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NMRC-M3V-Ad-PfCA · 1 trial · 1 indication
To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a dose-escalation design (Part A), in healthy malaria-naïve adults. Part A was a dose escalation of NMRC-M3V-AdPfCA (2 antigen combination) using two dose groups, 2x10\^10 pu (Group 1) and 1x10\^11 pu (Group 2). Subjects received a single intramuscular injection with the injections in the 2 groups staggered by 4 weeks in order to assess the safety and tolerability of the vaccine and define the dose to be used in Part B. The vaccine was to be considered safe and well-tolerated if there were no severe or serious adverse events related to vaccine administration.
To assess the safety and tolerability of NMRC-M3V-Ad-PfCA, in a regimen-comparison design (Part B), in healthy malaria-naïve adults. Subjects in part B received 2 intramuscular injections given 16 weeks apart: Group 3 NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu, or Group 4 NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose. The vaccine was to be considered safe and well-tolerated if there were no severe or serious adverse events related to vaccine administration.
Protective efficacy was assessed by conducting a homologous 3D7 strain sporozoite challenge 3 weeks after the second NMRCMV-Ad-PfC immunization. Time to parasitemia was measured in both vaccinated and unvaccinated volunteers (infectivity controls) in Group 3 (NMRC-M3V-Ad-PfCA (2 antigen combination) at a dose of 2x10\^10 pu) and Group 4 (NMRC-MV-Ad-PfC (single antigen) at 1x10\^10 pu dose). Infectivity control subjects were challenged with Group 3 and Group 4. Each volunteer was monitored for the onset of signs and symptoms of malaria and by daily Giemsa-stained thick blood films with positive films confirmed by a second reader. The identity of immunized and non-immunized volunteers was known to the clinical trial staff but not to the microscopists reading the malaria smears.
| Arm | Type | Description |
|---|---|---|
| Dose-escalation | EXPERIMENTAL | NMRC-M3V-Ad-PfCA |
| Regimen-comparison | EXPERIMENTAL | NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA |
| Name | Type | Description |
|---|---|---|
| NMRC-M3V-Ad-PfCA | BIOLOGICAL | Malaria Vaccine |
| NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA | BIOLOGICAL | Malaria Vaccines |
INCLUSION CRITERIA: * Between the ages of 18-50 (inclusive) * Negative results of HIV ELISA, HbSAg, anti-HCV antibody, and no other clinically significant abnormal laboratory results from screening. * Adenovirus serotype 5 (Ad5) titer \<1:500 * Able to provide written informed consent. * Complete a...
NMRC-M3V-Ad-PfCA is an investigational monoclonal antibody being developed for Plasmodium falciparum, the parasite that causes malaria. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied for its potential to prevent or treat this infection.
NMRC-M3V-Ad-PfCA is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on this investigational drug for Plasmodium falciparum.
NMRC-M3V-Ad-PfCA is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 clinical trial has been completed, and the drug remains in early-stage clinical testing for Plasmodium falciparum.
NMRC-M3V-Ad-PfCA has one completed Phase 1 clinical trial, identified as NCT00392015. This trial enrolled 59 participants in the United States, including healthy volunteers aged 18 years and older. The study was controlled but not double-blinded, and it evaluated the drug for Plasmodium falciparum.
No, NMRC-M3V-Ad-PfCA is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Plasmodium falciparum. The drug has completed one Phase 1 trial but remains in early-stage testing and has not yet received regulatory approval.