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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 from day 1 up to day 351

Awards & highlights

Study Summary

This trial tests a new vaccine to protect against malaria - it will assess safety, tolerability, & immunogenicity at 3 dose levels.

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.Check my eligibility

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.See study design

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 ~ from day 1 up to day 351

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to day 351

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 351 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 solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose

Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose

Proportion of participants in each cohort with at least one serious adverse event (SAE) occurring up to 24 weeks after Dose 3

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BNT165b1Experimental Treatment1 Intervention

Escalating dose levels

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

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

109,121 Total Patients Enrolled

1 Trials studying Malaria

126 Patients Enrolled for Malaria

BioNTech Responsible PersonStudy DirectorBioNTech SE

33 Previous Clinical Trials

9,696 Total Patients Enrolled

1 Trials studying Malaria

126 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

Frequently Asked Questions

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

What characteristics make individuals suitable participants for this trial?

"In order to be selected for this research, patients must have malaria and a chronological age between 18 and 55. As of now, the study is attempting to enrol 60 participants."

Answered by AI

Are researchers recruiting participants who are 50 or older for this trial?

"This clinical trial will accept patients who are over 18 years of age but under 55."

Answered by AI

Are any new participants being enrolled for this research project?

"The records on clinicaltrials.gov suggest that this trial is presently calling for participants. This experiment was initially advertised on December 15th 2022 and has been revised as recently as January 12 2023."

Answered by AI

Has BNT165b1 passed the necessary regulatory requirements to be accepted by the Food and Drug Administration?

"The safety of BNT165b1 has been marked with a score of 1 on our internal scale, given that this is only in its initial clinical trial phase and the data supporting both efficacy and safety remains relatively scarce."

Answered by AI

How many individuals are participating in the clinical experiment?

"Affirmative. The clinical trial database shows that this study, which was posted on December 15th 2022, is currently looking for volunteers. Around 60 patients are needed from 3 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

2022. "Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05581641.

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