Hemorrhagic Fever, EbolaPhase 2NCT02564523

Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults

A Phase 2 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Hemorrhagic Fever, Ebola, run by Janssen Vaccines & Prevention B.V. at 7 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata. Read more about this study

Who is it for?: Ages 4 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hemorrhagic Fever, Ebola
What is being tested?: Ad26.ZEBOV and MVA-BN-Filo
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,075 participants
Where: 7 sitesin 4 countries
Study dates: 6 Nov 2015to 12 Feb 2019
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 4 to 70 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Criteria for healthy adults and elderly participants:
Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits
Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
Participant must pass the test of understanding (TOU)
Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants

Show all 11Show fewer

Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of >350 cells/microliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants
Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice
Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive)
Pediatric participants must have received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules

Who cannot join

Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination
For HIV+ adults, no AIDS-defining illnesses

Trial locations and contacts

7 sites in 4 countries.

Country

City, postcode or hospital

7 sites in 4 countries

Burkina Faso2 sites

Study site
BoboDioulasso
Study site
Ouagadougou

Other trials in Burkina Faso

Côte d’Ivoire2 sites

Study site
Abidjan
Study site
Toupah/Ousrou

Other trials in Côte d’Ivoire

Uganda2 sites

Study site
Entebbe
Study site
Kampala

Other trials in Uganda

Kenya1 site

Study site
Nairobi

Other trials in Kenya

About this study

Official title: A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa

Read the detailed description

This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.

Conditions: Hemorrhagic Fever, Ebola
Being tested: Ad26.ZEBOV, MVA-BN-Filo, Placebo
Keywords: Healthy, Vaccine, Ebola viruses, Ebola virus disease (EVD), Filoviruses, Hemorrhagic fever, Monovalent vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector, Safety, Immunogenicity, Inserm, Centre Muraz
Medical subject headings: Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ad26.ZEBOVBiological
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
MVA-BN-FiloBiological
One 0.5 mL IM injection of (1x10*8 infectious units)
PlaceboBiological
One 0.5 mL IM injection of 0.9% saline

Study groups in NCT02564523
Study group	Role	What they receive
Group 1	Experimental	Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo; Biological: Placebo
Group 2	Experimental	Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo; Biological: Placebo
Group 3	Experimental	Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85) Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measured: Up to 28 days post-dose 1 (Day 29)
Number of Participants With Adverse Events (AEs) (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measured: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Adverse Events (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measured: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measured: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
Number of Participants With Adverse Events Post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Measured: Up 28 days post-dose 3 (Day 393)
Number of Participants With Serious Adverse Events
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 3 years and 3 months
Number of Participants With Immediate Reportable Events (IREs)
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Measured: Up to 3 years and 3 months
Number of Participants With Solicited Local Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Measured: 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Local Adverse Events (28-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Measured: Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Measured: Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Local Adverse Events (84-day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Measured: Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Local Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Measured: Up 7 days post-dose 3 (Day 372)
Number of Participants With Solicited Systemic Adverse Events (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Measured: Up to 7 days post-dose 1 (Day 8)
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Measured: Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Measured: Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Measured: Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
Number of Participants With Solicited Systemic Adverse Events (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Measured: Up to 7 days post-dose 3 (Day 372)

Secondary outcomes (2)

Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay
GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL).
Measured: 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Number of Participants With Serious Adverse Events Post-dose 3
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up 28 days post-dose 3 (Day 393)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201512 Feb 2019

First posted30 Sep 2015 (estimated)
Study start6 Nov 2015
Primary completion12 Feb 2019
Study completion12 Feb 2019

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 (3)Papers the sponsor has linked to this study.
Other trials for Hemorrhagic Fever, EbolaStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,075 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02564523
Sponsor's protocol ID: CR107249
Other IDs: VAC52150EBL2002, 2019-000690-22, 2019
Status last verified: Feb 2022
First submitted: 29 Sep 2015
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: No

Publications

Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
PubMed 38603720
Anywaine Z, Barry H, Anzala O, Mutua G, Sirima SB, Eholie S, Kibuuka H, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa SC, Cohen KW, Shukarev G, Katwere M, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Thiebaut R, Douoguih M; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial. PLoS Med. 2022 Jan 11;19(1):e1003865. doi: 10.1371/journal.pmed.1003865. eCollection 2022 Jan.
PubMed 35015777
Barry H, Mutua G, Kibuuka H, Anywaine Z, Sirima SB, Meda N, Anzala O, Eholie S, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa S, Cohen KW, Shukarev G, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Douoguih M, Thiebaut R; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomised, placebo-controlled Phase II clinical trial in Africa. PLoS Med. 2021 Oct 29;18(10):e1003813. doi: 10.1371/journal.pmed.1003813. eCollection 2021 Oct.
PubMed 34714820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
ClinicalTrials.gov ID: NCT02564523
Acronym / sponsor ID: CR107249
Conditions: Hemorrhagic Fever, Ebola
Keywords: Healthy, Vaccine, Ebola viruses, Ebola virus disease (EVD), Filoviruses, Hemorrhagic fever, Monovalent vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,075 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Collaborators: EBOVAC2 Consortium, Institut National de la Santé Et de la Recherche Médicale, France, Centre Muraz
Study start: 6 Nov 2015 (actual)
Primary completion: 12 Feb 2019 (actual)
Study completion: 12 Feb 2019 (actual)
First posted: 30 Sep 2015 (estimated)
Results: Posted 7 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-Filo, Biological: PlaceboParticipants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Group 2	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-Filo, Biological: PlaceboParticipants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
Group 3	Experimental	Biological: Ad26.ZEBOV, Biological: MVA-BN-Filo, Biological: PlaceboParticipants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85)

Who may qualify

Ages: 4 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits
Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
Participant must pass the test of understanding (TOU)
Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants

Key exclusion criteria (6 listed)

Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination

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.ZEBOVOne 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)	Biological	Group 1, Group 2, Group 3
MVA-BN-FiloOne 0.5 mL IM injection of (1x10*8 infectious units)	Biological	Group 1, Group 2, Group 3
PlaceboOne 0.5 mL IM injection of 0.9% saline	Biological	Group 1, Group 2, Group 3

Primary outcome

Number of Participants With Adverse Events (Day 29)
Time frame: Up to 28 days post-dose 1 (Day 29)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Number of Participants With Adverse Events (AEs) (28-Day Interval)
Time frame: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Number of Participants With Adverse Events (56-day Interval)
Time frame: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Number of Participants With Adverse Events (84-day Interval)
Time frame: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Number of Participants With Adverse Events Post-dose 3 (Day 393)
Time frame: Up 28 days post-dose 3 (Day 393)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
Number of Participants With Serious Adverse Events
Time frame: Up to 3 years and 3 months
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Immediate Reportable Events (IREs)
Time frame: Up to 3 years and 3 months
The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.
Number of Participants With Solicited Local Adverse Events (Day 8)
Time frame: 7 days post-dose 1 (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Number of Participants With Solicited Local Adverse Events (28-day Interval)
Time frame: Up to 7 days post-dose 2 (Day 36 for Cohort 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)
Time frame: Up to 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Number of Participants With Solicited Local Adverse Events (84-day Interval)
Time frame: Up to 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Number of Participants With Solicited Local Adverse Events (Day 372)
Time frame: Up 7 days post-dose 3 (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.
Number of Participants With Solicited Systemic Adverse Events (Day 8)
Time frame: Up to 7 days post-dose 1 (Day 8)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)
Time frame: Up to 7 days post-dose 2 (Day 36 for Cohorts 1, 2a, 2b and 3 [28-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)
Time frame: Up 7 days post-dose 2 (Day 64 for Cohort 1, 2a, 2b and 3 [56-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)
Time frame: Up 7 days post-dose 2 (Day 92 for Cohort 1 [84-Day Interval])
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.
Number of Participants With Solicited Systemic Adverse Events (Day 372)
Time frame: Up to 7 days post-dose 3 (Day 372)
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

2 secondary outcomes

Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay
Time frame: 21-days post-dose 2 (Day 50 for Cohorts 1, 2a, 2b, 3 [28-day interval] , Day 78 for Cohort 1, 2a, 2b, 3 [56-day interval] and Day 106 Cohort 1 [84-day interval]
Number of Participants With Serious Adverse Events Post-dose 3
Time frame: Up 28 days post-dose 3 (Day 393)

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval	225	215
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval	43	40
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval	224	214
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval	44	43
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval	110	106
Cohort 1: Placebo, Placebo, 84-Day Interval	22	22
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	59	56
Cohort 2a: Placebo, Placebo, 28-Day Interval	12	12
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval	59	59
Cohort 2a: Placebo, Placebo, 56-Day Interval	12	12
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	55	52
Cohort 2b: Placebo, Placebo, 28-Day Interval	11	10
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval	55	53
Cohort 2b: Placebo, Placebo, 56-Day Interval	10	10
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	54	54
Cohort 3: Placebo, Placebo, 28-Day Interval	12	12
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval	54	54
Cohort 3: Placebo, Placebo, 56-Day Interval	12	11

Primary outcome: Number of Participants With Adverse Events (Day 29)

Time frame: Up to 28 days post-dose 1 (Day 29). Count of participants. Unit: Participants

Measure	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval n = 225	Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval n = 43	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval n = 224	Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval n = 44	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval n = 110	Cohort 1: Placebo, Placebo, 84-Day Interval n = 22	Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 59	Cohort 2a: Placebo, Placebo, 28-Day Interval n = 12	Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 59	Cohort 2a: Placebo, Placebo, 56-Day Interval n = 12	Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 55	Cohort 2b: Placebo, Placebo, 28-Day Interval n = 11	Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 55	Cohort 2b: Placebo, Placebo, 56-Day Interval n = 10	Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 54	Cohort 3: Placebo, Placebo, 28-Day Interval n = 12	Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 54	Cohort 3: Placebo, Placebo, 56-Day Interval n = 12
Value	96	17	68	17	37	6	25	7	25	3	28	4	31	5	23	4	19	4

Population analysed: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo).

Primary outcome: Number of Participants With Adverse Events (AEs) (28-Day Interval)

Time frame: Up to 28 days post-dose 2 (Day 57 for Cohorts 1, 2a, 2b and 3 [28-Day Interval]). Count of participants. Unit: Participants

Measure	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval n = 219	Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval n = 39	Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 58	Cohort 2a: Placebo, Placebo, 28-Day Interval n = 12	Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 55	Cohort 2b: Placebo, Placebo, 28-Day Interval n = 10	Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval n = 54	Cohort 3: Placebo, Placebo, 28-Day Interval n = 12
Value	74	15	22	4	18	4	20	7

Population analysed: Full analysis set included all participants who were randomized and received at least 1 dose of study vaccine (Ad26.ZEBOV, MVA-BN-Filo or placebo). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Primary outcome: Number of Participants With Adverse Events (56-day Interval)

Time frame: Up 28 days post-dose 2 (Day 85 for Cohorts 1, 2a, 2b and 3 [56-Day Interval]). Count of participants. Unit: Participants

Measure	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval n = 200	Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval n = 39	Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 59	Cohort 2a: Placebo, Placebo, 56-Day Interval n = 12	Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 54	Cohort 2b: Placebo, Placebo, 56-Day Interval n = 10	Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval n = 54	Cohort 3: Placebo, Placebo, 56-Day Interval n = 11
Value	58	13	22	4	26	4	22	8

Primary outcome: Number of Participants With Adverse Events (84-day Interval)

Time frame: Up to 28 days post-dose 2 (Day 113 for Cohort 1 [84-Day Interval]). Count of participants. Unit: Participants

Measure	Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval n = 98	Cohort 1: Placebo, Placebo, 84-Day Interval n = 21
Value	34	7

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 years and 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 28-Day Interval	7 of 225 (3.1%)	94 of 225 (41.8%)	0 of 225
Cohort 1: Placebo, Placebo, Placebo, 28-Day Interval	1 of 43 (2.3%)	17 of 43 (39.5%)	0 of 43
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, Ad26.ZEBOV, 56-Day Interval	7 of 224 (3.1%)	80 of 224 (35.7%)	0 of 224
Cohort 1: Placebo, Placebo, Placebo, 56-Day Interval	0 of 44 (0%)	21 of 44 (47.7%)	0 of 44
Cohort 1: Ad26.ZEBOV, MVA-BN-Filo, 84-Day Interval	6 of 110 (5.5%)	43 of 110 (39.1%)	0 of 110
Cohort 1: Placebo, Placebo, 84-Day Interval	0 of 22 (0%)	12 of 22 (54.5%)	0 of 22
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	1 of 59 (1.7%)	24 of 59 (40.7%)	1 of 59
Cohort 2a: Placebo, Placebo, 28-Day Interval	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Cohort 2a: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval	1 of 59 (1.7%)	28 of 59 (47.5%)	0 of 59
Cohort 2a: Placebo, Placebo, 56-Day Interval	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	1 of 55 (1.8%)	29 of 55 (52.7%)	1 of 55
Cohort 2b: Placebo, Placebo, 28-Day Interval	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Cohort 2b: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval	0 of 55 (0%)	33 of 55 (60%)	0 of 55
Cohort 2b: Placebo, Placebo, 56-Day Interval	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 28-Day Interval	1 of 54 (1.9%)	27 of 54 (50%)	0 of 54
Cohort 3: Placebo, Placebo, 28-Day Interval	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Cohort 3: Ad26.ZEBOV, MVA-BN-Filo, 56-Day Interval

Limitations and caveats (from the sponsor): A total of 259 participants in Cohort 1 either did not receive dose 2 (N=52) or received dose 2 outside of their protocol-defined interval (N=207), mainly due to the study pause resulting in a reduced precision for the immunogenicity estimates in the Per Protocol Analysis Set.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38603720Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.
Derived from this study: PubMed 35015777Anywaine Z, Barry H, Anzala O, Mutua G, Sirima SB, Eholie S, Kibuuka H, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa SC, Cohen KW, Shukarev G, Katwere M, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Thiebaut R, Douoguih M; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial. PLoS Med. 2022 Jan 11;19(1):e1003865. doi: 10.1371/journal.pmed.1003865. eCollection 2022 Jan.
Derived from this study: PubMed 34714820Barry H, Mutua G, Kibuuka H, Anywaine Z, Sirima SB, Meda N, Anzala O, Eholie S, Betard C, Richert L, Lacabaratz C, McElrath MJ, De Rosa S, Cohen KW, Shukarev G, Robinson C, Gaddah A, Heerwegh D, Bockstal V, Luhn K, Leyssen M, Douoguih M, Thiebaut R; EBL2002 Study group. Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomised, placebo-controlled Phase II clinical trial in Africa. PLoS Med. 2021 Oct 29;18(10):e1003813. doi: 10.1371/journal.pmed.1003813. eCollection 2021 Oct.

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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.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

7 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Hemorrhagic Fever, Ebola, run by Janssen Vaccines & Prevention B.V. at 7 sites in 4 countries.

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 11 inclusion and 6 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Burkina Faso, Côte d’Ivoire, Uganda, Kenya. 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 7 Mar 2022). 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 Adverse Events (Day 29) (time frame: Up to 28 days post-dose 1 (Day 29)). The study lists 17 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 NCT02564523, which also lists 3 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 7 Mar 2022.