Middle East Respiratory Syndrome Coronavirus Clinical Trial
Official title:
A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults
Background:
Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal
respiratory virus. People often get MERS through close contact with an infected person.
Scientists are worried that MERS may spread and cause more infections. There are no vaccines
or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able
to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of
antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid
part of cow blood.
Objective:
To evaluate the safety and tolerability of SAB-301 in healthy adults.
Eligibility:
Healthy people ages 18 60 who:
Do not have chronic medical problems
Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal
allergy meds and oral contraception)
Do not have allergies to beef products
Agree to use two forms of contraception while on study (both men and women)
Design:
Participants will be screened with:
Medical history
Physical examination
Blood and urine tests
Participants will have a return visit.
They will have a physical exam and blood tests.
They will be randomly assigned to receive either SAB-301 or a placebo which is given by
infusion
through an arm vein over 1 3 hours.
They will be monitored at the clinic for 6 hours after the infusion. They will have
additional blood draws.
Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each
visit they will be evaluated and have blood and urine tests.
The administration of convalescent plasma or hyperimmune immunoglobulin is often used for
treatment of emerging infectious diseases. However, production of large quantities of
anti-pathogen human plasma and/or immunoglobulin with high affinity and avidity antibodies
currently requires donations by convalescent humans, a process that can limit availability
for a number of reasons. One novel alternative source is transchromosomic (Tc) cattle that
produce fully human polyclonal IgG (hIgG) de novo and mount a robust antibody immune response
after vaccination.
This study will evaluate the safety, tolerability, and immunogenicity of SAB-301, a fully
human polyclonal anti-MERS IgG collected from transchromosomic cattle. Beginning with a low
single-dose, subjects are randomized to receive either SAB-301 or a normal saline control,
and evaluated on Study Days 1, 3, 7, 21, 42, and 90. The safety and tolerability is evaluated
using symptoms, clinical laboratory tests, pharmacokinetics, and immunogenicity assays.
Utilizing a series of stopping rules and a medical monitor, the dose will be escalated as
safety and tolerability are established.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04170829 -
A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
|
Phase 1 |