At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1 Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine
In Brief
A Phase 1 clinical trial evaluating rDEN3Δ30/31-7164 for Response To Dengue Exposure. Completed, enrolled 127 participants across 1 site.
Signals
Detailed 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, dengue vaccines are limited and do not protect all people equally. One vaccine actually increased the risk of severe disease in some people and was taken off the market. 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.
Study Details
Timeline
Arms & Interventions
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Interventions
The rDEN3Δ30/31-7164 vaccine is a live attenuated virus constructed by creating two deletions in the 3' untranslated region (UTR) of the DENV-3 Sleman/78 strain. The vaccine dose consists of 0.5 mL of 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 plus Plasma-Lyte A pH 7.4 diluent delivered subcutaneously into the deltoid area on day 0.