Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322049
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2006-05-03
Brief Title:
A Phase III Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase III Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants
Status:
COMPLETED
Status Verified Date:
2017-12
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:
The main target populations for the tetravalent live attenuated dengue virus vaccine are indigenous populations especially infants less than 2 years old residing in areas of the world endemic for dengue and at risk of developing dengue hemorrhagic fever DHF The presence of maternal dengue antibody during the first year of life makes it unlikely that a vaccine given during that time will have long-term efficacy as the vaccine virus would likely be neutralized prior to necessary replication Children older than 18 months may have preexisting flavivirus antibody Therefore vaccination of infants living in Thailand early in the second year of life between the ages of 12 and 18 months seems most beneficial The aim of this trial is to evaluate the safety and immunogenicity of a two-dose schedule of a tetravalent live attenuated dengue vaccine in flavivirus antibody naïve infants beginning at 12-15 months of age
To assess the kinetics of dengue neutralizing antibodies to each dengue virus serotype one and four years following dose 2 of denguecontrol vaccination in the setting of potential wild-type dengue virus exposure
To assess the immunogenicity the safety and reactogenicity of a booster dose of dengue vaccine administered at Year 3 following primary vaccination
To assess the kinetics of dengue neutralizing antibodies to each dengue virus serotype one and four years following dose 2 of denguecontrol vaccination in the setting of potential wild-type dengue virus exposure
To assess the immunogenicity the safety and reactogenicity of a booster dose of dengue vaccine administered at Year 3 following primary vaccination
Detailed Description:
This is a Phase III randomized observer-blind controlled trial Thirty-four flavivirus naïve infants will be randomized to the vaccine group and 17 infants to the control group
Infants receive dengue vaccine at study months 0 and 6 or control vaccine Varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6 Both are licensed for use in Thailand
All infants subsequently receive an inactivated JE vaccine approximately one and 15 months following dengue vaccine dose 2
Infants are monitored daily for 21 days following each dengue or control vaccination and 7 days after each JE vaccination for solicited adverse events Unsolicited events will be recorded up to 31 days days 0-30 after denguecontrol vaccinations and each day after dose 1 of JE vaccine until the concluding study visit
Study duration excluding screening is approximately 85 months for each subject
Each enrollee is followed a four year period following dose 2 of denguecontrol vaccination to assess for dengue-related hospitalizations and dengue antibody kinetics
Investigators will administer a 3rd dose of tetravalent dengue vaccine to all subjects who received 2 doses of dengue vaccine 0 and 6 months during the primary phase of the study The 3rd dose will be administered 3 years following the primary vaccination series Peripheral blood mononuclear cells PBMCs and sera will be collected at the time of dose 3 and twice again at one month and one year following dose 3 from dengue group subjects
Investigators will address the following questions
1 Is a 3rd dose of live virus tetravalent dengue vaccine safe in Thai toddlerschildren
2 Is a 3rd dose of live virus tetravalent dengue vaccine required in toddlerschildren to induce optimal immune neutralizing antibody cellular mediated immunity responses
3 Is there evidence of T and B cell memory following a primary dengue vaccination series dose 1 and 2
4 How does a 3rd dose of live virus tetravalent dengue vaccine impact B and T cell memory
Infants receive dengue vaccine at study months 0 and 6 or control vaccine Varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6 Both are licensed for use in Thailand
All infants subsequently receive an inactivated JE vaccine approximately one and 15 months following dengue vaccine dose 2
Infants are monitored daily for 21 days following each dengue or control vaccination and 7 days after each JE vaccination for solicited adverse events Unsolicited events will be recorded up to 31 days days 0-30 after denguecontrol vaccinations and each day after dose 1 of JE vaccine until the concluding study visit
Study duration excluding screening is approximately 85 months for each subject
Each enrollee is followed a four year period following dose 2 of denguecontrol vaccination to assess for dengue-related hospitalizations and dengue antibody kinetics
Investigators will administer a 3rd dose of tetravalent dengue vaccine to all subjects who received 2 doses of dengue vaccine 0 and 6 months during the primary phase of the study The 3rd dose will be administered 3 years following the primary vaccination series Peripheral blood mononuclear cells PBMCs and sera will be collected at the time of dose 3 and twice again at one month and one year following dose 3 from dengue group subjects
Investigators will address the following questions
1 Is a 3rd dose of live virus tetravalent dengue vaccine safe in Thai toddlerschildren
2 Is a 3rd dose of live virus tetravalent dengue vaccine required in toddlerschildren to induce optimal immune neutralizing antibody cellular mediated immunity responses
3 Is there evidence of T and B cell memory following a primary dengue vaccination series dose 1 and 2
4 How does a 3rd dose of live virus tetravalent dengue vaccine impact B and T cell memory
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 |
|---|---|---|---|
| DEN-001 | OTHER | GSK | None |
| HSRRB Log A-10064 | OTHER | None | None |
| GSK CPMS7663310001 | OTHER | None | None |