What is the mechanism of action of this treatment?

Common treatments for malaria include antimalarial drugs such as chloroquine, artemisinin-based combination therapies (ACTs), and primaquine. Chloroquine works by interfering with the parasite's ability to detoxify heme, leading to its death. ACTs combine artemisinin, which generates reactive oxygen species to damage the parasite, with other drugs to reduce resistance. Primaquine targets the liver stage of the parasite, preventing relapse. These treatments are crucial as they target different stages of the parasite's lifecycle, reducing the likelihood of resistance and ensuring comprehensive eradication. The investigational RNA-based vaccine BNT165e, which encodes P. falciparum antigens encapsulated in lipid nanoparticles, aims to elicit an immune response to prevent infection, representing a proactive approach compared to the reactive nature of drug treatments.

What side effects are associated with this type of intervention?

Common treatments for malaria include antimalarial drugs such as artemisinin-based combination therapies (ACTs), chloroquine, and newer investigational treatments like RNA-based vaccines. Side effects of ACTs can include nausea, vomiting, dizziness, and allergic reactions. Chloroquine may cause gastrointestinal disturbances, headaches, and in rare cases, retinopathy. RNA-based vaccines, like the investigational BNT165e, may have side effects similar to other mRNA vaccines, including injection site reactions, fever, fatigue, and muscle pain. Severe side effects are rare but can include allergic reactions.

What prior FDA approvals exist?

There are no specific FDA-approved RNA-based vaccines for malaria similar to the investigational BNT165e vaccine. Traditional FDA-approved treatments for malaria include antimalarial drugs such as chloroquine, artemisinin-based combination therapies (ACTs), and primaquine. These treatments target the asexual blood stages of the parasite or prevent relapse in the case of P. vivax and P. ovale. The development of RNA-based vaccines like BNT165e represents a novel approach, focusing on eliciting immune responses against P. falciparum antigens.

What other types of research exist?

Promising alternatives to the BNT165e RNA-based vaccine for malaria include the R21/Matrix-M vaccine, which has shown high efficacy in Phase II trials, and the PfSPZ vaccine, which uses live, attenuated sporozoites and has demonstrated strong protective effects in clinical studies. Both vaccines are in advanced stages of development and offer different mechanisms of action compared to the RNA-based BNT165e.

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Cancer Vaccine

RNA Vaccine for Malaria

Phase 1 & 2

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days after each dose

Summary

This trial tests a new vaccine designed to prevent malaria in healthy adults who have never had the disease. The vaccine helps the immune system recognize and fight malaria.

Who is the study for?

Healthy adults aged 18-55 who haven't been to malaria regions recently, don't have HIV or hepatitis, and aren't pregnant can join this trial. They should be able to follow the study's rules and not be in another drug study at the same time.

What is being tested?

The trial is testing BNT165e, an experimental RNA-based vaccine for preventing malaria. It uses three RNAs with malaria proteins inside lipid particles. Participants will either get this vaccine or a placebo (a harmless substance).

What are the potential side effects?

Possible side effects are not detailed here but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 days after each dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 days after each dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days after each dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of participants in each cohort with at least one serious adverse event occurring until 24 weeks after Dose 3

Frequency of participants with at least one adverse event occurring until 28 days after each dose

Frequency of participants with at least one medically attended adverse event occurring until 24 weeks after Dose 3

+2 more

Secondary study objectives

Descriptive statistics on antibody levels at assessed timepoints

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BNT165eExperimental Treatment1 Intervention

Escalating dose levels

Group II: PlaceboPlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for malaria include antimalarial drugs such as chloroquine, artemisinin-based combination therapies (ACTs), and primaquine. Chloroquine works by interfering with the parasite's ability to detoxify heme, leading to its death. ACTs combine artemisinin, which generates reactive oxygen species to damage the parasite, with other drugs to reduce resistance. Primaquine targets the liver stage of the parasite, preventing relapse. These treatments are crucial as they target different stages of the parasite's lifecycle, reducing the likelihood of resistance and ensuring comprehensive eradication. The investigational RNA-based vaccine BNT165e, which encodes P. falciparum antigens encapsulated in lipid nanoparticles, aims to elicit an immune response to prevent infection, representing a proactive approach compared to the reactive nature of drug treatments.

Physicochemical investigation and in vivo activity of anti-malarial drugs co-loaded in Tween 80 niosomes.Efficacy and safety of methylene blue in the treatment of malaria: a systematic review.