What side effects are associated with this type of intervention?

Common treatments for malaria include artemether-lumefantrine, which has a high treatment success rate but can cause side effects such as headache, dizziness, and gastrointestinal disturbances. Serious adverse events are rare, occurring in about 1.3-1.4% of patients. For RNA-based vaccines like BNT165b1, which are designed to elicit an immune response against malaria, specific side effects are not well-documented yet. However, RNA vaccines in general can cause side effects such as injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea.

What prior FDA approvals exist?

The FDA has not yet approved any RNA-based vaccines specifically for malaria. Traditional FDA-approved treatments for malaria include antimalarial drugs like chloroquine, artemisinin-based combination therapies (ACTs), and atovaquone-proguanil. These treatments primarily target the parasite during its blood stage. The investigational RNA-based vaccine BNT165b1 represents a novel approach, aiming to elicit an immune response against the Plasmodium falciparum circumsporozoite protein, which is a different strategy compared to the existing antimalarial drugs.

What other types of research exist?

Promising alternatives to BNT165b1 for malaria treatment in 2024 include: 1) R21/Matrix-M, a protein-based malaria vaccine that has shown high efficacy in phase 2 trials; 2) Monoclonal antibodies such as CIS43LS, which have demonstrated potential in providing protection against malaria; 3) Tafenoquine, a novel antimalarial drug effective in preventing relapse of Plasmodium vivax malaria. These alternatives represent significant advancements in malaria prevention and treatment.

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RNA-based Vaccine

RNA Vaccine for Malaria

Phase 1

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 5 years

Awards & highlights

Summary

This trial tests a new RNA-based vaccine called BNT165b1 in healthy volunteers. The vaccine uses genetic instructions to help the body make a piece of the malaria parasite's protein, teaching the immune system to recognize and fight malaria.

Who is the study for?

Healthy adults aged 18-55, with a BMI of 18.5-35 kg/m^2 and weighing at least 45 kg can join this malaria vaccine trial. They must have no history of severe allergies to vaccines, autoimmune diseases, or uncontrolled respiratory conditions. Participants should not be pregnant or planning pregnancy soon, agree to use effective contraception, and avoid traveling to malaria regions during the study.

What is being tested?

The trial is testing BNT165b1, an RNA-based vaccine for malaria prevention. It's given in three doses at different strengths to find the safest and most effective dose level. A placebo group is included for comparison.

What are the potential side effects?

Possible side effects may include typical reactions seen with other vaccines such as pain at the injection site, fatigue, headache, muscle pain, chills or fever. Since it's investigational, there might be unknown risks that will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BNT165b1Experimental 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 and vaccines designed to elicit an immune response. Antimalarial drugs, such as artemisinin-based combination therapies (ACTs), work by targeting the parasite at different stages of its lifecycle, effectively reducing parasitemia and preventing disease progression. Vaccines like the investigational BNT165b1, which uses RNA-lipid nanoparticles to encode parts of the Plasmodium falciparum circumsporozoite protein, aim to stimulate the immune system to recognize and attack the parasite before it can establish an infection. This approach is crucial for malaria patients as it offers a proactive method to prevent infection, potentially reducing the incidence and severity of malaria, and contributing to long-term control and eradication efforts.

Evaluation of 5.1-[NANP]19, a recombinant Plasmodium falciparum vaccine candidate, in adults.Molecular Assessment of Domain I of Apical Membrane Antigen I Gene in Plasmodium falciparum: Implications in Plasmodium Invasion, Taxonomy, Vaccine Development, and Drug Discovery.Transdermal immunization of P. falciparum surface antigen (MSP-119) via elastic liposomes confers robust immunogenicity.

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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

70 Previous Clinical Trials

110,228 Total Patients Enrolled

1 Trials studying Malaria

138 Patients Enrolled for Malaria

BioNTech Responsible PersonStudy DirectorBioNTech SE

36 Previous Clinical Trials

9,869 Total Patients Enrolled

1 Trials studying Malaria

138 Patients Enrolled for Malaria

Media Library

BNT165b1 (RNA-based Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05581641 — Phase 1

Malaria Research Study Groups: BNT165b1, Placebo

Malaria Clinical Trial 2023: BNT165b1 Highlights & Side Effects. Trial Name: NCT05581641 — Phase 1

BNT165b1 (RNA-based Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581641 — Phase 1

~22 spots leftby Sep 2025

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