Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.

开始日期2018-10-03

申办/合作机构

MMV Medicines for Malaria Venture

[+1]

PACTR201712002879427

/ SuspendedN/AIIT

Randomized, placebo-controlled, double-blind, three-arm, clinical trial to assess safety, tolerability and protective efficacy of PfSPZ-CVac and PfSPZ Vaccine in 1-12 years old African children naturally exposed to malaria parasites

开始日期2018-03-01

申办/合作机构-

NCT03083847

/ Completed临床1期IIT

Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Dose Escalation Trial to Determine Safety and Development of Protective Efficacy After Exposure to Only Pre-erythrocytic Stages of Plasmodium Falciparum

Background:
People get malaria from bites from infected mosquitos. Researchers are studying a vaccine strategy. They will give people malaria parasites by injecting them with live infectious malaria parasites with antimalarial medications and then see if this strategy prevents malaria infection while off antimalarial medications.
Objective:
To see if combining a high dose of live, infectious malaria parasites (known as Sanaria PfSPZ Challenge) and two FDA approved drugs that kill malaria parasites (pyrimethamine [PYR] OR chloroquine [CQ]) is safe and can provide people protection against malaria.
Eligibility:
Healthy adults ages 18-50 who:
are not pregnant or breastfeeding or planning on becoming pregnant while in the study
are not infected with HIV, Hepatitis B or Hepatitis C
have reliable early morning access to the NIH Clinical Center
are able to come to the outpatient clinic frequently, sometimes daily
have not been diagnosed with malaria within the past 10 years
Design:
Participants will be screened with medical history and physical exam. They will have heart, blood, and urine tests.
Participants will have blood drawn for tests at most visits.
Participants will keep track of their temperature and symptoms during some sections of the study.
Participants will join one part of the study.
Part 1 is one month:
Participants will get the parasites by an injection into a vein on day 1 and receive antimalarial medications.
They will have daily visits on days 7-14
They will take another antimalarial at visits on days 15-17.
The final visit will be on day 29.
Part 2 is seven months:
For the first 3 months, participants will get the parasite injection into a vein for 3 injections in total. Each injection will occur once per month while taking an antimalarial drug.
They will have daily visits on days 7-14 after the first injection, and on days 7-11 after the second and third injection.
They will have a final (fourth) injection around month 6 without any antimalarial medication.
After this fourth injection, participants may have up to 21 daily visits from day 7 after injection until end of study.
Part 3 is one month:
Participants will get the parasites by injection into a vein on day 1 without antimalarial medications.
They will have visits almost every day starting day 7 from injection.
They will take an antimalarial medication when they are diagnosed with malaria
They will return for final end of study visit on days 27-29.

开始日期2017-06-05

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

100 项与 DSM-265 相关的临床结果

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100 项与 DSM-265 相关的转化医学

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100 项与 DSM-265 相关的专利（医药）

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135

项与 DSM-265 相关的文献（医药）

2024-12-01·LANCET INFECTIOUS DISEASES

Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials

Article

作者: Issiaka, Djibrilla ; Doan, Viyada ; Dicko, Alassane ; Doritchamou, Justin Y A ; Wang, Jing ; Richie, Thomas L ; Rausch, Kelly M ; Hoffman, Stephen L ; Soumbounou, Ibrahim H ; Kc, Natasha ; Billingsley, Peter F ; Traore, Seydou ; Dolo, Amagana ; Gaoussou, Santara ; Mwakingwe-Omari, Agnes ; Fried, Michal ; Duffy, Patrick E ; Mahamar, Almahamoudou ; Sim, B Kim Lee ; Murshedkar, Tooba ; Attaher, Oumar ; Hu, Zonghui ; Diawara, Halimatou ; Healy, Sara A ; Diallo, Aye ; Morrison, Robert D ; Zeguime, Amatigue ; Zaidi, Irfan ; Mohan, Rathy ; Wylie, Blair J

BACKGROUND:

Plasmodium falciparum parasitaemia during pregnancy causes maternal, fetal, and infant mortality. Poor pregnancy outcomes are related to blood-stage parasite sequestration and the ensuing inflammatory response in the placenta, which decreases over successive pregnancies. A radiation-attenuated, non-replicating, whole-organism vaccine based on P falciparum sporozoites (PfSPZ Vaccine) has shown efficacy at preventing infection in African adults. Here, we aimed to examine vaccine safety and efficacy of the PfSPZ Vaccine in adults and women who anticipated conception.

METHODS:

Two randomised, double-blind, placebo-controlled trials (phase 1 MLSPZV3 and phase 2 MLSPZV4) were conducted at a clinical research centre in Mali. MLSPZV3 included adults aged 18-35 years and MLSPZV4 included non-pregnant women aged 18-38 years who anticipated conception within a year of enrolment. In MLSPZV3, participants were stratified by village and randomly assigned (2:1) using block randomisation to receive three doses of 9 × 10⁵ PfSPZ Vaccine or saline placebo at weeks 0, 1, and 4 (4-week schedule) or at weeks 0, 8, and 16 (16-week schedule) and a booster dose around 1 year later. In MLSPZV4, women received presumptive artemether-lumefantrine twice per day for 3 days 2 weeks before dose one and were randomly assigned (1:1:1) using block randomisation to receive three doses of 9 × 10⁵ or 1·8 × 10⁶ PfSPZ Vaccine or saline placebo all administered at weeks 0, 1, and 4 (4-week schedule). Participants in both studies received artemether-lumefantrine 2 weeks before dose three and additionally 2 weeks before dose four (booster dose) in MLSPZV3. Investigators and participants were masked to group assignment. The primary outcome, assessed in the as-treated population, was PfSPZ Vaccine safety and tolerability within 7 days after each dose. The secondary outcome, assessed in the modified intention-to-treat population, was vaccine efficacy against P falciparum parasitaemia (defined as the time-to-first positive blood smear) from dose three until the end of transmission season. In exploratory analyses, MLSPZV4 evaluated incidence of maternal obstetric and neonatal outcomes as safety outcomes, and vaccine efficacy against P falciparum parasitaemia during pregnancy (defined as time-to-first positive blood smear post-conception). In MLSPZV4, women were followed at least once a month with human chorionic gonadotropin testing, and those who became pregnant received standard of care (including intermittent presumptive sulfadoxine-pyrimethamine antimalarial drugs after the first trimester) during routine antenatal visits. These studies are registered with ClinicalTrials.gov, NCT03510481 and NCT03989102.

FINDINGS:

Participants were enrolled for vaccination during the onset of malaria seasons for two sequential studies conducted from 2018 to 2019 for MLSPZV3 and from 2019 to 2021 for MLSPZV4, with follow-up during malaria seasons across 2 years. In MLSPZV3, 478 adults were assessed for eligibility, of whom 220 were enrolled between May 30 and June 12, 2018, and then between Aug 13 and Aug 18, 2018, and 210 received dose one. 66 (96%) of 69 participants who received the 16-week schedule and 68 (97%) of 70 who received the 4-week schedule of the 9 × 10⁵ PfSPZ Vaccine and 70 (99%) of 71 who received saline completed all three doses in year 1. In MLSPZV4, 407 women were assessed for eligibility, of whom 324 were enrolled from July 3 to July 27, 2019, and 320 received dose one of presumptive artemether-lumefantrine. 300 women were randomly assigned with 100 per group (PfSPZ Vaccine 9 × 10⁵, 1·8 × 10⁶, or saline) receiving dose one. First trimester miscarriages were the most commonly reported serious adverse event but occurred at a similar rate across study groups (eight [15%] of 54 with 9 × 10⁵ PfSPZ Vaccine, 12 [21%] of 58 with 1·8 × 10⁶ PfSPZ Vaccine, and five [12%] of 43 with saline). One unrelated maternal death occurred 425 days after the last vaccine dose in the 1·8 × 10⁶ PfSPZ Vaccine group due to peritonitis shortly after childbirth. Most related adverse events reported in MLSPZV3 and MLSPZV4 were mild (grade 1) and frequency of adverse events in the PfSPZ Vaccine groups did not differ from that in the saline group. Two unrelated serious adverse events occurred in MLSPZV3 (one participant had appendicitis in the 9 × 10⁵ PfSPZ Vaccine group and the other in the saline group died due to a road traffic accident). In MLSPZV3, the 9 × 10⁵ PfSPZ Vaccine did not show vaccine efficacy against parasitaemia with the 4-week (27% [95% CI -18 to 55] in year 1 and 42% [-5 to 68] in year 2) and 16-week schedules (16% [-34 to 48] in year 1 and -14% [-95 to 33] in year 2); efficacies were similar or worse against clinical malaria compared with saline. In MLSPZV4, the PfSPZ Vaccine showed significant efficacy against parasitaemia at doses 9 × 10⁵ (41% [15 to 59]; p=0·0069 in year 1 and 61% [36 to 77]; p=0·0011 in year 2) and 1·8 × 10⁶ (54% [34 to 69]; p<0·0001 in year 1 and 45% [13 to 65]; p=0·029 in year 2); and against clinical malaria at doses 9 × 10⁵ (47% [20 to 65]; p=0·0045 in year 1 and 56% [22 to 75]; p=0·0081 in year 2) and 1·8 × 10⁶ (48% [22 to 65]; p=0·0013 in year 1 and 40% [2 to 64]; p=0·069 in year 2). Vaccine efficacy against post-conception P falciparum parasitaemia during first pregnancies that arose in the 2-year follow-up was 57% (14 to 78; p=0·017) in the 9 × 10⁵ PfSPZ Vaccine group versus 49% (3 to 73; p=0·042) in the 1·8 × 10⁶ PfSPZ Vaccine group. Among 55 women who became pregnant within 24 weeks after dose three, vaccine efficacy against parasitaemia was 65% (23 to 84; p=0·0088) with the 9 × 10⁵ PfSPZ Vaccine and 86% (64 to 94; p<0·0001) with the 1·8 × 10⁶ PfSPZ Vaccine. When combined in a post-hoc analysis, women in the PfSPZ Vaccine groups had a non-significantly reduced time-to-first pregnancy after dose one compared with those in the saline group (log-rank test p=0·056). Exploratory maternal obstetric and neonatal outcomes did not differ significantly between vaccine groups and saline.

INTERPRETATION:

PfSPZ Vaccine was safe and well tolerated in adults in Mali. The 9 × 10⁵ and 1·8 × 10⁶ doses of PfSPZ Vaccine administered as per the 4-week schedule, which incorporated presumptive antimalarial treatment before the first vaccine dose, showed significant efficacy against P falciparum parasitaemia and clinical malaria for two malaria transmission seasons in women of childbearing age and against pregnancy malaria. PfSPZ Vaccine without presumptive antimalarial treatment before the first vaccine dose did not show efficacy.

FUNDING:

National Institute of Allergy and Infectious Diseases, National Institutes of Health, and Sanaria.

2024-10-01·JOURNAL OF INFECTION

Antibodies to PfEMP1 and variant surface antigens: Protection after controlled human malaria infection in semi-immune Kenyan adults

Article

作者: Kapulu, Melissa C. ; Abdi, Abdirahman I ; Kinyanjui, Samson M. ; Kapulu, Melisa C. ; Andisi, Cheryl ; Kapulu, Melissa C ; Kinyua, Ann W ; Kimingi, Hannah W ; Sim, B Kim Lee ; Turner, Louise ; Lavstsen, Thomas ; Bejon, Philip ; Kinyanjui, Samson M ; Mwai, Kennedy ; Sim, B. Kim Lee ; Abdi, Abdirahman I. ; Mwikali, Kioko ; Kimingi, Hannah W. ; Kinyua, Ann W.

OBJECTIVES:

Acquisition of antibodies to Plasmodium falciparum variant surface antigens (VSA) expressed on infected red blood cells (iRBCs) is associated with naturally acquired immunity to malaria. We have previously shown that antibodies to VSA on iRBCs are associated with protection against parasite growth in the context of controlled human malaria infection (CHMI). This study explored whether antibodies to recombinant antigens derived from PfEMP1 domains were independently associated with protection during CHMI in semi-immune Kenyan adults.

METHODS:

We used a multiplex bead assay to measure levels of IgG antibody against a panel of 27 recombinant PfEMP1 antigens derived from the PfEMP1 repertoire of the 3D7 parasite clone. We measured IgG levels in plasma samples collected from the CHMI participants before inoculation with Sanaria® PfSPZ Challenge, on the day of diagnosis, and 35 days post-inoculation. Univariable and multivariable Cox regression analysis was used to evaluate the relationship between the levels of antibodies to the antigens and CHMI outcome. We also adjusted for previous data including antibodies to VSA on iRBCs, and we assessed the kinetics of antibody acquisition to the different PfEMP1 recombinant antigens over time.

RESULTS:

All study participants had detectable antibodies to multiple PfEMP1 proteins before inoculation. All PfEMP1 antigens were associated with protection against parasite growth to the threshold criteria for treatment in CHMI, albeit with substantial collinearity. However, individual PfEMP1 antigens were not independently associated with protection following adjustment for breadth of reactivity to VSA on iRBCs and schizont extract. In addition, antibodies to PfEMP1 antigens derived from group B PfEMP1 were induced and sustained in the participants who could not control parasite growth.

CONCLUSION:

This study shows that the breadth of antibody response to VSA on iRBCs, and not to specific PfEMP1 antigens, is predictive of protection against malaria in CHMI.

2024-06-10·JCI Insight

Innate immune activation restricts priming and protective efficacy of the radiation-attenuated PfSPZ malaria vaccine

Article

作者: Upadhye, Aditi ; Simpson, Edward ; Little, Morgan R ; Schmidt, Nathan W ; Oneko, Martina ; Steinhardt, Laura C ; Gaskin, Erik L ; Polidoro, Rafael B ; Yamamoto, Ayako ; Liu, Xiaowen ; Oblak, Adrian L ; Hoffman, Stephen L ; Bhardwaj, Jyoti ; Fusco, Elizabeth M ; Haining, W Nicholas ; Otieno, Kephas ; Richie, Thomas L ; Kariuki, Simon ; Senkpeil, Leetah ; Flynn, Barbara J ; Xuei, Xiaoling ; Sim, B Kim Lee ; Murshedkar, Tooba ; Yates, Kathleen B ; Holla, Prasida ; Wiegand, Ryan E ; Swanson, Phillip A ; Sather, D Noah ; Seder, Robert A ; Gao, Hongyu ; Liu, Yunlong ; Macklin, Michael D ; Tran, Tuan M ; Bi, Kevin

A systems analysis was conducted to determine the potential molecular mechanisms underlying differential immunogenicity and protective efficacy results of a clinical trial of the radiation-attenuated whole-sporozoite PfSPZ vaccine in African infants. Innate immune activation and myeloid signatures at prevaccination baseline correlated with protection from P. falciparum parasitemia in placebo controls. These same signatures were associated with susceptibility to parasitemia among infants who received the highest and most protective PfSPZ vaccine dose. Machine learning identified spliceosome, proteosome, and resting DC signatures as prevaccination features predictive of protection after highest-dose PfSPZ vaccination, whereas baseline circumsporozoite protein-specific (CSP-specific) IgG predicted nonprotection. Prevaccination innate inflammatory and myeloid signatures were associated with higher sporozoite-specific IgG Ab response but undetectable PfSPZ-specific CD8+ T cell responses after vaccination. Consistent with these human data, innate stimulation in vivo conferred protection against infection by sporozoite injection in malaria-naive mice while diminishing the CD8+ T cell response to radiation-attenuated sporozoites. These data suggest a dichotomous role of innate stimulation for malaria protection and induction of protective immunity by whole-sporozoite malaria vaccines. The uncoupling of vaccine-induced protective immunity achieved by Abs from more protective CD8+ T cell responses suggests that PfSPZ vaccine efficacy in malaria-endemic settings may be constrained by opposing antigen presentation pathways.

项与 DSM-265 相关的新闻（医药）

2024-08-14

·drugs

Candidate Malaria Vaccine Provides Lasting Protection in NIH-Sponsored Trials

August 14, 2024 -- Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy. Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum ( Pf ), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year. The trials were co-led by investigators from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the University of Sciences, Techniques and Technologies, Bamako (USTTB), Mali. The investigational vaccine used in both trials was PfSPZ Vaccine, a radiation-attenuated vaccine based on Pf sporozoites (a stage of the parasite’s lifecycle), manufactured by Sanaria Inc., Rockville, Maryland. Multiple previous clinical trials of PfSPZ Vaccine have shown it to be safe, including in malaria-endemic countries such as Mali. In results published in 2022, for example, an NIAID-sponsored, placebo-controlled trial of a three-dose regimen of PfSPZ Vaccine in Burkina Faso found that the vaccine had up to 46% efficacy that lasted at least 18 months. In the first year of the current trial, 55 women became pregnant within 24 weeks of the third vaccine dose. Among these women, vaccine efficacy against parasitemia (whether before or during pregnancy) was 65% in those who received the lower dose vaccine and 86% in those who received the higher dose. Among 155 women who became pregnant across both study years, vaccine efficacy was 57% for those who received lower dose vaccine and 49% in those in the higher dosage group. Women who received the investigational vaccine at either of the dosages conceived sooner than those who received placebo, although this finding did not reach the level of statistical significance, reported the investigators. The researchers speculate that the PfSPZ Vaccine might avert malaria-related early pregnancy losses since parasitemia risk during the periconception period was reduced by 65 to 86%. “Preconception immunization is a new strategy to reduce mortality for women with malaria in pregnancy,” the researchers note. They plan to investigate the safety of PfSPZ Vaccine administered during pregnancy, then examine the efficacy of PfSPZ given preconception or during pregnancy in larger clinical trials. “Existing measures are not protecting women from malaria in pregnancy,” they added. “A safe and effective vaccine is urgently needed, and our results indicate PfSPZ Vaccine might be a suitable candidate,” they conclude. The PfSPZ Vaccine Study Team was led by Alassane Dicko, M.D., of the Malaria Research and Training Center (MRTC), USTTB, Mali, Stephen L. Hoffman, M.D., of Sanaria Inc., and Patrick E. Duffy, M.D., of the NIAID Laboratory of Malaria Immunology and Vaccinology. Joint co-first authors were Halimatou Diawara, M.D., of MRTC, and Sara A. Healy, M.D., NIAID. Additional information about the trials is available at clinicaltrials.gov using the identifiers NCT03510481 or NCT03989102. H Diawara et al. Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials . Lancet Infectious Diseases DOI: 10.1016/ S1473-3099(24)00360-8 (2024). Patrick E. Duffy, M.D., Chief, Laboratory of Malaria Immunology and Vaccinology, NIAID, is available to comment. To schedule interviews, please contact Anne A. Oplinger, (301) 402-1663, niaidnews@niaid.nih.gov . NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website . About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. Source: NIH Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

疫苗临床结果临床1期

2024-08-14

·sanaria.com

First-of-its-kind vaccine expands malaria protection for pregnant women

On August 14th, 2024, The Lancet Infectious Diseases released a publication entitled: "Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials."Read More In a report published on March 21, 2024 in EMBO Molecular Medicine (A replication competent Plasmodium falciparum parasite completely attenuated by dual gene deletion) investigators at Seattle Children’s Research Institute and Sanaria Inc. describe the development of a whole malaria parasite vaccine strain that infects the liver, develops to the late liver stage, and then gets completely stuck and cannot burst out of the liver to cause symptomatic blood infection.Read More Sanaria receives $1.5M from the Gates Foundation to make PfSPZ Challenge more accessible for future controlled human malaria infections (CHMIs) in the form of a repository.Read More Scientists from Sanaria Inc., and collaborators at multiple institutions publish results in Nature reporting “In vitro production of infectious Plasmodium falciparum sporozoites.”Read More ROCKVILLE, MD, USA – July 12, 2022 – 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.Read More Sanaria Inc. announces that two new Phase 2 trials of its pioneering malaria vaccines have started. The first is in 6- to 10-year-old children living in Bancoumana, Mali, a malarious region of West Africa. The second is in Indonesian soldiers based in Sumatra, Indonesia. The soldiers will be deploying for six to nine months this coming August to an intensely malarious district in eastern Indonesia.Read More Sanaria Inc. and Seattle Children’s Research Institute are proud to announce the signing of an agreement to collaborate on the development and commercialization of next generation PfSPZ vaccines attenuated by genetic engineering.Read More 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. This is the first time complete protection against a variant malaria parasite has ever been achieved that long after vaccine administration.Read More Sanaria and its collaborators have had to take a step by step empirical approach to optimizing immunization with PfSPZ vaccines to achieve a safe, effective, durable, and broadly protective malaria vaccine. Two recent landmark malaria vaccine studies have moved the optimization process forward and highlighted the strong protective efficacy of Sanaria® PfSPZ-CVac in malaria-naïve adults. Read More Sanaria to receive €12.9M for the development of two Malaria vaccines, one Malaria prophylactic, and a SARS-CoV-2 vaccine from the EU Malaria Fund.Read More USPTO awards Sanaria with the 2020 Patents for Humanity Award for Sanaria's malaria vaccine.Read More Sanaria Inc. and the Government of Equatorial Guinea last week signed an agreement that continues their joint commitment to develop Sanaria® PfSPZ Vaccine as a tool for malaria elimination. This follows a new, broader agreement between the Government of Equatorial Guinea (EG) and industry partners, Marathon Oil Corporation, Noble Energy Inc. and Atlantic Methanol Production Company (AMPCO), to sponsor clinical development of Sanaria® PfSPZ Vaccine, including the Phase 3 clinical program starting in 2020. This long standing, successful partnership highlights the unique involvement of an African government and private-sector energy companies in developing a vaccine for a largely African problem.Read More Building upon publication of clinical trial results in Nature, PNAS, Lancet Infectious Diseases, and JCI Insight in 2017, Sanaria Inc. is highlighting the work of its many collaborators at a symposium entitled “Moving Toward a PfSPZ Malaria Vaccine for Protecting Travelers and Use in Elimination Campaigns” (session 133) at the 66th meeting of the American Society of Tropical Medicine and Hygiene in Baltimore, and then at the second 2017 International PfSPZ Consortium meeting held at the University of Maryland School of Medicine.Read More In a report published today in the Proceedings of the National Academy of Sciences, investigators from the National Institute of Allergy and Infectious Diseases (NIAID), NIH and the University of Maryland School of Medicine reported that nine of fourteen subjects (64%) immunized with three doses of Sanaria® PfSPZ Vaccine were protected against homologous challenge with Plasmodium falciparum malaria 19 weeks after their last vaccine dose. 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.Read More In a report published today in The Lancet Infectious Diseases, investigators reported that Sanaria® PfSPZ Vaccine protected against natural infections of Plasmodium falciparum, the leading cause of malaria deaths and that protection was sustained for the 24 weeks of the study in an area of intense malaria transmission.Read More In a report published today in Nature, 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. Professor Peter Kremsner, MD, Director of the Institute of Tropical Medicine at the University, led the clinical team.Read More Sanaria Inc. continues to achieve success in its coordinated efforts to develop a safe, effective and affordable vaccine that delivers mass malaria protection in humans and promotes elimination of the disease worldwide. 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 reports that Sanaria® PfSPZ Vaccine protected against Plasmodium falciparum malaria when clinical trial participants were exposed to two strains of parasites.Read More 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. Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.Read More Results of a clinical trial of Sanaria® PfSPZ (Plasmodium falciparum sporozoite) Vaccine to prevent malaria infections, published today in the online issue of Nature Medicine magazine, show that the vaccine provided protection against infection with malaria parasites for at least 14 months in subjects who were exposed to Plasmodium falciparum parasites. The findings put the Sanaria vaccine on track to be the first malaria vaccine providing durable protection against infection with malaria parasites. Plasmodium falciparum is the malaria parasite that causes about 438,000 deaths and 214 million cases annually.Read More The Government of the Republic of Equatorial Guinea announced an agreement with industry partners, Marathon Oil Corporation, Noble Energy Inc. and AMPCO, to sponsor the clinical development of Sanaria® PfSPZ Vaccine against malaria, including a series of clinical trials from 2015 until 2018.Read More

疫苗临床2期临床结果临床1期快速通道

2023-01-04

·Science Daily

A three-dose malaria vaccine shows safety, efficacy in West African adults

A three-dose regimen of a whole-parasite vaccine against malaria -- called Plasmodium falciparum sporozoite (PfSPZ) vaccine -- demonstrated safety and efficacy when tested in adults living in Burkina Faso, West Africa, which has endemic malaria. A three-dose regimen of a whole-parasite vaccine against malaria -- called Plasmodium falciparum sporozoite (PfSPZ) vaccine -- demonstrated safety and efficacy when tested in adults living in Burkina Faso, West Africa, which has endemic malaria. That is the finding of a new study published on Dec. 7, 2022, in Science Translational Medicine. Researchers at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health (CVD) led the work. About 241 million people worldwide were infected with malaria in 2020, and 627,000 people died from their infections. Scientists have tried for decades to develop a highly effective malaria vaccine without much success. That is because the vaccines have been shown not to provide much protection in those who have already been infected with malaria earlier in life due to their acquired immunity. The first vaccine against malaria (RTS,S/AS01) was approved by the World Health Organization in October 2021, and it provides modest protection against malaria. The new study involved 80 participants in a randomized controlled clinical trial comparing three doses of the PfSPZ vaccine against a placebo. At six months follow up, vaccine efficacy was up to 48 percent; at 18 months follow up, vaccine efficacy was up to 46 percent. "Our study shows that the vaccine can be given to malaria-experienced adults in a highly endemic area and still provide protection, which is difficult and complicated as these individuals already have significant immune responses to malaria parasites that must be overcome by a vaccine for it to be successful," said study corresponding author Matthew B. Laurens, MD, MPH, Professor of Pediatrics at UMSOM and Director, International Clinical Trials Unit in the Malaria Research Group at CVD. PfSPZ Vaccine is made with a live-attenuated form of the malaria parasite Plasmodium falciparum sporozoite, which is transmitted by mosquitos. The vaccine is made by Rockville, Maryland-based Sanaria Inc. and has been shown to provide at least 90-percent protection in challenge studies where volunteers are infected with malaria (in a highly controlled way); these studies were conducted by CVD researchers in the U.S. and by other groups in Tanzania. In African adults who previously had malaria, PfSPZ provided 52 percent vaccine efficacy against naturally transmitted malaria infection. Protection lasted 8 to 14 months. In the new study, researchers wanted to reduce the number of required injections from five shots to three, while improving vaccine efficacy. They assessed safety, tolerability, immunogencity, and vaccine efficacy of three injections of the vaccine in a two-part study. The first part enrolled 32 adults in a dose-escalation phase in 2016 and the second enrolled 80 adults in a randomized trial in 2017. In the randomized trial, 39 received PfSPZ Vaccine and 41 received placebo. Study participants were healthy men and non-pregnant women ages 21 to 40. The vaccines were well tolerated and without concerning side effects. "New strategies are needed to achieve the United Nations sustainable development goal of a 90-percent reduction in malaria incidence and mortality by 2030," said UMSOM DeanMark T. Gladwin, MD, Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor. "Innovative vaccines that provide a higher level of protection against malaria are urgently needed to help to achieve this goal." Additional co-authors on the newly published research from UMSOM's Center for Vaccine Development and Global Health include: Kirsten E. Lyke, MD, Professor of Medicine; Sudhaunshu Joshi, MS, Laboratory Specialist; Biraj Shrestha, Laboratory Assistant; and Kathy Strauss, Laboratory Specialis. The new study reflects a long history of malaria vaccine development at UMSOM that started in the early 1970s with landmark research from David Clyde, MD, former head of malarial studies at CVD. His studies demonstrated that high-level protection against malaria infection is possible using a whole organism vaccine. Future research includes conducting additional clinical trials of the PfSPZ Vaccine in groups that would benefit most from vaccine-induced protection, including children, travelers, military personnel, and pregnant women. Many of these studies are underway, including an ongoing trial at UMSOM to administer a compressed schedule of three doses of PfSPZ Vaccine in one month, which is a feasible timeline for travelers and military populations. Results of this study are expected in 2023. The study was funded by NIH's National Institute of Allergy and Infectious Diseases grants U01AI112367 and 5R44AI055229.

临床结果疫苗上市批准

100 项与 DSM-265 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
恶性疟	临床2期	秘鲁	MMV Medicines for Malaria Venture	2016-01-01
间日疟原虫感染	临床2期	秘鲁	MMV Medicines for Malaria Venture	2016-01-01
疟疾	临床2期	澳大利亚	Clinical Network Services Pty Ltd.	2015-02-01
疟疾	临床2期	澳大利亚	Q-Pharm Pty Ltd.	2015-02-01
虫血症	临床1期	比利时	MMV Medicines for Malaria Venture	2020-02-19
三日疟	临床1期	美国	MMV Medicines for Malaria Venture	2016-03-01
鲍氏不动杆菌感染	临床前	美国	The NewYork-Presbyterian Healthcare System, Inc.	2022-12-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02573857 \| NCT02389348 (Pubmed \| J Antimicrob Chemother)	临床1/2期	恶性疟	-	OZ439 800mg + DSM265 450mg	壓衊艱鏇遞簾淵觸鑰壓(壓顧醖膚餘鬱鏇繭鹽遞) = 淵艱壓繭構壓築鬱壓窪鬱觸憲糧餘窪餘餘鑰繭 (構夢築廠顧願鹽構膚築 )	-	2021-06-28
NCT02450578 (CTgov)	临床1期	恶性疟	22	Placebo to DSM265 400 mg+DSM265 400mg (Cohort 1a: DSM265/Placebo, Sporozoite Inoculum)	鑰積獵餘膚獵願鹽衊餘(淵蓋製齋範範願繭選鑰) = 壓鏇糧網鏇艱鏇築壓衊積範選築願壓齋齋製繭 (顧積鑰餘鏇鹹夢蓋壓網, 淵蓋鑰繭顧鏇齋選衊淵 ~ 選顧網憲壓簾築構鹹蓋)	-	2020-12-03
				Placebo to DSM265 400 mg+DSM265 400mg (Cohort 2: DSM265/Placebo, Sporozoite Inoculum)	鑰積獵餘膚獵願鹽衊餘(淵蓋製齋範範願繭選鑰) = 壓築淵築鹹築選願積醖積範選築願壓齋齋製繭 (顧積鑰餘鏇鹹夢蓋壓網, 衊艱窪憲壓夢衊鏇積積 ~ 齋鏇襯夢壓願鹽淵膚鑰)
NCT02573857 (DSMOZ-2, CTgov)	临床1/2期	疟疾	16	DSM265 (DSM265 P. Falciparum)	衊範膚壓簾鏇選築壓襯(廠餘繭鑰築鹽餘壓醖醖) = 顧繭憲遞選蓋壓膚鬱淵鏇壓鑰夢餘顧獵鬱窪願 (餘鬱繭膚廠衊壓製醖窪, 鏇選壓觸膚餘醖廠網壓 ~ 衊齋壓簾鏇製襯範選網) 更多	-	2020-06-05
				OZ439 (OZ439 P. Vivax)	衊範膚壓簾鏇選築壓襯(廠餘繭鑰築鹽餘壓醖醖) = 獵衊鏇願構壓觸夢衊遞鏇壓鑰夢餘顧獵鬱窪願 (餘鬱繭膚廠衊壓製醖窪, 鬱遞齋窪襯膚夢鏇網顧 ~ 廠夢築齋艱糧觸襯選鏇) 更多
NCT03637517 (CTgov)	临床1期	疟疾	42	DSM265 25% SDD, 400 mg fasted (DSM265 25% SDD, 400 mg Fasted)	構鬱製糧餘繭製餘淵襯(壓觸蓋鏇餘糧構積襯壓) = 壓網繭艱鹽顧鏇衊鏇艱簾餘壓築廠衊範壓築衊 (遞獵鹹觸製壓繭夢夢衊, 壓選壓餘鏇獵範艱襯選 ~ 繭築鏇網窪淵獵壓廠鏇) 更多	-	2020-03-11
				DSM265-TPGS 34% SDD, 400 mg fasted (DSM265-TPGS 34% SDD, 400 mg Fasted)	構鬱製糧餘繭製餘淵襯(壓觸蓋鏇餘糧構積襯壓) = 衊觸製築窪簾願鑰遞餘簾餘壓築廠衊範壓築衊 (遞獵鹹觸製壓繭夢夢衊, 鑰鹹製壓鬱鑰鹹顧簾積 ~ 蓋壓積積糧鹽憲獵壓餘) 更多
NCT02389348 (Pubmed \| Antimicrob Agents Chemother) 人工标引	临床1/2期	恶性疟	13	Artefenomel+DSM265 (Cohort 1)	鹽夢繭窪願製獵鹹齋鬱(廠簾餘選鬱構齋壓積鑰) = 衊憲選鹹膚築鹽繭襯選壓廠廠糧鏇夢醖顧醖製 (壓壓築遞艱鏇獵艱壓廠 ) 更多	积极	2019-12-20
				Artefenomel+DSM265 (Cohort 2)	鹽夢繭窪願製獵鹹齋鬱(廠簾餘選鬱構齋壓積鑰) = 顧膚顧淵鑰醖願鑰構築壓廠廠糧鏇夢醖顧醖製 (壓壓築遞艱鏇獵艱壓廠 ) 更多
NCT02123290 (Pubmed \| Lancet Infect Dis)	临床2期	间日疟原虫感染	45	400 mg DSM265	鬱獵築糧壓築壓築憲願(夢餘齋醖衊夢壓觸糧夢) = 廠積觸鑰繭構夢夢選窪構製築憲餘簾獵顧簾憲 (範齋鏇壓範簾範淵積顧 ) 更多	-	2018-08-01
				250 mg DSM265	鬱獵築糧壓築壓築憲願(夢餘齋醖衊夢壓觸糧夢) = 餘鹹蓋製衊鹽廠衊築選構製築憲餘簾獵顧簾憲 (範齋鏇壓範簾範淵積顧 ) 更多