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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
Awards & highlights

Study Summary

This trial tests a potential vaccine for malaria that is made of 3 RNAs to see if it's safe, effective and tolerated.

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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
107,572 Total Patients Enrolled
1 Trials studying Malaria
60 Patients Enrolled for Malaria
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,658 Total Patients Enrolled
1 Trials studying Malaria
60 Patients Enrolled for Malaria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept participants aged eighteen or older?

"This clinical trial is limited to participants between the age of 18 and 55. However, there are 64 different trials for those under 18 years old and 36 separate studies open for individuals over 65 respectively."

Answered by AI

Is the recruitment phase for this experiment still ongoing?

"Affirmative. The particulars found on clinicaltrials.gov demonstrate that this medical experiment, which was initially published on November 13th 2023, is actively recruiting participants at the present time. Approximately 108 patients have to be enrolled from 3 different healthcare centres."

Answered by AI

What is the enrollment figure for this trial?

"That is right. According to clinicaltrials.gov, this medical trial initiated on November 13th 2023 and most recently updated a week later on November 21st continues to enroll patients. One hundred and eight volunteers need to be recruited from 3 separate centres of care."

Answered by AI

May I participate in this experiment if my qualifications meet the criteria?

"This clinical trial seeks 108 individuals with malaria aged 18 to 55. Notably, the participants must meet a stringent set of criteria including: being in good general health status, having a body mass index between 18.5 and 35 kg/m^2, providing informed consent, not travelling to any malaria-endemic regions for 6 months prior or 28 days after receiving treatment (depending on which arm they are assigned), negative HIV1 & 2 test results at Visit 0 as well as Hepatitis b surface antigen and anti-HCV antibodies tests if applicable. Women of childbearing potential will also need to provide negative urine pregnancy tests before each IMP"

Answered by AI

Who else is applying?

What site did they apply to?
AMR Knoxville
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
2023. "A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06069544.
All > Paid Studies Las Vegas > Knoxville
~84 spots leftby Jun 2025
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