Phase 1
Completed N=60
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
Malaria
Source: ClinicalTrials.gov NCT05581641 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Sep 2025
Primary outcomePrimary: Number of Participants With Solicited Local Reactions — 0; 1; 1; 0 Participants
Summary
This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP).
BNT165b1 was evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local Reactions |
0; 1; 1; 0; 0; 2 | — |
| PRIMARY Number of Participants With Solicited Systemic Reactions |
2; 3; 1; 1; 1; 4 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
4; 7; 4; 3; 1; 4 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAEs) |
2; 3; 2; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures
- Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to follow good practices to reduce their chances of being infected or spreading Coronavirus Disease 2019 [COVID-19]), and other requirements of the trial. This includes that they were able to understand and follow trial-related instructions
- Were aged 18 to 55 years, had a body mass index over 18.5 kg/m^2 and under 35 kg/m^2 and weighed at least 45 kg at Visit 0
- Were healthy, in the clinical judgment of the investigator based on volunteer-reported medical history data, and physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory test outcomes at Visit 0
- Note: Healthy volunteers with pre-existing stable disease (e.g., obesity, hypertension), defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 90 days before Visit 0, were included
- Agreed not to enroll in another trial with an investigational medicinal product (IMP) starting from Visit 0 and until 12 weeks after receiving Dose 3
- Agreed not to travel to a malaria endemic region starting from Visit 0 and until 28 days after Dose 3, as defined per CDC (Centers for Disease Control and Prevention)
- Negative human immunodeficiency virus (HIV) -1 and -2 blood test result at Visit 0
- Negative severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) antigen test result at Visit 0
- Negative hepatitis B surface antigen (HBsAg) test result at Visit 0 and negative anti Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction test result if the anti-HCV was positive at Visit 0
- Volunteers of childbearing potential (VOCBP) who had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test result at Visit 0 and negative urine pregnancy test results before each IMP administration. Volunteers born female who were postmenopausal or permanently sterilized were not considered VOBCP
- VOCBP who agreed to practice a highly effective form of contraception and required their male sexual partners to use condoms with a spermicidal agent, starting at Visit 0 and continuously until 90 days after receiving Dose 3
- VOCBP who agreed not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit 0 and continuously until 90 days after receiving Dose 3
- Men who were sexually active with partners of childbearing potential and who did not have a vasectomy that agreed to use condoms with a spermicidal agent and to practice a highly effective form of contraception with their sexual partners born female during the trial, starting at Visit 0 and continuously until 90 days after receiving Dose 3
- Men who were willing to refrain from sperm donation, starting at Visit 0 and continuously until 90 days after receiving Dose 3
Exclusion Criteria
- History of malaria infection (any species) based on volunteer-reported medical history
- Travel to a malaria endemic region starting 6 months before Visit 0 and continuously until 28 days after receiving Dose 3, as defined per CDC
- Prior residence for greater than or equal to (>=) 6 months in a malaria endemic region
- Were breastfeeding or had intended to become pregnant starting with Visit 0 and continuously until 90 days after receiving Dose 3 or fathered children starting with Visit 0 and continuously until 90 days after receiving Dose 3
- History of any serious adverse reactions to vaccines or to vaccine components such as lipids and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child).
- Current or his
Data sourced from ClinicalTrials.gov (NCT05581641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.