Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rDEN2delta30-7169 · 1 trial · 3 indications
Evaluate the safety of the challenge strain in all groups.
Evaluate viral replication by qRT-PCR and compare the peak replication among groups.
Evaluate the immunogenicity of the challenge by examining the change in antibody titers in each group.
| Arm | Type | Description |
|---|---|---|
| Heterotypic | EXPERIMENTAL | Those with their highest titer to a non-DENV2. |
| Homotypic | EXPERIMENTAL | Those with a DENV2-dominant serotype. |
| Naive | EXPERIMENTAL | Those with no exposures to flaviviruses |
| Name | Type | Description |
|---|---|---|
| rDEN2delta30-7169 | BIOLOGICAL | The rDEN2delta30-7169 strain is a live attenuated recombinant virus constructed by introducing a 30-nucleotide deletion (delta30) in 3 UTR of the wild type DEN-2 Tonga/74. |
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Aged 18 to 50 years. 2. In good general health as evidenced by medical history, physical examination, and laboratory screening results 3. Willing to allow storage of samples an...
rDEN2delta30-7169 is an investigational monoclonal antibody being studied in healthy volunteers for use in a human challenge trial to evaluate host-pathogen interactions in primary, homotypic, and heterotypic dengue virus infection. It is currently in Phase 1 clinical development for infectious disease research.
rDEN2delta30-7169 is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting a Phase 1 clinical trial of the investigational agent in the United States.
rDEN2delta30-7169 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The ongoing Phase 1 trial is currently recruiting participants in the United States.
rDEN2delta30-7169 is being studied in one Phase 1 clinical trial, NCT07706686, titled 'Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection.' The trial is recruiting 200 healthy volunteers in the United States.
Yes, rDEN2delta30-7169 is a monoclonal antibody. It is being investigated as a challenge agent in a controlled human infection model to study dengue virus infection in healthy volunteers.