Tetravalent Chimeric Dengue Vaccine Trial
| Status: | Archived |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | August 2011 |
A Double-Blind Randomized, Placebo-Controlled, Phase I Dose Escalation Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers
The purpose of this study is to test the safety and immune response to a live attenuated
dengue vaccine that could protect people against all 4 types of dengue virus. Live
attenuated means that while this vaccine contains 4 live dengue viruses the viruses have
been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is
spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects
between the ages of 18-45 years old will be enrolled in this research study at Saint Louis
University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4
groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study
procedures include: maintaining a diary to record temperature and side effects, physical
exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples.
Participants will be involved in study related procedures for about 10 months.
The purpose of this study is to evaluate the safety and immunogenicity of a tetravalent
dengue vaccine administered subcutaneously or intradermally. The hypotheses being tested in
this study is whether or not a tetravalent dengue vaccine may be safely administered to
healthy normal individuals by intradermal (ID) or subcutaneous (SC) injection and provide
measurable levels of serum neutralizing antibodies against all four dengue virus serotypes.
The study is also designed to compare safety and immunogenicity between routes of
administration and dose levels. The primary objective of this study is to evaluate the
safety and tolerability of a two-dose regimen tetravalent dengue vaccine administered either
SC or ID to healthy adult volunteers. Two dose levels will be tested in a dose-escalation
format. Safety and tolerability will be measured by conducting post-vaccination safety
assessments including physical examinations, injection site examinations, adverse event
monitoring, hematology, blood chemistry, and urine dipstick. The secondary objective of this
study is to assess the immunogenicity of the vaccine, in terms of neutralizing antibodies,
against all four dengue serotypes when administered at two dose levels by two routes of
administration in healthy adults. Titers of serum neutralizing antibodies will be measured
at pre-vaccination, after prime and boost vaccinations and assessed by comparing titers at
the two dose levels as well as the two routes of administration. In addition, viremia
deriving from the attenuated vaccine viruses will be measured on days 0 (baseline), 2, 4,
5/6, 7, 9, 11, and 14 after both prime and boost vaccinations. Levels of neutralizing
antibodies will also be measured in samples to be obtained on days 180 and 270 for analysis
and submission in a supplement to the study report. This study will enroll 72 healthy
flavivirus-negative male and female subjects between the ages of 18 and 45.
We found this trial at
1
site
Click here to add this to my saved trials
