Clinical Trial: VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boos

Brief Summary:

Background:

- Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP ( MVA-EbolaZ g) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola.

Objectives:

- To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines.

Eligibility:

- Healthy adults ages 18-50.

Design:

• Participants will get one or two study vaccine injections depending on the study group they are assigned to. Each injection will repeat the same schedule:
• A needle and syringe will inject the vaccine into an upper arm muscle.
• 1-2 days later, participants must call the clinic to report how they feel.
• For 7 days they will check their temperature with a thermometer given to them. They will look at the injection site, and measure any redness or swelling with a ruler. They will write down any symptoms they have.
• In the first 2 months, participants will have at least 6 clinic visits and 1 phone contact. At each visit, participants will be checked for health changes or problems. They will tell how they feel and if they have taken any medications. Blood and urine samples may be collected.
• Participants might need
  

  Detailed Summary: This Phase 1/1b study will examine dose, safety, tolerability and immunogenicity of an investigational MVA-vectored Ebola vaccine in healthy adults. The vaccine encodes wild type (WT) glycoprotein (GP) from Zaire strain of Ebola and will be administered intramuscularly (IM) with needle and syringe. The safety and tolerability of the MVA-EbolaZ will be evaluated at escalating doses of 1x10(7) and 1x10(8) plaque forming units (PFU). Part 1 includes enrollment of vaccine-naive subjects to conduct a dose escalation of the MVA-EbolaZ vaccine and to evaluate the vaccine as a boost for the cAd3-EBO vaccine. In Part 2 of the study, up to 140 subjects who received the cAd3-EBO or cAd3-EBOZ vaccine in VRC 207 study will be boosted with MVA-EbolaZ. The hypotheses are that the study vaccines will be safe and elicit immune responses to Ebola GP, and that the prime-boost regimens will be safe and result in a more polyfunctional response to Ebola GP that is of greater magnitude and duration than response to either of the vaccines alone.
  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
  

  Current Primary Outcome:

  • Local and systemic reactogenicity signs and symptoms. [ Time Frame: Daily for 7 days following the vaccination ]
  • Occurrence of adverse events of all severities. [ Time Frame: Through 4 weeks after each injection ]
  • Occurrence of serious adverse events and new chronic medical conditions. [ Time Frame: Through 48 weeks after last injection ]
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Antibody responses as measured by ELISA and neutralization assays. [ Time Frame: 4 weeks after vaccination. ]
  • T cell responses as measured by intracellular cytokine staining (ICS)assay. [ Time Frame: 4 weeks after vaccination. ]
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: April 3, 2015
  Date Started: March 26, 2015
  Date Completion:
  Last Updated: May 12, 2017
  Last Verified: April 6, 2017