A Phase 2 interventional study of VSVG-ZEBOV and ChAd3-EBO Z in Ebola Virus, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Liberia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
Background:
Objectives:
Eligibility:
Design:
Ebola virus disease (EVD) in West Africa is spreading rapidly, and there is a critical need for a vaccine to prevent EVD. There are two candidate Ebola virus vaccines, the chimpanzee adenovirus 3 (ChAd3-EBO Z)-based vaccine and the Vesicular Stomatitis virus (VSVdeltaG-ZEBOV)-based vaccine. This study will evaluate both of these vaccines in a randomized, double-blind, controlled, 3-arm study in Liberia. Each vaccine will be compared against the same active control. Because there are limited data on the safety of these vaccines, the initial phase (phase 2) of the study will include the collection of more detailed data on safety and will define the immune response elicited by each vaccine in the first 600 volunteers. With the decline in new cases of Ebola virus infection the phase 3 component was no longer deemed to be feasible and, following safety, ethical and FDA approve/concurrence, the study was amended to a more robust, 1,500 person phase 2 design.
With the amendment to only a phasae 3 study the endpoint reverted to the phase 2 endpoint of safety and immunogenicity.
Participants aged 18 year and older will be enrolled at health clinics in Monrovia, Liberia over 4 months. A single dose of the assigned agent will be administered. Participants in phase 2 will undergo blood draw and assessment of adverse events (AEs) and signs and symptoms of Ebola infection at 1 week and 1 month after vaccination, and monthly assessment of AEs and signs and symptoms of Ebola thereafter. Participants in phase 3 will undergo monthly assessment of AEs and signs and symptoms of Ebola infection after vaccination. All participants will be followed for 8 to 12 months.
This clinical trial to evaluate vaccine efficacy will provide an accurate assessment of the benefits and risks associated with each candidate vaccine and inform policy on wider scale vaccination in other countries.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
The inclusion criteria for the study are broad reflecting the target population that would eventually receive an efficacious vaccine.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
ChAd3-EBO Z
Biological: ChAd3-EBO Z
VSVG-ZEBOV
Biological: VSVG-ZEBOV
Placebo (Saline)
Biological: Placebo
The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
Serious Adverse Events.
Number of Participants Experiencing Serious Adverse Events in First 30 Days
Time frame: One month
Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.
Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry
Time frame: One month
| Milestone | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) |
|---|---|---|---|
| Started | 500 | 500 | 500 |
| Completed | 492 | 491 | 494 |
| Not completed | 8 | 9 | 6 |
Number of Participants Experiencing Serious Adverse Events in First 30 Days
| Participants | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) |
|---|---|---|---|
| Serious Adverse Events. | 6 | 6 | 8 |
Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry
| EU/mL | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) |
|---|---|---|---|
| Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. | 621 (565 to 682) | 1000 (910 to 1099) | 75 (69 to 80) |
Collected over First 30 days after vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ChAd3-EBO Z | 0/500 (0%) | 6/500 (1.2%) | 0/500 (0%) |
| VSVG-ZEBOV | 0/500 (0%) | 6/500 (1.2%) | 0/500 (0%) |
| Placebo (Saline) | 1/500 (0.2%) | 8/500 (1.6%) | 0/500 (0%) |
| Event | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) |
|---|---|---|---|
| MalariaInfections and infestations | 2/500 | 6/500 | 6/500 |
| AnaemiaBlood and lymphatic system disorders | 1/500 | 0/500 | 0/500 |
| DiarrhoeaGastrointestinal disorders | 1/500 | 0/500 | 0/500 |
| Typhoid feverInfections and infestations | 1/500 | 0/500 | 0/500 |
| Vaginal haemorrhageReproductive system and breast disorders | 0/500 | 0/500 | 1/500 |
| Chest injuryInjury, poisoning and procedural complications | 1/500 | 0/500 | 0/500 |
| Pheumocystis jirovecii pheumoniaInfections and infestations | 0/500 | 0/500 | 1/500 |
| Age, Continuous(years) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Median | 30 (25 to 38) | 29 (24 to 36) | 30 (24 to 39) | 30 (24 to 38) |
| Sex: Female, Male(Participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Female | 185 | 187 | 177 | 549 |
| Male | 315 | 313 | 323 | 951 |
| Region of Enrollment(participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Liberia | 500 | 500 | 500 | 1500 |
| Contact past month with someone who had Ebola(Participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Count of participants | 1 | 5 | 5 | 11 |
| Work involves contact with persons with Ebola(Participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Count of participants | 22 | 25 | 22 | 69 |
| HIV Positive(Participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Count of participants | 25 | 22 | 31 | 78 |
| Syphilis positive(Participants) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Count of participants | 30 | 22 | 25 | 77 |
| IgG antibody level (EU/mL)(EU/mL) | ChAd3-EBO Z | VSVG-ZEBOV | Placebo (Saline) | Total |
|---|---|---|---|---|
| Median | 75 (44 to 135) | 81 (49 to 141) | 79 (50 to 148) | 78 (47 to 139) |
1 further baseline measures are reported on the registry.
The record gives a start of Jan 2015, a primary completion of Jun 2016 and a completion of Nov 2020. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2017, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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