Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNA vaccine prime · 1 trial · 1 indication
The vaccine will be considered safe and well-tolerated if there are no severe or serious adverse events (AE) related to vaccine administration or if any severe events are relatively benign (e.g. erythema meeting criteria for severe due to its dimensions but not significantly affecting the activities of daily living for the subject) or brief in duration (e.g. less than 48 hours). The AEs will be assessed according to the method below. 1. Occurrence, severity, and duration of any solicited symptoms starting on the day of immunization through day 7 after each immunization 2. Occurrence of any unsolicited symptoms, abnormal physical findings, and laboratory values starting from the day of immunization through day 28 after each immunization 3. Occurrence of any serious adverse events, as defined in 21 CFR 312.32, during the five-year study period
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | DNA vaccine prime Given at 0, 4, and 8 weeks |
| 2 | EXPERIMENTAL | adenovirus type 5 vaccine boost Given at 24 weeks |
| Name | Type | Description |
|---|---|---|
| DNA vaccine prime | BIOLOGICAL | 2 mg total dose (1 mg per construct in a volume of 1 mL) |
| adenovirus type 5 vaccine boost | BIOLOGICAL | 2 x 1010 particle units (pu) (1 x 1010 pu per each of 2 constructs including CSP and AMA1 respectively) |
Inclusion Criteria: * Healthy adults 18 to 50 years of age (inclusive) * Women who are not pregnant by a current negative pregnancy test or of non-childbearing potential * Willing to use an FDA approved birth control method including condoms, birth control pills, sterility surgery, or intrauterine ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
DNA vaccine prime is an investigational vaccine being studied for the prevention of malaria. It is currently in Phase 1 clinical development and is not yet approved for use. The vaccine is designed to generate an immune response against the malaria parasite.
DNA vaccine prime is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity.
DNA vaccine prime is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety, immune response, and protective efficacy against malaria.
DNA vaccine prime has been studied in one completed Phase 1 clinical trial, identified as NCT00870987. This trial, titled 'Clinical Trial for Malaria Vaccines to Test for Safety, Immune Response and Protection Against Malaria,' enrolled 82 participants in the United States.
DNA vaccine prime is classified as a monoclonal antibody modality in the development pipeline. However, it is being investigated as a vaccine to prevent malaria, and its mechanism of action involves eliciting an immune response rather than directly targeting a specific molecular target.