Prevention of Zika Infection Clinical Trial
Official title:
VRC 319: A Phase I/Ib, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of A Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults
Background:
The Zika virus is passed to humans by infected mosquitos. It usually causes fever, rash,
joint pain, and red eyes. Recently, some cases of microcephaly (abnormally small head) were
reported in babies born to mothers infected with the Zika virus. Rare cases of a severe nerve
weakness called Guillain-Barr(SqrRoot)(Copyright) syndrome were reported in some people with
Zika virus infection. There is currently no cure for or vaccine against the infection.
VRC-ZKADNA085-00-VP is a new vaccine that instructs the body to make a small amount of Zika
virus protein. The body may use this to build an immune response.
Objective:
To see if VRC-ZKADNA085-00-VP is safe and causes any side effects.
Eligibility:
Healthy people ages 18 35
Design:
Participants will be screened through a separate protocol with:
- Medical history
- Physical exam
- Lab and urine tests
Participants will be randomly assigned to 1 of 4 study groups. They will have about 18 clinic
visits over 2 years. Most will occur in the first year, with long-term follow-up visits at
months 18 and 24. Visits include a physical exam and blood and urine tests.
Participants will have vaccine injections. A high-pressure device pushes the vaccine through
the skin and into the muscle of the upper arm. They will have 2-3 injections depending on
their group.
Vaccine visits last 4-6 hours. Others last 1-2 hours.
Participants will keep a diary for 7 days after each injection. They will record their
temperature and measure any skin changes at the injection site each day.
Participants might have extra visits and blood tests if they have health changes.
Study Design:
This is a Phase I/Ib, randomized, multicenter clinical study to evaluate the safety,
tolerability, and immunogenicity of four vaccination regimens against Zika virus (ZIKV)
disease. Vaccination regimens with the VRC-ZKADNA085-00-VP (ZIKV DNA) vaccine administered on
Day 0 and Week 8 (Group 1); on Day 0 and Week 12 (Group 2); on Day 0, Weeks 4 and 8 (Group
3); and on Day 0, Weeks 4 and 20 (Group 4) will be tested. The primary hypothesis is that the
ZIKV DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is
that all vaccine regimens will elicit a ZIKV-specific immune response. The primary objectives
are to evaluate the safety and tolerability of the investigational vaccine regimens in
healthy adults. Secondary objectives are related to the immunogenicity of the vaccination
regimens.
Product Description:
The investigational VRC-ZKADNA085-00-VP vaccine was developed by the Vaccine Research Center
(VRC), NIAID, and is composed of a single closed-circular DNA plasmid that encodes the wild
type precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of
ZIKV. Vaccine is supplied in single dose vials at a concentration of 4 mg/mL. ZIKV DNA
vaccine dose will be 4 mg administered as an intramuscular (IM) injection in the deltoid
muscle.
Subjects:
Healthy adults 18 to 35 years of age.
Study Plan:
Subjects will be enrolled at up to 3 study sites, randomized equally into the 4 study groups,
and will receive 2-3 vaccinations. The protocol requires up to 18 scheduled clinic visits and
a telephone follow-up contact after each study injection. Solicited reactogenicity will be
evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical
observation and monitoring of hematological and chemical parameters at clinical visits
through the 44 weeks on the study.
-VRC 319 Study Schema
- Group:1; Subjects*: 20; Day 0; Week 8;
- Group:2; Subjects*: 20; Day 0; Week 12;
- Group:3; Subjects*: 20; Day 0; Week 4; Week 8;
- Group:4; Subjects*: 20; Day 0; Week 4; Week 20;
- TOTAL; Subjects*: 80
- Up to 120 total enrollments are permitted if additional subjects are needed for
assessment of safety and immune responses.
Study Duration:
Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks
following the first vaccine administration and for durability of immune responses at two
additional long term follow-up visits at 18 and 24 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02996461 -
VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, inHealthy Adults
|
Phase 1 |