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
Condition: Healthy Adult Immune Responses to Vaccine
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

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) 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 18-66

      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 to have extra clinic visits and laboratory tests if they have
           health changes that need to be checked.
    

Detailed description: 
      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.
    

Intervention name(s): VRC-EBOMVA079-00-VP (MVA-EbolaZ); VRC-EBOADC069-00-VP (cAd3-EBO)
Intervention type(s): Biological; Biological
Intervention description(s): Ebola Modified Vaccinia Virus Ankara Vaccine; Ebola Chimpanzee Adenovirus Vector Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunity; Ebola Virus; Ebola Hemorrhagic Fever; Healthy; Filovirus