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Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults

NCT04723602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-03

No results posted yet for this study

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

Conditions

  • Ebola Virus Disease
  • Marburg Virus Disease

Interventions

BIOLOGICAL

cAd3-Marburg

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.

BIOLOGICAL

cAd3-EBO-S

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.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Oklahoma Blood Institute

    collaborator OTHER

  • Albert B. Sabin Vaccine Institute

    lead OTHER

Principal Investigators

  • Roxana Rustomjee, MBChB · The Albert B. Sabin Vaccine Institute

  • Michael Stevenson, MD · Oklahoma Blood Institute

  • David Hoover, MD · ICON plc

  • Tuan Le, MD · Oklahoma Blood Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2021-12-14
Completion
2021-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723602 on ClinicalTrials.gov