Virus DiseasesPhase 2NCT05284097
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
A Phase 2 study testing Ad26.ZEBOV, MVA-BN-Filo in people with Virus Diseases and Hemorrhagic Fever, Ebola, run by London School of Hygiene and Tropical Medicine at 1 site in Sierra Leone.
Trial summary
This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, Hemorrhagic Fever, Ebola, Infections
- What is being tested?
- Ad26.ZEBOV, MVA-BN-Filo
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSierra Leone
- Study dates
- 19 Sep 2022to 31 Oct 2024
- Phase
- Phase 2
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must have been enrolled in the control arm and received at least the first vaccination (Dose 1) in EBOVAC-Salone.
- Must consent to participate, or their parent/guardian must consent for their child to participate, in the VAC52150EBL2012 study.Children aged 7 years and older will be asked to give positive assent for their participation in the study.
- Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol, or the parent/guardian must be willing/able to ensure that their child adheres to the prohibitions and restrictions specified in the protocol
- 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.
- Female subjects of childbearing potential, who have started their menstrual periods and/or are ≥12 years of age at the time of screening must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before vaccination until the end of the study, with a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test at screening and immediately prior to the vaccination, which shall occur no earlier than 14 days after the screening visit.
- Must be willing to participate for the duration of the study visits, or the parent/guardian must be available and willing to have their child participate for the duration of the study visits.
- Must have, or the parent/guardian must have, the means to be contacted.
- Must pass the Test of Understanding (TOU), or the parent/guardian must pass the TOU.
Who cannot join
- Participants in the EBOVAC-Salone trial who received at least 1 dose of the Ebola vaccine regimen.
- Subjects who have received any candidate or other Ebola vaccine.
- Subjects who have a 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).
- Subjects who have a known history of any thrombotic disorder, thrombocytopaenia, thrombotic thrombocytopaenia syndrome (TTS), or heparin-induced thrombocytopaenia and thrombosis (HITT).
- Subjects with presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38° C 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.
- Subjects with a 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.
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- Women who are known to be pregnant or planning to become pregnant while enrolled in the study.
- Subjects who have received a blood transfusion or other blood products within 8 weeks prior to vaccination day.
- Subjects who have been vaccinated with live-attenuated vaccines within 30 days before the study vaccination, or with an inactivated vaccine within 15 days before the study vaccination.
- Subjects 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.
- Subjects with 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: A Phase 2, Open-label, Study to Evaluate the Safety and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV, MVA-BN-Filo in Adults and Children Originally Enrolled in the Control Arm of the EBOVAC-Salone Study
This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study
Read the detailed description
This study is being conducted to assess the safety and immunogenicity of the Ad26.ZEBOV (Dose 1), MVA-BN-Filo (Dose 2) vaccine regimen, administered with a 56-day interval between the two doses, in adults and children previously enrolled in the control arm of the VAC52150EBL3001 (EBOVAC-Salone) study.
The heterologous, 2-dose Ebola vaccine regimen is comprised of the following 2 Ebola vaccines:
- Ad26.ZEBOV - an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant
- MVA-BN-Filo - a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus
STUDY OBJECTIVES AND HYPOTHESIS
Primary Objectives:
- To assess the safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen administered intramuscularly with a 56-day interval between the two doses.
- To quantify and characterise cellular immune responses to EBOV-GP induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen as measured by cell mediated immunity assays at 56 days post Dose 1 and 21 days post Dose 2.
Secondary Objective:
- To evaluate humoral immune responses against EBOV GP induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen as measured by enzyme-linked immunosorbent assay (ELISA) at 56 days post Dose 1 and 21 days post Dose 2.
Exploratory Objectives:
- To characterise binding antibodies induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen using LUMINEX technology.
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 STUDY DESIGN This is a Phase 2, open-label study to evaluate the safety and immunogenicity of Ad26.ZEBOV (first vaccination) at a dose of 5x10^10 viral particles (vp) followed by MVA-BN-Filo (second vaccination) at a dose of 1x10^8 infectious units (Inf U) administered 56 days later in healthy adults and children.
Only subjects from the feeder study, VAC52150EBL3001 (EBOVAC-Salone), who were enrolled in the control arm (did not received the Ebola vaccine regimen) are eligible for enrollment in this study.
Potential participants or parents/guardians of potential participants will be asked to consent for their participation or their children's participation in the study. Children aged 7 years and older at the time of enrollment in this study will be asked to give positive assent for their participation. Participants will be followed up for 28 days following Dose 2 vaccination. The study will be conducted in Kambia, Sierra Leone.
Study population: subjects must be healthy adults and children (based on physical examination, medical history, and clinical judgment) who were in the control arm in the VAC52150EBL3001 (also known as EBOVAC-Salone) vaccine trial.
Dosage and administration: subjects will receive the following study vaccines as a 0.5 millilitres (mL) intramuscular (IM) injection into the deltoid:
- Ad26.ZEBOV at a dose of 5x1010 vp on Day 1
- MVA-BN-Filo at a dose of 1x108 Inf U on Day 57
Safety evaluations: for children ages 4-11 years, solicited local (at the injection site) and systemic adverse events will be assessed using a symptom diary for a period of seven days following each vaccination. For all participants, serious adverse events will be reported from Dose 1 vaccination until their last study visit.
Immunogenicity evaluations: blood will be drawn for assessments of humoral and cellular immune responses at the Day 1, Day 57, and Day 78 visits. Blood samples for cellular immune responses will only be collected in a subset of participants; 30 participants aged 4-11 years, 30 participants aged12-17 years, and 30 participants aged 18 years and older.
STATISTICAL METHODS The primary analysis will be conducted when all subjects have completed the 28 days post-Dose 2 visit or discontinued earlier. This analysis will include all available data up to this point.
Sample size determination: up to 245 adults and children will be invited to enroll into this trial and included in safety and humoral immunogenicity evaluations. This number is based on the potentially available participants in EBOVAC-Salone who were enrolled into the control groups.
A randomly selected subset of 90 participants (including 30 aged 4-11 years, 30 aged 12-17 years and 30 aged 18 years and older) will be included in the cellular immunogenicity subset. Inclusion of 90 participants will enable estimation of the proportion of participants with detectable post-vaccination EBOV-specific T cell subsets of interest with an acceptable level of precision.
Safety analysis: no formal statistical testing of safety data is planned. Safety data will be analysed descriptively by age the participant is when s/he received Dose 1 of the Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo), based on the age groups: 4-11 years, 12-17 years, 18 years and older.
Immunogenicity analyses:
The investigators will calculate the proportion of participants with detectable EBOV-specific T cell subsets of interest at baseline, 56 days post dose 1 and at 21 days post dose 2 with exact binomial 95% confidence intervals (CIs).
A similar approach will be taken in analyses of antibody responses (using both ELISA and LUMINEX). The proportion of participants with an EBOV-specific antibody response will be calculated with 95% CIs at baseline and follow up visits, and the magnitude of the observed antibody responses will be described at each visit using measures of central tendency and spread.
Immunogenicity analyses will be performed first among all participants with contributing data (up to n=245 for humoral responses; n=90 for cellular responses), and second stratified by age group.
- Conditions
- Virus Diseases, Hemorrhagic Fever, Ebola, Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Filoviridae Infections
- Being tested
- Ad26.ZEBOV, MVA-BN-Filo
- Keywords
- Ad26.ZEBOV, MVA-BN-Filo, vaccination, children, adults
- Medical subject headings
- Virus Diseases, Hemorrhagic Fever, Ebola, Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Filoviridae Infections, Mononegavirales Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.ZEBOV, MVA-BN-FiloDrug
Also called VAC52150
Ad26.ZEBOV - is an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant
MVA-BN-Filo - is a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | Subjects will receive the following study vaccines as a 0.5 mL IM injection into the deltoid:
* Ad26.ZEBOV at a dose of 5x10^10 vp on Day 1
* MVA-BN-Filo at a dose of 1x10^8 Inf U on Day 57 Receives: Drug: Ad26.ZEBOV, MVA-BN-Filo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited adverse events in children aged 4-11 years.
Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically
Measured: From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination
Incidence of solicited adverse events in children aged 4-11 years.
Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically
Measured: From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination
Incidence of unsolicited serious adverse events
Number and percentage of participants with any untoward medical event
Measured: From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days)
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Measured: At Day 1 (Dose 1 vaccination)
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Measured: At Day 57 (56 days post-Dose 1 vaccination)
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Measured: At Day 78 (21 days post-Dose 2 vaccination)
Secondary outcomes (1)
Vaccine induced humoral immune responses to EBOV GP
EBOV GP antibody concentration measured by ELISA
Measured: At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start19 Sep 2022
- Primary completion2 Mar 2023
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virus DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 133 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.
- Responsible party
- Sponsor
- Investigators
- Deborah Watson-Jones, PhD, Study chair, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284097
- Sponsor's protocol ID
- VAC52150EBL2012
- Status last verified
- May 2025
- First submitted
- 23 Feb 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical trials results will be published in an open access, peer-reviewed journal, which will include, as feasible, the study protocol. A summary of the study results will be included within the trial resignation record in PACTR and ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Study to Evaluate the Safety and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV, MVA-BN-Filo in Adults and Children Originally Enrolled in the Control Arm of the EBOVAC-Salone Study
- ClinicalTrials.gov ID
- NCT05284097
- Acronym / sponsor ID
- VAC52150EBL2012
- Conditions
- Virus Diseases, Hemorrhagic Fever, Ebola, Infections, Hemorrhagic Fevers, Viral, RNA Virus Infections, Filoviridae Infections
- Keywords
- Ad26.ZEBOV, MVA-BN-Filo, vaccination, children, adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Sierra Leone, Janssen Vaccines & Prevention B.V.
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 17 Mar 2022 (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.
This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study
Detailed description
This study is being conducted to assess the safety and immunogenicity of the Ad26.ZEBOV (Dose 1), MVA-BN-Filo (Dose 2) vaccine regimen, administered with a 56-day interval between the two doses, in adults and children previously enrolled in the control arm of the VAC52150EBL3001 (EBOVAC-Salone) study.
The heterologous, 2-dose Ebola vaccine regimen is comprised of the following 2 Ebola vaccines:
- Ad26.ZEBOV - an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant
- MVA-BN-Filo - a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus
STUDY OBJECTIVES AND HYPOTHESIS
Primary Objectives:
- To assess the safety of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen administered intramuscularly with a 56-day interval between the two doses.
- To quantify and characterise cellular immune responses to EBOV-GP induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen as measured by cell mediated immunity assays at 56 days post Dose 1 and 21 days post Dose 2.
Secondary Objective:
- To evaluate humoral immune responses against EBOV GP induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen as measured by enzyme-linked immunosorbent assay (ELISA) at 56 days post Dose 1 and 21 days post Dose 2.
Exploratory Objectives:
- To characterise binding antibodies induced by the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen using LUMINEX technology.
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 STUDY DESIGN This is a Phase 2, open-label study to evaluate the safety and immunogenicity of Ad26.ZEBOV (first vaccination) at a dose of 5x10^10 viral particles (vp) followed by MVA-BN-Filo (second vaccination) at a dose of 1x10^8 infectious units (Inf U) administered 56 days later in healthy adults and children.
Only subjects from the feeder study, VAC52150EBL3001 (EBOVAC-Salone), who were enrolled in the control arm (did not received the Ebola vaccine regimen) are eligible for enrollment in this study.
Potential participants or parents/guardians of potential participants will be asked to consent for their participation or their children's participation in the study. Children aged 7 years and older at the time of enrollment in this study will be asked to give positive assent for their participation. Participants will be followed up for 28 days following Dose 2 vaccination. The study will be conducted in Kambia, Sierra Leone.
Study population: subjects must be healthy adults and children (based on physical examination, medical history, and clinical judgment) who were in the control arm in the VAC52150EBL3001 (also known as EBOVAC-Salone) vaccine trial.
Dosage and administration: subjects will receive the following study vaccines as a 0.5 millilitres (mL) intramuscular (IM) injection into the deltoid:
- Ad26.ZEBOV at a dose of 5x1010 vp on Day 1
- MVA-BN-Filo at a dose of 1x108 Inf U on Day 57
Safety evaluations: for children ages 4-11 years, solicited local (at the injection site) and systemic adverse events will be assessed using a symptom diary for a period of seven days following each vaccination. For all participants, serious adverse events will be reported from Dose 1 vaccination until their last study visit.
Immunogenicity evaluations: blood will be drawn for assessments of humoral and cellular immune responses at the Day 1, Day 57, and Day 78 visits. Blood samples for cellular immune responses will only be collected in a subset of participants; 30 participants aged 4-11 years, 30 participants aged12-17 years, and 30 participants aged 18 years and older.
STATISTICAL METHODS The primary analysis will be conducted when all subjects have completed the 28 days post-Dose 2 visit or discontinued earlier. This analysis will include all available data up to this point.
Sample size determination: up to 245 adults and children will be invited to enroll into this trial and included in safety and humoral immunogenicity evaluations. This number is based on the potentially available participants in EBOVAC-Salone who were enrolled into the control groups.
A randomly selected subset of 90 participants (including 30 aged 4-11 years, 30 aged 12-17 years and 30 aged 18 years and older) will be included in the cellular immunogenicity subset. Inclusion of 90 participants will enable estimation of the proportion of participants with detectable post-vaccination EBOV-specific T cell subsets of interest with an acceptable level of precision.
Safety analysis: no formal statistical testing of safety data is planned. Safety data will be analysed descriptively by age the participant is when s/he received Dose 1 of the Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo), based on the age groups: 4-11 years, 12-17 years, 18 years and older.
Immunogenicity analyses:
The investigators will calculate the proportion of participants with detectable EBOV-specific T cell subsets of interest at baseline, 56 days post dose 1 and at 21 days post dose 2 with exact binomial 95% confidence intervals (CIs).
A similar approach will be taken in analyses of antibody responses (using both ELISA and LUMINEX). The proportion of participants with an EBOV-specific antibody response will be calculated with 95% CIs at baseline and follow up visits, and the magnitude of the observed antibody responses will be described at each visit using measures of central tendency and spread.
Immunogenicity analyses will be performed first among all participants with contributing data (up to n=245 for humoral responses; n=90 for cellular responses), and second stratified by age group.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Drug: Ad26.ZEBOV, MVA-BN-FiloSubjects will receive the following study vaccines as a 0.5 mL IM injection into the deltoid: * Ad26.ZEBOV at a dose of 5x10^10 vp on Day 1 * MVA-BN-Filo at a dose of 1x10^8 Inf U on Day 57 |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Must have been enrolled in the control arm and received at least the first vaccination (Dose 1) in EBOVAC-Salone.
- Must consent to participate, or their parent/guardian must consent for their child to participate, in the VAC52150EBL2012 study.Children aged 7 years and older will be asked to give positive assent for their participation in the study.
- Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol, or the parent/guardian must be willing/able to ensure that their child adheres to the prohibitions and restrictions specified in the protocol
- 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.
- Female subjects of childbearing potential, who have started their menstrual periods and/or are ≥12 years of age at the time of screening must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before vaccination until the end of the study, with a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test at screening and immediately prior to the vaccination, which shall occur no earlier than 14 days after the screening visit.
Key exclusion criteria (11 listed)
- Participants in the EBOVAC-Salone trial who received at least 1 dose of the Ebola vaccine regimen.
- Subjects who have received any candidate or other Ebola vaccine.
- Subjects who have a 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).
- Subjects who have a known history of any thrombotic disorder, thrombocytopaenia, thrombotic thrombocytopaenia syndrome (TTS), or heparin-induced thrombocytopaenia and thrombosis (HITT).
- Subjects with presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38° C 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.
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, MVA-BN-FiloAlso: VAC52150Ad26.ZEBOV - is an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant MVA-BN-Filo - is a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus | Drug | Study Intervention |
Primary outcome
Incidence of solicited adverse events in children aged 4-11 years.
Time frame: From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination
Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically
Incidence of solicited adverse events in children aged 4-11 years.
Time frame: From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination
Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically
Incidence of unsolicited serious adverse events
Time frame: From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days)
Number and percentage of participants with any untoward medical event
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Time frame: At Day 1 (Dose 1 vaccination)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Time frame: At Day 57 (56 days post-Dose 1 vaccination)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Time frame: At Day 78 (21 days post-Dose 2 vaccination)
Proportion of participants with detectable EBOV-specific T cell subsets of interest
1 secondary outcome
Vaccine induced humoral immune responses to EBOV GP
Time frame: At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 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 11 May 2025.
- Individual participant dataSharing planned: Yes. The clinical trials results will be published in an open access, peer-reviewed journal, which will include, as feasible, the study protocol. A summary of the study results will be included within the trial resignation record in PACTR and ClinicalTrials.gov
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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 study chair
London School of Hygiene and Tropical Medicine
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, MVA-BN-Filo in people with Virus Diseases and Hemorrhagic Fever, Ebola, 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 8 inclusion and 11 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 11 May 2025. 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?
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?
Incidence of solicited adverse events in children aged 4-11 years. (time frame: From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2025.