RNA Vaccine for Malaria

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

163 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment BNT165e for malaria?

The research highlights that using RNA-based adjuvants (substances that enhance the body's immune response to an antigen) like 5'ppp-dsRNA with malaria vaccines can induce strong and lasting protection by generating effective antibodies. This suggests that RNA-based approaches, like the BNT165e vaccine, could potentially be effective in treating malaria. ^{1 2 3 4 5}

How is the RNA vaccine BNT165e for malaria different from other treatments?

The RNA vaccine BNT165e for malaria is unique because it uses messenger RNA (mRNA) technology to induce an immune response, which is a novel approach compared to traditional vaccines. This method involves delivering genetic instructions to cells to produce a protein that triggers immunity, potentially offering a more targeted and efficient protection against malaria. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Malaria vaccines since 2000: progress, priorities, products. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Vaccines against malaria-still a long way to go. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Recombinant modified vaccinia virus Ankara-based malaria vaccines. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Why functional pre-erythrocytic and bloodstage malaria vaccines fail: a meta-analysis of fully protective immunizations and novel immunological model. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Immunization with CSP and a RIG-I Agonist is Effective in Inducing a Functional and Protective Humoral Response Against Plasmodium. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Blood-stage malaria vaccines: post-genome strategies for the identification of novel vaccine candidates. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Strategic Variants of CSP Delivered as SynDNA Vaccines Demonstrate Heterogeneity of Immunogenicity and Protection from Plasmodium Infection in a Murine Model. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Messenger RNA expressing PfCSP induces functional, protective immune responses against malaria in mice. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Co-expression of Interleukin-15 Enhances the Protective Immune Responses Induced by Immunization with a Murine Malaria MVA-Based Vaccine Encoding the Circumsporozoite Protein. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Genetically engineered, attenuated whole-cell vaccine approaches for malaria. [2021]