Healthy Adult Immune Responses to Vaccine Clinical Trial
Official title:
VRC 207: A Phase I/1b, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccines, VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ), in Healthy Adults
Background:
- Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a
severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the
largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is
impossible for someone to get an Ebola infection from this vaccine.
Objectives:
- To see if an Ebola vaccine is safe and to study immune responses to it.
Eligibility:
- Healthy adults ages 18-65.
Design:
- Participants will be screened through a separate protocol.
- Participants will receive the vaccine injection by needle and syringe into an upper arm
muscle. - Participants will stay at the clinic for 3 hours after the injection.
- About 2 days later, participants must speak with clinic staff about how they are doing.
- Every day for 7 days after the injection, participants will record their temperature and
symptoms and look at the injection site. They will get a thermometer and a ruler to
measure any redness or swelling. They will report any side effects.
- In the first 2 months in the study, participants will have at least 6 clinic visits and
1 phone call. They will have at least 3 other visits over the next 9 months.
- At each visit, participants will be checked for health changes or problems since their
last visit. They will be asked how they feel and if they have taken any medicine. Blood
will be drawn at most visits. Urine samples may be collected.
Study Design: This is a Phase 1/1b, open-label study to examine safety, tolerability and
immunogenicity of investigational Ebola vaccines in healthy adults. Part 1 is a Phase 1 dose
escalation of the cAd3-EBO vaccine that encodes wild type (WT) glycoproteins (GP) from Zaire
and Sudan strains of Ebolavirus. Part 2 is a Phase 1b further evaluation of the cAd3-EBO
vaccine at the highest dose and evaluation of the Zaire component, which will be provided as
a vaccine designated cAd3-EBOZ. The hypotheses are that the study vaccines, cAd3-EBO and
cAd3-EBOZ, will be safe and will elicit immune responses to Ebola GP. The primary objectives
are to evaluate the safety and tolerability of the study vaccines administered as single
intramuscular (IM) injections at two dose levels. The secondary objectives are related to
evaluation of the immunogenicity.
Product Description: VRC-EBOADC069-00-VP (cAd3-EBO) is composed of two recombinant cAd3
vectors in a 1:1 ratio that express Ebola WT GPs from Zaire and Sudan strains. It is
formulated at 2 times 10(11) PU/mL.
VRC-EBOADC076-00-VP (cAd3-EBOZ) is composed of a cAd3 vector that expresses Ebola WT GP from
the Zaire strain. It is formulated at 1 times 10(11) PU/mL.
VRC-DILADC065-00-VP (diluent) is the formulation buffer used for vaccine production and will
be used when needed to prepare the correct dosage of cAd3-EBO and cAd3-EBOZ.
Subjects: Part 1: Healthy adult volunteers, 18 to 50 years old;
Part 2: Healthy adult volunteers, 18 to 65 years old.
Study Plan: Part 1: 20 subjects will be enrolled, with 10 in each of the two dosage groups
for cAd3-EBO. The dose escalation plan includes daily review of any new safety data by a
study clinician, weekly review of safety data by the protocol team and a staged enrollment
plan with required interim safety reviews before proceeding to the next step. The study plan
includes no more than one enrollment per day for the first 3 vaccinated subjects in each
group. After at least 3 days of follow-up, an interim safety review will occur before
enrollment of additional subjects into the group. When there are at least 2 weeks of
follow-up safety data for the first 3 vaccinated subjects in Group 1, an interim safety
review will occur before proceeding to the next dose level.
Part 2: About 130 subjects will be enrolled as shown in the Schema table.
Group 3 is open only to subjects who received Ebola DNA WT vaccine in protocol VRC 206 to
receive cAd3-EBO as a booster vaccine at the 2 times 10(11) PU dose.
Group 4 is for randomization of subjects to two dosage groups of cAd3-EBOZ.
Group 5 is for further evaluation of the cAd3-EBO vaccine at the 2 times 10(11) PU dose.
Study Duration: Subjects will be evaluated by 9 clinic visits over 48 weeks.
;
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