ethylenediaminetetraacetic acid or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin).
- Presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38C on Day 1. Participants with such symptoms will be excluded from enrolment at that time but may be rescheduled for enrolment at a later date within the screening window.
- Clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
- Adolescent girls who are known to be pregnant or breastfeeding at screening.
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- Received a blood transfusion or other blood products within 8 weeks of vaccination day.
- Children who have been vaccinated with live-attenuated vaccines within 30 days before the study vaccination, and with inactivated vaccine within 15 days before the study vaccination.
- Children who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the vaccination and observation.
- Any other finding which in the opinion of the investigator or other delegated individual would increase the risk of an adverse outcome from participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate the Safety and Immunogenicity of an Ad26.ZEBOV Booster Dose in Children Previously Vaccinated With the Ad26.ZEBOV and MVA-BN-Filo Vaccine Regimen
This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later.
Read the detailed description
RATIONALE:
Over 600 children have received the adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV), modified Vaccinia Ankara Bavarian Nordic vector expressing multiple filovirus proteins (MVA- BN-Filo) Ebola vaccine regimen in the EBL2002 and EBL3001 clinical trials. The vaccine regimen was well tolerated and highly immunogenic in children; however, the durability of vaccine-induced immune responses is not known. In adults previously vaccinated with the Ad26.ZEBOV and MVA-BN-Filo regimen, a booster vaccination with Ad26.ZEBOV was safe and induced a strong anamnestic response within seven days of the booster vaccination. It is important to establish if a booster dose of Ad26.ZEBOV is safe and immunogenic also in children, as this can guide the clinical use of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in this age group. For example, it could support the strategy of boosting immunised children at the start of an Ebola outbreak.
STUDY OBJECTIVES AND HYPOTHESIS:
This study aims to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in healthy children who were previously (>2 years) vaccinated with the Ad26.ZEBOV (dose 1) followed by MVA-BN-Filo (dose 2) 56 days later, by monitoring adverse events (AEs) following the booster vaccination and by assessing binding antibody responses using the Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA).
Primary Objectives:
- To assess the safety and tolerability of a booster dose of Ad26.ZEBOV at a dose of 5x10^10 viral particles (vp) in children previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with a 56-day interval. Safety and tolerability will be assessed by measuring:
- Incidence of solicited local (at the administration site) and systemic adverse events as assessed on the day of booster vaccination and by diary card for 7 days after booster vaccination.
- Incidence of unsolicited adverse events from the day of the booster vaccination to 28 days post booster vaccination.
- To assess vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP), as measured by FANG ELISA (EU/ml), at 7 and 21 days following a booster dose of Ad26.ZEBOV at a dose of 5x10^10 vp in children previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with a 56-day interval.
Exploratory Objectives
- To assess neutralising antibody responses directed against the Ad26 vector before booster vaccination as measured by a virus neutralization assay (VNA).
Hypothesis: as this study is designed to provide descriptive information regarding safety and immunogenicity without formal treatment comparisons, no formal statistical hypothesis testing is planned.
OVERVIEW OF THE STUDY:
This is an open-label study evaluating the immune response to a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later. Only subjects who received the Ad26.ZEBOV and MVA-BN-Filo regimen during their participation in the VAC52150EBL3001 (EBOVAC-Salone) vaccine trial (ClinicalTrials.gov Identifier: NCT02509494), are eligible for enrolment in this study. Participants will be recruited in two age groups: children aged 4-11 years at the time of dose 1 vaccination and children aged 1-3 years at the time of dose 1 vaccination in the EBOVAC-Salone trial. Approximately 25 subjects will be enrolled in each of these two age groups. Parents/guardians will be asked to consent for the participation of their children in the study. Children aged 7 years and older at the time of enrolment in this study will be asked to give positive assent for their participation. Participants will be followed up to 28 days after their booster vaccination. The study will be conducted in Kambia, Sierra Leone.
Study Population: potential participants must be healthy children (based on physical examination, medical history, a haematological assessment and clinical judgment) who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the EBOVAC-Salone trial and were aged ≥1 to ≤11 years at the time of dose 1 vaccination. They must also be enrolled in the long-term follow-up study to the EBOVAC-Salone trial, VAC52150EBL3005 (EBOVAC-Salone Extension study, ClinicalTrials.gov Identifier: NCT03820739) but not in the immunogenicity subset.
Dosage and administration: a single dose of Ad26.ZEBOV at a dose of 5x10^10 vp administered intramuscularly.
Safety evaluations: solicited local (at the administration site) and systemic AEs will be assessed on the day of vaccination and using a diary for a period of 7 days following the booster vaccination. Unsolicited AEs will be tracked for 28 days following booster vaccination, while serious adverse events will be tracked for the duration of the study.
Immunogenicity evaluations: blood will be drawn for assessments of immune responses at 7 and 21 days post booster vaccination.
STATISTICAL METHODS:
The primary analysis will be done when all subjects have completed their 28-day post-booster visit or discontinued earlier. This analysis will include all available data up to this point.
Sample Size Determination: the sample size is a convenience sample and is not based on formal hypothesis testing considerations.
Safety analysis: no formal statistical testing of safety data is planned. Safety data will be analysed descriptively by age group, 1-3 years and 4-11 years (age the participant was when they received dose 1 vaccination in the EBOVAC-Salone trial).
Immunogenicity analysis: no formal hypothesis on immunogenicity will be tested. Descriptive statistics (i.e. geometric mean and 95% confidence interval, as appropriate) will be calculated for continuous immunologic parameters at all available time points. Graphical representations of immunologic parameters will be made as applicable.
Frequency tabulations will be calculated for discrete (qualitative) immunologic parameters (i.e. responder rate), as applicable. Responders rate defined as >2.5-time increase over baseline value (or lower limit of quantitation [LLOQ]) pre-dose 1 vaccination in the EBOVAC-Salone trial, will be calculated depending on availability of sample results from the EBOVAC-Salone trial.
- Conditions
- Ebola Virus Disease
- Being tested
- Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection
- Keywords
- Ad26.ZEBOV, booster vaccination, children
- 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.
Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injectionDrug
Ad26.ZEBOV is a monovalent, replication-incompetent adenovirus serotype 26-based vector that expresses the full-length Ebola virus Mayinga glycoprotein
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | All study participants will receive an Ad26.ZEBOV vaccine at a dose of 5x10^10 vp given via IM injection Receives: Drug: Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local (at the Administration Site) Adverse Events
Number and percentage of participants with at least one solicited local adverse event (i.e. pain, erythema, pruritus and swelling)
Measured: From the booster vaccination to 7 days post booster
Number of Participants With Solicited Systemic Adverse Events
Number and percentage of participants with at least one solicited systemic adverse event (i.e. arthralgia, chills, fatigue, headache, myalgia, nausea and pyrexia)
Measured: From the booster vaccination to 7 days post booster
Number of Participants With Unsolicited Adverse Events
Number and percentage of participants with at least one unsolicited adverse event
Measured: From the booster vaccination to 28 days post booster
Number of Participants With Serious Adverse Events
Number and percentage of participants with serious adverse events
Measured: From the booster vaccination to 28 days post booster
Pre-booster Baseline Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Measured: day 1 before booster administration
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Measured: At 7 days post booster
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Measured: At 21 days post booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start8 Jul 2021
- Primary completion17 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a single dose of Ad26.ZEBOV at a dose of 5x10\^10 viral particles (vp) administered intramuscularly.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative, University of Sierra Leone
- 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
- NCT04711356
- Sponsor's protocol ID
- VAC52150EBL2011
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2020
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical trial results will be published in an open access, peer-reviewed journal, which will include the study protocol. A summary of the study results will be included within the trial registration record in PACTR and ClinicalTrials.gov Following publication of the primary and exploratory objectives as detailed in the protocol, individual de-identified participants' data and a data dictionary will be made available upon request via the London School of Hygiene \& Tropical Medicine research data repository, LSHTM Data Compass at http://datacompass.lshtm.ac.uk. Requests with a defined analysis plan can be sent via LSHTM Data Compass.
Publications
Manno D, Bangura A, Baiden F, Kamara AB, Ayieko P, Kallon J, Foster J, Conteh M, Connor NE, Koroma B, Njie Y, Borboh P, Keshinro B, Lawal BJ, Kroma MT, Otieno GT, Deen AT, Choi EM, Balami AD, Gaddah A, McLean C, Luhn K, Adetola HH, Deen GF, Samai M, Lowe B, Robinson C, Leigh B, Greenwood B, Watson-Jones D. Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial. Lancet Infect Dis. 2023 Mar;23(3):352-360. doi: 10.1016/S1473-3099(22)00594-1. Epub 2022 Oct 20.
PubMed 36273490
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Safety and Immunogenicity of an Ad26.ZEBOV Booster Dose in Children Previously Vaccinated With the Ad26.ZEBOV and MVA-BN-Filo Vaccine Regimen
- ClinicalTrials.gov ID
- NCT04711356
- Acronym / sponsor ID
- VAC52150EBL2011
- Conditions
- Ebola Virus Disease
- Keywords
- Ad26.ZEBOV, booster vaccination, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative, University of Sierra Leone
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study evaluating the safety and immunogenicity of a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later.
Detailed description
RATIONALE:
Over 600 children have received the adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV), modified Vaccinia Ankara Bavarian Nordic vector expressing multiple filovirus proteins (MVA- BN-Filo) Ebola vaccine regimen in the EBL2002 and EBL3001 clinical trials. The vaccine regimen was well tolerated and highly immunogenic in children; however, the durability of vaccine-induced immune responses is not known. In adults previously vaccinated with the Ad26.ZEBOV and MVA-BN-Filo regimen, a booster vaccination with Ad26.ZEBOV was safe and induced a strong anamnestic response within seven days of the booster vaccination. It is important to establish if a booster dose of Ad26.ZEBOV is safe and immunogenic also in children, as this can guide the clinical use of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in this age group. For example, it could support the strategy of boosting immunised children at the start of an Ebola outbreak.
STUDY OBJECTIVES AND HYPOTHESIS:
This study aims to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in healthy children who were previously (>2 years) vaccinated with the Ad26.ZEBOV (dose 1) followed by MVA-BN-Filo (dose 2) 56 days later, by monitoring adverse events (AEs) following the booster vaccination and by assessing binding antibody responses using the Filovirus Animal Non-Clinical Group (FANG) Enzyme-Linked Immunosorbent Assay (ELISA).
Primary Objectives:
- To assess the safety and tolerability of a booster dose of Ad26.ZEBOV at a dose of 5x10^10 viral particles (vp) in children previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with a 56-day interval. Safety and tolerability will be assessed by measuring:
- Incidence of solicited local (at the administration site) and systemic adverse events as assessed on the day of booster vaccination and by diary card for 7 days after booster vaccination.
- Incidence of unsolicited adverse events from the day of the booster vaccination to 28 days post booster vaccination.
- To assess vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP), as measured by FANG ELISA (EU/ml), at 7 and 21 days following a booster dose of Ad26.ZEBOV at a dose of 5x10^10 vp in children previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen with a 56-day interval.
Exploratory Objectives
- To assess neutralising antibody responses directed against the Ad26 vector before booster vaccination as measured by a virus neutralization assay (VNA).
Hypothesis: as this study is designed to provide descriptive information regarding safety and immunogenicity without formal treatment comparisons, no formal statistical hypothesis testing is planned.
OVERVIEW OF THE STUDY:
This is an open-label study evaluating the immune response to a booster dose of Ad26.ZEBOV administered to children who were previously vaccinated with Ad26.ZEBOV followed by MVA-BN-Filo 56 days later. Only subjects who received the Ad26.ZEBOV and MVA-BN-Filo regimen during their participation in the VAC52150EBL3001 (EBOVAC-Salone) vaccine trial (ClinicalTrials.gov Identifier: NCT02509494), are eligible for enrolment in this study. Participants will be recruited in two age groups: children aged 4-11 years at the time of dose 1 vaccination and children aged 1-3 years at the time of dose 1 vaccination in the EBOVAC-Salone trial. Approximately 25 subjects will be enrolled in each of these two age groups. Parents/guardians will be asked to consent for the participation of their children in the study. Children aged 7 years and older at the time of enrolment in this study will be asked to give positive assent for their participation. Participants will be followed up to 28 days after their booster vaccination. The study will be conducted in Kambia, Sierra Leone.
Study Population: potential participants must be healthy children (based on physical examination, medical history, a haematological assessment and clinical judgment) who received the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen in the EBOVAC-Salone trial and were aged ≥1 to ≤11 years at the time of dose 1 vaccination. They must also be enrolled in the long-term follow-up study to the EBOVAC-Salone trial, VAC52150EBL3005 (EBOVAC-Salone Extension study, ClinicalTrials.gov Identifier: NCT03820739) but not in the immunogenicity subset.
Dosage and administration: a single dose of Ad26.ZEBOV at a dose of 5x10^10 vp administered intramuscularly.
Safety evaluations: solicited local (at the administration site) and systemic AEs will be assessed on the day of vaccination and using a diary for a period of 7 days following the booster vaccination. Unsolicited AEs will be tracked for 28 days following booster vaccination, while serious adverse events will be tracked for the duration of the study.
Immunogenicity evaluations: blood will be drawn for assessments of immune responses at 7 and 21 days post booster vaccination.
STATISTICAL METHODS:
The primary analysis will be done when all subjects have completed their 28-day post-booster visit or discontinued earlier. This analysis will include all available data up to this point.
Sample Size Determination: the sample size is a convenience sample and is not based on formal hypothesis testing considerations.
Safety analysis: no formal statistical testing of safety data is planned. Safety data will be analysed descriptively by age group, 1-3 years and 4-11 years (age the participant was when they received dose 1 vaccination in the EBOVAC-Salone trial).
Immunogenicity analysis: no formal hypothesis on immunogenicity will be tested. Descriptive statistics (i.e. geometric mean and 95% confidence interval, as appropriate) will be calculated for continuous immunologic parameters at all available time points. Graphical representations of immunologic parameters will be made as applicable.
Frequency tabulations will be calculated for discrete (qualitative) immunologic parameters (i.e. responder rate), as applicable. Responders rate defined as >2.5-time increase over baseline value (or lower limit of quantitation [LLOQ]) pre-dose 1 vaccination in the EBOVAC-Salone trial, will be calculated depending on availability of sample results from the EBOVAC-Salone trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a single dose of Ad26.ZEBOV at a dose of 5x10^10 viral particles (vp) administered intramuscularly.
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Drug: Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injectionAll study participants will receive an Ad26.ZEBOV vaccine at a dose of 5x10^10 vp given via IM injection |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Child must be enrolled in the VAC52150EBL3005 (EBOVAC-Salone Extension) study but not in the immunogenicity subset of EBOVAC-Salone Extension study.
- Child must be a former participant in the VAC52150EBL3001 (EBOVAC-Salone) trial, and have received Ad26.ZEBOV (dose 1) vaccination followed by the MVA-BN-Filo (dose 2) vaccination within the EBOVAC- Salone trial window for dose 2 vaccination.
- Child must have been aged 1 to 11 years old at the time of dose 1 vaccination in the EBOVAC-Salone trial.
- The parent/guardian must consent for their child to participate in the VAC52150EBL2011 study. Children aged 7 years and older will be asked to give positive assent for their participation in the study.
- The parent/guardian is willing/able to ensure that their child adheres to the prohibitions and restrictions specified in this protocol.
Key exclusion criteria (10 listed)
- Participants in the EBOVAC-Salone trial who were allocated to the control arm receiving the WHO- prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
- Participants in the EBOVAC-Salone trial who were age 12 years and older at the time of dose 1 vaccination.
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine, e.g., polysorbate 80, ethylenediaminetetraacetic acid or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin).
- Presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38C on Day 1. Participants with such symptoms will be excluded from enrolment at that time but may be rescheduled for enrolment at a later date within the screening window.
- Clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
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 |
|---|---|---|
| Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injectionAd26.ZEBOV is a monovalent, replication-incompetent adenovirus serotype 26-based vector that expresses the full-length Ebola virus Mayinga glycoprotein | Drug | Study Intervention |
Primary outcome
Number of Participants With Solicited Local (at the Administration Site) Adverse Events
Time frame: From the booster vaccination to 7 days post booster
Number and percentage of participants with at least one solicited local adverse event (i.e. pain, erythema, pruritus and swelling)
Number of Participants With Solicited Systemic Adverse Events
Time frame: From the booster vaccination to 7 days post booster
Number and percentage of participants with at least one solicited systemic adverse event (i.e. arthralgia, chills, fatigue, headache, myalgia, nausea and pyrexia)
Number of Participants With Unsolicited Adverse Events
Time frame: From the booster vaccination to 28 days post booster
Number and percentage of participants with at least one unsolicited adverse event
Number of Participants With Serious Adverse Events
Time frame: From the booster vaccination to 28 days post booster
Number and percentage of participants with serious adverse events
Pre-booster Baseline Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
Time frame: day 1 before booster administration
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
Time frame: At 7 days post booster
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Vaccine-induced Humoral Immune Responses to the Ebola Virus Glycoprotein (EBOV GP)
Time frame: At 21 days post booster
EBOV GP antibody geometric mean concentration measured by FANG ELISA in Elisa Units (EU) per millilitre
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36273490Manno D, Bangura A, Baiden F, Kamara AB, Ayieko P, Kallon J, Foster J, Conteh M, Connor NE, Koroma B, Njie Y, Borboh P, Keshinro B, Lawal BJ, Kroma MT, Otieno GT, Deen AT, Choi EM, Balami AD, Gaddah A, McLean C, Luhn K, Adetola HH, Deen GF, Samai M, Lowe B, Robinson C, Leigh B, Greenwood B, Watson-Jones D. Safety and immunogenicity of an Ad26.ZEBOV booster dose in children previously vaccinated with the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen: an open-label, non-randomised, phase 2 trial. Lancet Infect Dis. 2023 Mar;23(3):352-360. doi: 10.1016/S1473-3099(22)00594-1. Epub 2022 Oct 20.
- Individual participant dataSharing planned: Yes. The clinical trial results will be published in an open access, peer-reviewed journal, which will include the study protocol. A summary of the study results will be included within the trial registration record in PACTR and ClinicalTrials.gov Following publication of the primary and exploratory objectives as detailed in the protocol, individual de-identified participants' data and a data dictionary will be made available upon request via the London School of Hygiene \& Tropical Medicine research data repository, LSHTM Data Compass at http://datacompass.lshtm.ac.uk. Requests with a defined analysis plan can be sent via LSHTM Data Compass.
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Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 4
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
Ebola, Bundibugyo Virus Disease (BVD)
Not yet recruitingPhase 2/3
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 1
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
Sudan Virus Disease
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection in people with Ebola Virus Disease, run by London School of Hygiene and Tropical Medicine at 1 site 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 13 inclusion and 10 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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Solicited Local (at the Administration Site) Adverse Events (time frame: From the booster vaccination to 7 days post booster). The study lists 7 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 NCT04711356, which also lists 1 linked publication.
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 13 Dec 2023.