Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375726
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2006-09-12
Brief Title:
Safety of and Immune Response to a Dengue Virus Vaccine rDEN34delta30ME in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase 1 Study of the Safety and Immunogenicity of rDEN34delta30ME a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
Status:
COMPLETED
Status Verified Date:
2010-12
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:
Dengue fever caused by dengue viruses is a major health problem in the tropical and subtropical regions of the world The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults
Detailed Description:
Dengue viruses which cause dengue fever and dengue shock syndrome are a major cause of morbidity and mortality in several of the worlds tropical and subtropical regions The rDEN34delta30ME vaccine is a live attenuated dengue virus vaccine that may be protective against dengue virus serotype 3 DEN3 The purpose of this study is to evaluate the safety and immunogenicity of the rDEN34delta30ME vaccine in healthy adults
This study will last 40 weeks Participants will be randomly assigned to receive one of three doses of rDEN34delta30ME or placebo Participants in Group 1 will receive the middle dose of rDEN34delta30ME or placebo at study entry Group 2a will begin enrollment after the immunogenicity review of all participants in Group 1 Participants in Group 2a will receive the highest dose of rDEN4delta30ME or placebo at study entry Group 2b will begin enrollment after the immunogenicity review of all participants in Group 2a Participants in Group 2b will receive the lowest dose of rDEN4delta30ME or placebo
After vaccination participants in all groups will be followed closely every other day for the first 16 days of the study Participants will take their temperature three times a day through Day 16 and record each measurement in a diary After Day 16 participants will have study visits on Days 21 28 42 and 180 a physical exam and blood collection will occur at all visits Some participants may be asked to join a skin biopsy substudy
This study will last 40 weeks Participants will be randomly assigned to receive one of three doses of rDEN34delta30ME or placebo Participants in Group 1 will receive the middle dose of rDEN34delta30ME or placebo at study entry Group 2a will begin enrollment after the immunogenicity review of all participants in Group 1 Participants in Group 2a will receive the highest dose of rDEN4delta30ME or placebo at study entry Group 2b will begin enrollment after the immunogenicity review of all participants in Group 2a Participants in Group 2b will receive the lowest dose of rDEN4delta30ME or placebo
After vaccination participants in all groups will be followed closely every other day for the first 16 days of the study Participants will take their temperature three times a day through Day 16 and record each measurement in a diary After Day 16 participants will have study visits on Days 21 28 42 and 180 a physical exam and blood collection will occur at all visits Some participants may be asked to join a skin biopsy substudy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB Protocol Number 20061667 | None | None | None |