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Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda

NCT02354404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-12-05

No results posted yet for this study

Summary

Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety, tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2.

Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1 will include at least 60 volunteers who have never received an investigational Ebola vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30 eligible participants who previously participated in the RV247 vaccine clinical trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine.

Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine at the same dose level.

Conditions

  • Hemorrhagic Fever, Ebola

Interventions

BIOLOGICAL

cAd3-EBOZ

cAd3 vaccine vector expressing Ebola glycoprotein from the Zaire strain in single dose vials at 1x10(11) PU/mL.

BIOLOGICAL

cAd3-EBO

1:1 ratio of cAd3 vaccine vectors expressing Ebola glycoprotein from the Zaire and Sudan strains filled into single dose vials at 1x10(11) PU/mL of each \[2x10(11) PU/mL total\].

BIOLOGICAL

MVA-EbolaZ

MVA vaccine vector that expresses Ebola glycoprotein from the Zaire strain in single dose vials at 3.2 x 10(8) PFU/mL

Sponsors & Collaborators

  • US Military HIV Research Program

    collaborator NETWORK

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Merlin Robb, MD · US Military HIV Research Program

  • Julie Ledgerwood, DO · VRC, NIAID, NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-27
Primary Completion
2017-04-19
Completion
2017-04-19

Countries

  • Uganda

Study Locations

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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 NCT02354404 on ClinicalTrials.gov