Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691530
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-01-19
Brief Title:
Trial to Model Primary Secondary and Tertiary Dengue Using a Monovalent Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase 1 Trial to Model Primary Secondary and Tertiary Dengue Using a Monovalent Vaccine
Status:
RECRUITING
Status Verified Date:
2024-10-01
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:
Background
Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America and outbreaks have occurred in the US Currently only one vaccine is licensed for dengue but it only protects people who have had dengue before In people who have never had dengue that vaccine increases the risk of severe disease Better vaccines are needed
Objectives
To test a potential new vaccine against dengue To see if side effects and immune responses are different depending on a person s previous exposure to dengue
Eligibility Healthy people aged 18 to 59 years
Design
Participants will visit the clinic 11 times in 7 months 9 of those visits will be in the first 2 months Two additional visits are optional
Participants will be screened They will have a physical exam with urine and blood tests They will complete a survey about their travel history
Participants may opt to have a lymph node aspiration before receiving the study vaccine An area in the left armpit will be numbed A needle will be inserted to remove some cells from a lymph node
The vaccine will be injected into the fat under the skin of the participant s upper left arm
Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks Then they will return for a provider visit and blood draws after longer intervals up to 7 months The lymph node aspiration may be repeated at later visits
Participants may opt to return for a last visit after 12 months
Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America and outbreaks have occurred in the US Currently only one vaccine is licensed for dengue but it only protects people who have had dengue before In people who have never had dengue that vaccine increases the risk of severe disease Better vaccines are needed
Objectives
To test a potential new vaccine against dengue To see if side effects and immune responses are different depending on a person s previous exposure to dengue
Eligibility Healthy people aged 18 to 59 years
Design
Participants will visit the clinic 11 times in 7 months 9 of those visits will be in the first 2 months Two additional visits are optional
Participants will be screened They will have a physical exam with urine and blood tests They will complete a survey about their travel history
Participants may opt to have a lymph node aspiration before receiving the study vaccine An area in the left armpit will be numbed A needle will be inserted to remove some cells from a lymph node
The vaccine will be injected into the fat under the skin of the participant s upper left arm
Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks Then they will return for a provider visit and blood draws after longer intervals up to 7 months The lymph node aspiration may be repeated at later visits
Participants may opt to return for a last visit after 12 months
Detailed Description:
Study Description
Phase 1 trial wherein healthy adults with no naive one primary heterotypic or more than one polytypic previous natural dengue virus DENV infections will be immunized with the DENV3 monovalent vaccine rDEN3delta3031-7164 We aim to examine how pre-vaccine host immunity influences the safety and immunogenicity of monovalent DENV3 vaccination in a non-endemic population We hypothesize that the vaccine will be safe and well tolerated and all groups will have evidence of infection with the vaccine strain as indicated by a significant increase in the DENV neutralizing antibody geometric mean titer GMT between days 0 and 28 However due to the immunity conferred by prior dengue exposures the polytypic group will have the lowest and the heterotypic group will have the highest mean peak viremia indicating protection and enhancement respectively Additionally the polytypic group will have the strongest CD8 T-cell responses at day 15 and will only have a transient rise in GMT with no difference in GMT between days 0 and 57 In contrast the change in GMT will persist at day 57 in the heterotypic and naive groups Finally we expect that prior immunity will influence the vaccine response as evidenced by a significant association between the day 0 GMT and GMT at days 28 and 57
Primary Objective
Evaluate the safety of monovalent DENV3 vaccination in those with distinct natural DENV infection histories living in non-endemic areas and how prior DENV immunity influences protection against vaccine strain infection evaluated by the change in GMT and mean peak viremia
Secondary Objective
Further evaluate how DENV infection history impacts the immunogenicity of the vaccine
Primary Endpoints
1 The frequency and severity of local and systemic reactogenicity signs and symptoms during the 28-day period after each vaccination unexpected adverse events AEs up to 28 days after each vaccination and serious adverse events SAEs through day 180
2 Change in DENV neutralizing antibody GMT between days 0 and 28
3 Mean peak viremia among groups as measured by viral quantitative reverse transcription polymerase chain reaction qRT-PCR between days 3 and 15
Secondary Endpoints
1 Change in DENV neutralizing antibody GMT between days 0 and 57
2 DENV neutralizing antibody GMT at days 0 28 and 57
3 Magnitude of the CD8 T-cell response at day 15 among groups as measured by activation-induced marker AIM assays
Phase 1 trial wherein healthy adults with no naive one primary heterotypic or more than one polytypic previous natural dengue virus DENV infections will be immunized with the DENV3 monovalent vaccine rDEN3delta3031-7164 We aim to examine how pre-vaccine host immunity influences the safety and immunogenicity of monovalent DENV3 vaccination in a non-endemic population We hypothesize that the vaccine will be safe and well tolerated and all groups will have evidence of infection with the vaccine strain as indicated by a significant increase in the DENV neutralizing antibody geometric mean titer GMT between days 0 and 28 However due to the immunity conferred by prior dengue exposures the polytypic group will have the lowest and the heterotypic group will have the highest mean peak viremia indicating protection and enhancement respectively Additionally the polytypic group will have the strongest CD8 T-cell responses at day 15 and will only have a transient rise in GMT with no difference in GMT between days 0 and 57 In contrast the change in GMT will persist at day 57 in the heterotypic and naive groups Finally we expect that prior immunity will influence the vaccine response as evidenced by a significant association between the day 0 GMT and GMT at days 28 and 57
Primary Objective
Evaluate the safety of monovalent DENV3 vaccination in those with distinct natural DENV infection histories living in non-endemic areas and how prior DENV immunity influences protection against vaccine strain infection evaluated by the change in GMT and mean peak viremia
Secondary Objective
Further evaluate how DENV infection history impacts the immunogenicity of the vaccine
Primary Endpoints
1 The frequency and severity of local and systemic reactogenicity signs and symptoms during the 28-day period after each vaccination unexpected adverse events AEs up to 28 days after each vaccination and serious adverse events SAEs through day 180
2 Change in DENV neutralizing antibody GMT between days 0 and 28
3 Mean peak viremia among groups as measured by viral quantitative reverse transcription polymerase chain reaction qRT-PCR between days 3 and 15
Secondary Endpoints
1 Change in DENV neutralizing antibody GMT between days 0 and 57
2 DENV neutralizing antibody GMT at days 0 28 and 57
3 Magnitude of the CD8 T-cell response at day 15 among groups as measured by activation-induced marker AIM assays
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 001078-I | None | None | None |