RNA Vaccine for Malaria

Not currently recruiting at 4 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Diabetes, Cardiovascular diseases, Respiratory diseases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks for Cohorts 1-9, 8 weeks for Cohort 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new RNA-based vaccine, BNT165e, to determine if it can safely prevent malaria, caused by the parasite P. falciparum. The vaccine, composed of three different RNA components, aims to stimulate the body's immune response to combat the malaria parasite. The trial seeks healthy adults who have never had malaria and have not lived in areas where malaria is common. Participants will receive either the vaccine at varying doses or a placebo (inactive substance) for comparison. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain corticosteroids, you may need to stop or adjust them. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the RNA-based malaria vaccine, BNT165e, is undergoing testing to determine its safety and tolerability. This vaccine consists of three RNA components targeting the malaria parasite, Plasmodium falciparum. Although early testing primarily focuses on safety, the FDA temporarily paused the trial due to unspecified concerns. This pause indicates that researchers are investigating safety questions further.

In these early stages, the trial's main goal is to ensure the vaccine's safety for participants. The pause reflects the researchers' careful approach to addressing any potential issues. While this might seem concerning, it is a crucial step to confirm the vaccine's safety before wider use. Prospective participants should stay informed about updates and discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BNT165e because it represents a new approach to malaria prevention using RNA technology. Unlike traditional malaria vaccines that often rely on weakened or inactivated parasites, BNT165e uses messenger RNA to instruct cells to produce proteins that trigger an immune response against the malaria parasite. This innovative mechanism could potentially lead to a more robust and long-lasting protection against malaria. Additionally, RNA vaccines can be rapidly developed and updated, which is a significant advantage in responding to evolving malaria strains.

What evidence suggests that this RNA vaccine might be an effective treatment for malaria?

Research has shown that RNA-based vaccines, such as BNT165e, might be effective against malaria. In this trial, participants will receive either the BNT165e vaccine or a placebo. The BNT165e vaccine targets several parts of the malaria parasite, P. falciparum, which causes the most severe malaria cases. Early results suggest that the vaccine triggers an immune response by producing proteins from both the parasite's infectious stage and its liver stage. This response might prevent the infection from worsening. Although further research is needed to confirm its efficacy, this method has shown promise in building immunity against malaria in early studies. ^{1 2 3 6 7}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Those who are of childbearing potential and have a negative pregnancy test result at Visit 0, as well as any subsequent IMP administrations, will be considered eligible for the study

I can follow the trial's schedule and instructions.

You are deemed to be in good health, as determined by the investigator from your reported medical history, physical examination, 12-lead ECG results, vital signs and laboratory test outcomes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 3-dose regimen of the investigational RNA-based vaccine BNT165e, with doses administered approximately 8 weeks apart for Cohorts 1-9 and 28 days apart for Cohort 10

18 weeks for Cohorts 1-9, 8 weeks for Cohort 10

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and antibody levels

24 weeks after last received IMP dose

Long-term follow-up

Participants are monitored for long-term safety and immunogenicity, including antibody levels up to 365 days after last received IMP dose

Up to 365 days after last received IMP dose

What Are the Treatments Tested in This Trial?

Interventions

• BNT165e

Trial Overview 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).

How Is the Trial Designed?

Group I: BNT165e Experimental Treatment 1 Intervention

Escalating dose levels

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Citations

1. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT165-02

A Clinical Trial to Evaluate the Safety, Efficacy and Immune ... This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06069544

Study Details | NCT06069544 | A Clinical Trial to Evaluate ... An amendment will be submitted to the Health Authorities detailing Part B, which will explore the efficacy of BNT165e in a controlled human malaria infection ...

3. mesamalaria.org mesamalaria.org/mesa-track/safety-tolerability-immunogenicity-and-efficacy-of-rna-based-malaria-vaccine-in-healthy-malaria-naive-adults/

Safety, tolerability, immunogenicity, and efficacy of RNA ... The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of an investigational RNA-based vaccine (BNT165e)

4. withpower.com withpower.com/trial/phase-2-malaria-9-2023-4967f

RNA Vaccine for Malaria · Info for Participants This suggests that RNA-based approaches, like the BNT165e vaccine, could potentially be effective in treating malaria. Show more ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-puts-clinical-hold-on-biontechs-malaria-vaccine-trial/

FDA puts clinical hold on BioNTech's malaria vaccine trial The US FDA has ordered BioNTech to immediately halt its Phase I/II trial of BNT165e, a malaria vaccine candidate, pending changes.

6. investors.biontech.de investors.biontech.de/news-releases/news-release-details/biontech-initiates-phase-1-clinical-trial-malaria-vaccine

BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine ... This first clinical trial (NCT05581641) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1.

7. contagionlive.com contagionlive.com/view/fda-pauses-biontech-s-malaria-vaccine-trial-amid-broader-vaccine-challenges

FDA Pauses BioNTech's Malaria Vaccine Trial Amid ... The FDA has paused BioNTech's phase 1/2a trial of its experimental malaria vaccine, BNT165e, due to unspecified concerns.