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Ad26.ZEBOV 5*10^10 viral particles

Phase 3

Undisclosed | Monoclonal antibody | Other |Johnson & Johnson|Trials Updated: May 25, 2025

Ad26.ZEBOV 5*10^10 viral particles target and mechanism

ModalityMonoclonal antibody

Also known as Ad26.ZEBOV 5*10^10 viral particles (vp)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment525

FDA Designations

No designations recorded

Ad26.ZEBOV 5*10^10 viral particles clinical trials

Ad26.ZEBOV 5*10^10 viral particles · 1 trial · 1 indication

Phase 3 1
NCT02543567A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult ParticipantsHealthy
COMPLETED525 Analytics
PHASE3COMPLETED
A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
At 21 days post boost vaccination

The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody

Secondary Endpoints

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Up to 42 days post boost vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALAd26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57
Group 2EXPERIMENTALAd26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57
Group 3EXPERIMENTALAd26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57
Group 4EXPERIMENTALParticipants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57

Interventions

NameTypeDescription
Ad26.ZEBOV 5*10^10 viral particles (vp)BIOLOGICALAd26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Ad26.ZEBOV 2*10^10 (vp)BIOLOGICALAd26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1
Ad26.ZEBOV 0.8*10^10 (vp)BIOLOGICALAd26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1
MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]BIOLOGICALMVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57
MVA-BN-Filo 5*10^7 Inf. U.BIOLOGICALMVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57
PlaceboBIOLOGICALOne 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion criteria : * Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening * Must be healthy on the basis of clinical laboratory tests performed at Screening * Before randomizat...

Countries:United States
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Frequently asked questions about Ad26.ZEBOV 5*10^10 viral particles

What is Ad26.ZEBOV 5*10^10 viral particles?

Ad26.ZEBOV 5*10^10 viral particles is a vaccine candidate developed by Johnson & Johnson, known by the ticker JNJ. It is an investigational product studied in healthy adult volunteers. The 5*10^10 viral particles figure refers to the dose level of the Ad26.ZEBOV component evaluated in clinical testing.

Who makes Ad26.ZEBOV 5*10^10 viral particles?

Ad26.ZEBOV 5*10^10 viral particles is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical study evaluating this dose level of the vaccine candidate in healthy adult participants.

What phase is Ad26.ZEBOV 5*10^10 viral particles in?

Ad26.ZEBOV 5*10^10 viral particles has been studied in a Phase 3 clinical trial. That trial, NCT02543567, is listed as completed. The candidate is investigational and is not described as approved.

What clinical trials is Ad26.ZEBOV 5*10^10 viral particles in?

Ad26.ZEBOV 5*10^10 viral particles was evaluated in the Phase 3 trial NCT02543567, titled A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants. The trial enrolled 525 participants in the United States, was randomized, double blind, and controlled, and is now completed.

Is Ad26.ZEBOV 5*10^10 viral particles the same as Ad26.ZEBOV 5*10^10 vp?

Yes. Ad26.ZEBOV 5*10^10 viral particles is also written as Ad26.ZEBOV 5*10^10 vp, where vp stands for viral particles. Both forms refer to the same dose level of the Ad26.ZEBOV vaccine candidate developed by Johnson & Johnson.