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Cancer Vaccine
RNA Vaccine for Malaria
Phase 1 & 2
Waitlist Available
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
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 moreSecondary 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
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.
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BioNTech SELead Sponsor
77 Previous Clinical Trials
115,688 Total Patients Enrolled
1 Trials studying Malaria
60 Patients Enrolled for Malaria
BioNTech Responsible PersonStudy DirectorBioNTech SE
38 Previous Clinical Trials
11,271 Total Patients Enrolled
1 Trials studying Malaria
60 Patients Enrolled for Malaria