Drugs / PfSPZ Vaccine
PfSPZ Vaccine
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT05652504 | Sep 2026 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 1 | NCT04966871 | Sep 2021 → Jun 2022 | Plasmodium falciparum malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03590340 | Jul 2018 → Mar 2019 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03510481 | May 2018 → Nov 2019 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT03420053 | Feb → Aug 2018 | Plasmodium falciparum malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03163121 | May 2017 → Oct 2018 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02859350 | Nov 2016 → Dec 2017 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02663700 | Apr 2016 → Dec 2018 | Plasmodium falciparum malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02627456 | Dec 2015 → Mar 2018 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02613520 | Dec 2015 → Feb 2017 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02418962 | Mar → Sep 2015 | Plasmodium falciparum malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02215707 | Jun 2014 → Apr 2015 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02132299 | Apr 2014 → Jul 2015 | Plasmodium falciparum malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02015091 | Dec 2013 → May 2015 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01988636 | Oct 2013 → Aug 2015 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01001650 | Apr 2009 → Jul 2010 | Plasmodium falciparum malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT02687373 | Jul 2016 → Aug 2018 | malaria | Sanaria Inc. | Completed | Missed primary |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03503058 | May 2022 → Feb 2024 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03989102 | Jul 2019 → Apr 2022 | Plasmodium falciparum malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT03521973 | Jun 2018 → May 2021 | malaria | Sanaria Inc. | Completed | Missed primary |
| Phase 2 | NCT02601716 | Jan 2016 → Sep 2017 | malaria | Sanaria Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05604521 Comparator | Dec 2022 → Sep 2023 | Plasmodium falciparum malaria | Sanaria Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-08-14 | Sanaria Inc. | Results First-of-its-kind vaccine expands malaria protection for pregnant women sanaria.com ↗
Sanaria ® PfSPZ Vaccine protects women against malaria before and during pregnancy for at least two years |
| 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 ↗
Using two identical regimens to immunize US and Malian adults, VE over 24 weeks in the field was as good as or better than VE against Pf7G8 CHMI at 24 weeks in the US. |
| 2021-06-30 | Sanaria Inc. | Results SANARIA VACCINE TRIAL RESULTS DEMONSTRATE UNPRECEDENTED PROGRESS IN WORLDWIDE BATTLE AGAINST VARIANT MALARIA PARASITES sanaria.com ↗
This is the first time complete protection against a variant malaria parasite has ever been achieved that long after vaccine administration. |
| 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 ↗
While a staggering 93% of the placebo group had one or more infections, only 66% of the vaccinated subjects acquired an infection and in those vaccinated subjects who became infected, the time to infection was delayed. |
| 2017-02-15 | Sanaria Inc. | Results Sanaria’s PfSPZ-CVac Vaccine Achieves High Level Protection Against Malaria in Clinical Trial sanaria.com ↗
PfSPZ-CVac was administered to the nine subjects three times over eight weeks; the research demonstrated the three doses were also safe and effective when administered over just 10 days. |
| 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 ↗
Research published today in JCI Insight by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research led by Capt. Judith Epstein, M.C., and Maj. Kris Paolino, M.D., reports that Sanaria® PfSPZ Vaccine protected against Plasmodium falciparum malaria when clinical trial participants were exposed to two strains of parasites. |
| 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 ↗
These results show that we have a safe, successful, injectable vaccine that has the potential to save millions of lives. |
| 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 20 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PFSPZ Vaccine | “Dose Escalation Study of Sanaria's Irradiated Sporozoite Vaccine (PFSPZ Vaccine), Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial” NCT02663700 ↗22“Clinical Trial of the PfSPZ Vaccine” NCT01001650 ↗ |
| Known as | PfSPZ | “PfSPZ is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.” NCT02663700 ↗ |
| Known as | Plasmodium falciparum sporozoite Vaccine | “Sanaria® PfSPZ Vaccine (Plasmodium falciparum sporozoite Vaccine) is being developed for this purpose.” PMID 29141739 ↗ Jan 2018 |
| Known as | Sanaria PfSPZ Vaccine | “USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess...” NCT05604521 ↗2“Sanaria PfSPZ Vaccine, composed of attenuated Plasmodium falciparum (Pf) sporozoites (SPZ), protects against malaria.” PMID 38194272 ↗ Jan 2024 “Sanaria® PfSPZ Vaccine (Plasmodium falciparum sporozoite Vaccine) is being developed for this purpose.” PMID 29141739 ↗ Jan 2018 |
| Modality | Vaccine | “a non-replicating, metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine” NCT01001650 ↗ |
| Route | Subcutaneous | “PfSPZ Vaccine Administered Subcutaneously or Intradermally” NCT01001650 ↗ |