Employee of the Month: Urvashi Rai

The Sanaria employee of the month for May, 2022 is Urvashi Rai. Urvashi is a member of the Vaccine Extraction and Model Systems team and was nominated for employee of the month for her outstanding efforts to create, train, and maintain an exclusive taskforce at Sanaria called the "Part-time Vaccine extraction specialists."

Employees of the Month: Liza Torres-Alvarado, Shachi Shah, and Mei Chen

The Sanaria employees of the month for June 201 are Liza Torres-Alvarado, Shachi Shah, and Mei Chen. Liza is our Office Associate, Shachi is a member of the regulatory team, and Mei is a member of the clinical team. Liza and Shachi were nominated for employees of the month for their work on the Master File for the mixed diluent submission to the FDA. Mei was nominated for employee of the month for her preparation work and support of Sanaria’s clinical trial in Malian children.

Dose-Dependent Infectivity of Aseptic, Purified, Cryopreserved Plasmodium falciparum 7G8 Sporozoites in Malaria-Naive Adults

We conducted a double-blind, randomized, dose-escalation study to assess the infectivity of the 7G8 clone of Pf (PfSPZ Challenge [7G8]). Results showed dose-dependent infectivity from 43% for 8 × 102 PfSPZ to 100% for 4.8 × 103 PfSPZ. PfSPZ Challenge (7G8) will allow for more complete assessment by CHMI of antimalarial vaccines and drugs.

Controlled Human Malaria Infection of Healthy Adults With Lifelong Malaria Exposure to Assess Safety, Immunogenicity, and Efficacy of the Asexual Blood Stage Malaria Vaccine Candidate GMZ2

GMZ2 is well tolerated and immunogenic in lifelong-Pf-exposed adults from Gabon, with similar antibody responses regardless of formulation. CHMI showed no protective effect of prior vaccination with GMZ2, although baseline, vaccine-specific antibody concentrations were associated with protection. CHMI with the PfSPZ Challenge is a potent new tool to validate asexual, blood-stage malaria vaccines in Africa.

Serologic markers of previous malaria exposure and functional antibodies inhibiting parasite growth are associated with parasite kinetics following a Plasmodium falciparum controlled human infection

Abstract

BACKGROUND:

We assessed the impact of exposure to P. falciparum on parasite kinetics, clinical symptoms, and functional immunity after controlled human malaria infection (CHMI) in two cohorts with different levels of previous malarial exposure.

METHODS:

Nine adult males with high (sero-high) and ten with low (sero-low) previous exposure received 3200 PfSPZ of PfSPZ Challenge by direct venous inoculation and were followed for 35 days for parasitemia by thick blood smear (TBS) and quantitative polymerase chain reaction (qPCR). End points were time to parasitemia, adverse events and immune responses.

RESULTS:

Ten of Ten (100%) volunteers in the sero-low and 7 |

Controlled human malaria infection with Plasmodium falciparum demonstrates impact of naturally acquired immunity on virulence gene expression

Abstract

The pathogenesis of Plasmodium falciparum malaria is linked to the variant surface antigen PfEMP1, which mediates tethering of infected erythrocytes to the host endothelium and is encoded by approximately 60 var genes per parasite genome. Repeated episodes of malaria infection result in the gradual acquisition of protective antibodies against PfEMP1 variants. The antibody repertoire is believed to provide a selective pressure driving the clonal expansion of parasites expressing unrecognized PfEMP1 variants, however, due to the lack of experimental in vivo models there is only limited experimental evidence in support of this concept. To get insight into the impact of |

Is Saglin a mosquito salivary gland receptor for Plasmodium falciparum?

Abstract

BACKGROUND:

Saglin, a 100 kDa protein composed of two 50 kDa homodimers, is present in the salivary glands of Anopheles gambiae and has been considered an essential receptor for sporozoites (SPZ) of Plasmodium berghei and Plasmodium falciparum (Pf), allowing SPZ to recognize, bind to, and infect mosquito salivary glands. Spatial and temporal patterns of Saglin expression reported here, however, suggest that this model does not fully describe the Saglin-SPZ interaction.

RESULTS:

Saglin protein was detected by indirect immunofluorescence microscopy only in the medial and proximal-lateral lobes, but not in the distal-lateral lobes, of the salivary glands of An. gambiae; the pattern |

Artemisinin resistance phenotypes and K13 inheritance in a Plasmodium falciparum cross and Aotus model

Abstract

Concerns about malaria parasite resistance to treatment with artemisinin drugs (ARTs) have grown with findings of prolonged parasite clearance t 1/2s (5 h) and their association with mutations in Plasmodium falciparum Kelch-propeller protein K13. Here, we describe a P. falciparum laboratory cross of K13 C580Y mutant with C580 wild-type parasites to investigate ART response phenotypes in vitro and in vivo. After genotyping 400 isolated progeny, we evaluated 20 recombinants in vitro: IC50 measurements of dihydroartemisinin were at similar low nanomolar levels for C580Y- and C580-type progeny (mean ratio, 1.00; 95% CI, 0.62-1.61), whereas, in a ring-stage |

Sanaria’s malaria vaccines clinical and manufacturing progress highlighted at International meetings in Baltimore

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.

Sanaria’s PfSPZ Vaccine Achieves Durable Protection Against Heterologous Malaria Infection in a Clinical Trial

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.

Sanaria’s PfSPZ Vaccine Confers Significant Protection Against Natural Malaria infections in Mali

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.

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