Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-29 @ 11:48 AM
Study NCT ID:
NCT01110551
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2010-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tetravalent Chimeric Dengue Vaccine Trial
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| N01AI80003C | None | None | View |