CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
cAd3-Marburg +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04723602
NCT04723602Phase 1Completed
CompareCT.gov

Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for the Purposes of Assay Development

Albert B. Sabin Vaccine Institute·interventional·Posted Jan 26, 2021·Updated Aug 3, 2022

In Brief

A Phase 1 clinical trial evaluating cAd3-Marburg and cAd3-EBO-S for Ebola Virus Disease and Marburg Virus Disease. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Primary Objective: • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10\^11 particle units (PU) to healthy adults. Secondary Objectives: * To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg) (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked immunosorbent assay) ELISA * To collect sufficient post-vaccination plasma to support further development of filovirus assays

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEbola Virus Disease, Marburg Virus Disease
CountriesUnited States
CollaboratorsICON plc, Oklahoma Blood Institute

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 26, 2021
Enrollment StartJan 6, 2021
Primary CompletionDec 14, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago

Interventions

cAd3-Marburgbiological

A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10\^11 Particle Units (PU) vaccine.

cAd3-EBO-Sbiological

A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10\^11 Particle Units (PU) vaccine.