Drugs / PfSPZ
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01441167 | Sep 2011 → Jun 2013 | Plasmodium falciparum malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2024-08-14 | Sanaria Inc. | Results First-of-its-kind vaccine expands malaria protection for pregnant women sanaria.com ↗
For the first time, immunization with a malaria vaccine has been shown to protect mothers from malaria during pregnancy and to protect for two transmission seasons without booster doses of vaccine. |
| 2022-12-07 | Sanaria Inc. | Results INFECTIOUS MALARIA SPOROZOITES PRODUCED WITHOUT MOSQUITOES PROVIDE GROUND-BREAKING PROGRESS FOR MALARIA VACCINES AND BIOLOGY RESEARCH sanaria.com ↗
Scientists from Sanaria Inc., and collaborators at multiple institutions publish results in Nature reporting “ In vitro production of infectious Plasmodium falciparum sporozoites.” |
| 2022-07-26 | Sanaria Inc. | Results COLLABORATORS PUBLISH ARTICLE IN NATURE COMMUNICATIONS: PLASMODIUM FALCIPARUM 7G8 CHALLENGE PROVIDES CONSERVATIVE PREDICTION OF EFFICACY OF PFNF54-BASED PFSPZ VACCINE IN AFRICA sanaria.com ↗
Sanaria Inc., University of Maryland School of Medicine, Naval Medical Research Center, National Institutes of Health (USA), University of Bamako Malaria Research and Training Center (Mali), and University of Tübingen (Germany) published results in Nature Communications showing Plasmodium falciparum 7G8 human challenge trials provide a conservative prediction of efficacy of PfNF54-based PfSPZ Vaccine in Africa. |
| 2021-06-30 | Sanaria Inc. | Results SANARIA VACCINE TRIAL RESULTS DEMONSTRATE UNPRECEDENTED PROGRESS IN WORLDWIDE BATTLE AGAINST VARIANT MALARIA PARASITES sanaria.com ↗
In an article published today in Nature, Sanaria’s PfSPZ-CVac (CQ) vaccine is reported as being safe and protecting 100% of six subjects against a variant malaria parasite three months after their last dose in the company’s Phase 1 safety and efficacy trial. |
| 2021-06-08 | Sanaria Inc. | Results Optimizing immunization with Sanaria® PfSPZ-CVac malaria vaccine sanaria.com ↗
We have demonstrated excellent efficacy with just three co-administrations of PfSPZ-CVac and chloroquine, paving the way for a product that can be used for travelers worldwide. |
| 2017-02-20 | Sanaria Inc. | Results Sanaria’s PfSPZ Vaccine Achieves Durable Protection Against Heterologous Malaria Infection in a Clinical Trial sanaria.com ↗
Moreover, five of six of the protected subjects who underwent a subsequent heterologous challenge with Plasmodium falciparum 33 weeks after their last vaccine dose were protected. |
| 2017-02-15 | Sanaria Inc. | Results Sanaria’s PfSPZ Vaccine Confers Significant Protection Against Natural Malaria infections in Mali sanaria.com ↗
This represents 48% protective efficacy by time-to-event analysis and 29% efficacy by proportional analysis. |
| 2017-02-15 | Sanaria Inc. | Results Sanaria’s PfSPZ-CVac Vaccine Achieves High Level Protection Against Malaria in Clinical Trial sanaria.com ↗
investigators from the University of Tübingen reported all nine subjects (100%) immunized with three doses of Sanaria® PfSPZ-CVac malaria vaccine in a recently completed clinical trial were protected against Plasmodium falciparum malaria when exposed to the disease 10 weeks after last vaccine dose. |
| 2017-01-12 | Sanaria Inc. | Results Sanaria’s PfSPZ Vaccine Provides High-Level Defense Against Malaria In U.S. Navy and Army Clinical Investigation sanaria.com ↗
Furthermore, protection was achieved with just three doses of the vaccine and against a strain of parasite similar to one in the vaccine for at least 24 weeks. |
| 2016-09-22 | Sanaria Inc. | Regulatory Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation sanaria.com ↗
Rockville, MD – Sanaria Inc. today announced it has received U.S. Food and Drug Administration (FDA) Fast Track designation for its preventative vaccine for malaria, Sanaria® PfSPZ Vaccine. |
| 2016-05-06 | Sanaria Inc. | Results Sanaria’s Malaria Vaccine Yields Unprecedented Protection In Clinical Trial sanaria.com ↗
The findings put the Sanaria vaccine on track to be the first malaria vaccine providing durable protection against infection with malaria parasites. |
| 2013-08-08 | Sanaria Inc. | Results Sanaria’s Malaria Vaccine Yields Unprecedented Protection In Phase 1 Clinical Trial sanaria.com ↗
Results of a phase I clinical trial of the Sanaria® PfSPZ Vaccine to combat malaria, published today in the online issue of Science magazine, show that the vaccine provided complete protection against malaria in subjects who were exposed to Plasmodium falciparum parasites. |
| 2011-09-08 | Sanaria Inc. | Results Initial Trial Of Sanaria’s Malaria Vaccine Yields Positive Results sanaria.com ↗
Positive results from the initial Phase 1 clinical trial in 80 healthy volunteers and complementary pre-clinical studies of the Sanaria® PfSPZ Vaccine are published today in the online issue of Science ( www.sciencexpress.org ). |
All press releases naming this drug 21 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PfSPZ | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01441167 ↗ |
| Known as | PfSPZ Vaccine | “The investigational PfSPZ Vaccine is manufactured by Sanaria, Inc (Rockville, MD) under current Good Manufacturing Practices (cGMP).” NCT01441167 ↗ |
| Modality | Vaccine | “The investigational PfSPZ Vaccine is manufactured by Sanaria, Inc (Rockville, MD) under current Good Manufacturing Practices (cGMP).” NCT01441167 ↗ |
| Route | Intravenous | “administered by the IV route” NCT01441167 ↗ |