NCT02408913

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

Completed Phase 1 Last updated 11 April 2019

What this trial tests

Phase 1 trial testing VRC-EBOMVA079-00-VP (MVA-EbolaZ) in Healthy Adult Immune Responses to Vaccine in 140 participants. Completed in 6 April 2017.

Timeline

26 March 2015

Primary endpoint
6 April 2017

6 April 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	140
Start date	26 March 2015
Primary completion	6 April 2017
Estimated completion	6 April 2017
Sites	3 locations across United States

Drugs / interventions tested

• VRC-EBOMVA079-00-VP (MVA-EbolaZ) — full drug profile →
• VRC-EBOADC069-00-VP (cAd3-EBO) — full drug profile →

Conditions studied

• Healthy Adult Immune Responses to Vaccine — all drugs for Healthy Adult Immune Responses to Vaccine →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 66, any sex, with Healthy Adult Immune Responses to Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Functional interrogation and mining of natively paired human V_H:V_L antibody repertoires.
   Wang B, DeKosky BJ, Timm MR, Lee J, et al · · 2018 · cited 115× · PMID 29309060 · DOI 10.1038/nbt.4052
2. Development of novel vaccine vectors: Chimpanzee adenoviral vectors.
   Guo J, Mondal M, Zhou D. · · 2018 · cited 53× · PMID 29300685 · DOI 10.1080/21645515.2017.1419108
3. Ebola: Lessons on Vaccine Development.
   Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
4. Ebola vaccines in clinical trial: The promising candidates.
   Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
5. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
   Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
6. Ebola Virus Infection: Overview and Update on Prevention and Treatment.
   Martínez MJ, Salim AM, Hurtado JC, Kilgore PE. · · 2015 · cited 23× · PMID 26363787 · DOI 10.1007/s40121-015-0079-5
7. Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial.
   Mwesigwa B, Houser KV, Hofstetter AR, Ortega-Villa AM, et al · · 2023 · cited 19× · PMID 37544326 · DOI 10.1016/s1473-3099(23)00344-4
8. Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials.
   Happe M, Hofstetter AR, Wang J, Yamshchikov GV, et al · · 2024 · cited 11× · PMID 38553525 · DOI 10.1038/s41541-024-00833-z