Vaccine Info

mAb114 Ebola Therapeutic Vaccine

Description  

mAb114 is a human IgG1 MAb targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP). 

mAb114 is a single monoclonal antibody which binds to the core receptor binding domain of the Zaire ebolavirus surface protein, preventing the virus from infecting human cells.

Indication

mAb114 is indicated to protect from the Ebola virus

Dosage

mAb114 is administered by IV infusion at dosages of 5, 25 and 50 mg/kg in the clinical trial

Updates

September 6, 2019: Ridgeback Biotherapeutics LP announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation. 

August 13, 2019: The first-ever multi-drug randomized control trial aimed at evaluating the safety and efficacy of Ebola Zaire therapeutic medications reported 2 experimental products will continue to be studied. 

The Pamoja Tulinde Maisha study’s investigational agents were ZMapp, remdesivir, mAb114, and REGN-EB3.

An independent Data and Safety Monitoring Board (DSMB) reported the results of their review on August 9, 2019, recommending that the current study be stopped.

Additionally, this DSMD said ‘all future study participants should be randomized to receive either the REGN-EB3 or mAb114 medications.’

Clinical Trials

Clinical Trial NCT03719586: Investigational Therapeutics for the Treatment of People With Ebola Virus Disease

  • Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers.
  • Objective: To study the safety and effectiveness of 4 drugs for people with Ebola virus.
  • Eligibility: People of any age with Ebola infection who are in treatment centers
  • Design: Participants will be screened with questions, medical history, and blood tests.
  • Participants will be randomly assigned to get 1 of 3 study drugs:
    • ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.
    • Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.
    • Mab114 by IV for 30-60 minutes. It will be given 1 time.
    • REGN-EB3 by IV for about 2 hours. It will be given 1 time.
  • For at least a week, participants will stay in isolation in a clinic. They will:
    • Get supportive care and be monitored
    • Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.
    • Get their study drug.
    • Be monitored for disease signs and drug side effects. They may get medicines for side effects.
    • Have blood and urine tests.
  • Participants will stay in the clinic until they finish the study drug and are well enough to leave.
  • Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.

Clinical Trial NCT03478891Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults

  • Ebola is a virus that has infected and killed people mostly in West Africa. There is no treatment or prevention for it, but several drugs are being studied. Researchers want to test the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for Ebola treatment in people who are infected in the future. This trial will not expose volunteers to the Ebola virus.
  • Objectives: To see if MAb114 is safe and how a person's body responds to it.
  • Eligibility: Healthy adults ages 18-60 who weigh 220.5 pounds or less
  • Design: Participants will be screened under protocol NIH 11-I-0164 with:
    • Medical history
    • Physical exam
    • Blood or urine tests
  • Participants will have a first 8- to1 0-hour visit. They will get MAb114 by IV infusion. For this, a thin tube will be placed in an arm vein. They may get an IV line in their other arm to collect blood. Blood will be taken many times before and after the infusion. Participants may have a urine test.
  • Participants will get a thermometer to check their temperature for 3 days after they get MAb114. They will record their highest temperature and any symptoms.
  • Participants will have about 14 more study visits over 6 months. At each visit, they will have blood taken and be checked for any health changes. They will talk about how they are feeling and if they have taken any medications.
  • At the end of the 6 months, participants may be invited to take part in another study for follow-up sample collection.
Updated
September 12th, 2019