A Phase 2 interventional study of Ad26.ZEBOV, MVA-BN-Filo in Virus Diseases, Hemorrhagic Fever, Ebola and Infections, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Sierra Leone. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 2, Interventional, and Prevention
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
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:
STUDY OBJECTIVES AND HYPOTHESIS
Primary Objectives:
Secondary Objective:
Exploratory Objectives:
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:
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.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 133 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Compared within Hemorrhagic Fever, Ebola, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Virus Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Ad26.ZEBOV, MVA-BN-Filo
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
Also known as: VAC52150
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Day 78 (21 days post-Dose 2 vaccination)
Vaccine induced humoral immune responses to EBOV GP
EBOV GP antibody concentration measured by ELISA
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)
Vaccine induced humoral immune response to EBOV GP
EBOV GP antibody concentration measured by LUMINEX assay
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)
Plan to share: 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
Supporting information: Study protocol
Time frame: within 12 months of the study completion date
Access criteria: open
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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