MalariaPhase 1NCT05581641
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
A Phase 1 study testing BNT165b1 in people with Malaria, run by BioNTech SE at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- BNT165b1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Dec 2022to 6 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 history of the following medical conditions:
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- Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the US National Asthma Education and Prevention Program Expert Panel report, 2020 - e.g., exclude a volunteer who:
- Used a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Used high dose inhaled corticosteroids (per American Academy of Allergy Asthma \& Immunology), or
- In the past year has had either of the following:
- Greater than one exacerbation of symptoms treated with oral/parenteral corticosteroids;
- Needed hospitalization, or intubation for asthma.
- Diabetes mellitus type 1 or type 2, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes).
- Hypertension:
- If a person had been found to have elevated blood pressure or hypertension during screening or previously, they were excluded for blood pressure that is not well controlled. Well controlled blood pressure was defined as consistently less than or equal to (<=)140 mm Hg systolic and <= 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be <= 150 mm Hg systolic and <=100 mm Hg diastolic at enrollment.
- If a person did not have a history of elevated blood pressure or hypertension previously or during screening, also excluded for systolic blood pressure greater than (>)150 mm Hg at enrollment or diastolic blood pressure ≥100 mm Hg at enrollment.
- Malignancy within 5 years of screening, excluding localized basal or squamous cell cancer;
- Any current or history of cardiovascular diseases, (e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias), unless such disease was not considered relevant for participation in this trial in the investigator's judgment;
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions);
- Seizure disorder: History of seizure(s) within past 3 years. Also excluded if volunteer had used medications in order to prevent or treat seizure(s) at any time within the past 3 years
- Documented major psychiatric illness, including bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that at the discretion of the investigator could interfere with participation and follow-up as outlined by the trial
- The following diseases associated with immune dysregulation:
- Primary immunodeficiencies.
- History of solid organ or bone marrow transplantation.
- Asplenia: any condition resulting in the absence of a functional spleen.
- Currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, psoriasis, etc.
- Previous vaccination with an approved or investigational malaria vaccine at any time or having taken part in a human malaria challenge study
- Receipt of any investigational product within 28 days before Visit 0
- Any planned non-trial vaccinations starting at Visit 0 and continuously until Visit 11 (28 days after Dose 3)
- Note: Seasonal influenza and COVID-19 vaccines were allowed; however, they should have been administered at least 14 days before or after any IMP injection
- Received blood/plasma products or immunoglobulin within 120 days before Visit 1 or planned administration starting at Visit 0 and continuously until Visit 12
- Received allergy treatment with antigen injections within 28 days before first IMP administration or that were scheduled within 14 days after Visits 1, 5 and 9
- Current or planned treatment with immunosuppressive therapy, including systemic corticosteroids (if systemic corticosteroids are administered for >=14 days at a dose of >= 20 mg/day of prednisone or equivalent) starting at Visit 0 and continuously until Visit 11 (28 days after Dose 3). Intraarticular, intrabursal, or topical (skin or eyes) corticosteroids were permitted
- Had a history of alcohol abuse or drug addiction within 1 year before Visit 0 or had a history (within the past 5 years) of substance abuse which in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments
- Any existing condition which may have affected vaccine injection and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc.
- Were vulnerable individuals as per International Council for Harmonization (ICH) E6 definition, i.e., were individuals whose willingness to volunteer in a clinical trial may have been unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate
- Any screening hematology and/or blood chemistry laboratory value that met the definition of a Grade >= 2 abnormality or of Grade 1 at the investigator's discretion at Visit 0. Individuals with abnormal but not clinically significant parameters were not included in the toxicity guidance may have been considered eligible at the discretion of the investigator
- Had current febrile illness (body temperature >=38.0°C/ >=100.4°F) or febrile illness within 48 hours of Visit 0
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland, Center for Vaccine Development
Baltimore, Maryland, 21201
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
About this study
Official title: An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against Malaria
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.
Read the detailed description
The trial had enrolled participants into three cohorts by dose level who were randomized 4:1 to BNT165b1: placebo. The trial used a staggered dose escalation schema with sentinel participants for Dose 1 in all cohorts.
- Conditions
- Malaria
- Being tested
- BNT165b1, Placebo
- Keywords
- RNA vaccine, Vaccine, Active immunization against malaria, Plasmodium falciparum
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT165b1Biological
RNA vaccine for active immunization against malaria administered as intramuscular injection.
PlaceboOther
Placebo matched to RNA vaccine administered as intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BNT165b1: 3 Micrograms (mcg) | Experimental | Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. Receives: Biological: BNT165b1 |
| Cohort 2: BNT165b1: 10 mcg | Experimental | Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. Receives: Biological: BNT165b1 |
| Cohort 3: BNT165b1: 30 mcg | Experimental | Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. Receives: Biological: BNT165b1 |
| Placebo | Placebo comparator | Participants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Measured: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
Number of Participants With Solicited Systemic Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Measured: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Measured: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85] and Dose 3 [at Day 211])
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Measured: From Day 1 up to 24 weeks after Dose 3 (i.e., up to Day 351)
Number of Participants With Medically Attended Adverse Events (MAAEs)
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Measured: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85], Dose 3 [at Day 211])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start15 Dec 2022
- Primary completion23 Feb 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581641
- Sponsor's protocol ID
- BNT165-01
- Status last verified
- Aug 2025
- First submitted
- 12 Oct 2022
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mo AX, McGugan G, Pesce JT. Meeting report: Expert consultation on late arresting replication competent (LARC) malaria sporozoite vaccine research & development. Vaccine. 2025 Apr 30;54:127009. doi: 10.1016/j.vaccine.2025.127009. Epub 2025 Apr 16.
PubMed 40245769
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against Malaria
- ClinicalTrials.gov ID
- NCT05581641
- Acronym / sponsor ID
- BNT165-01
- Conditions
- Malaria
- Keywords
- RNA vaccine, Vaccine, Active immunization against malaria, Plasmodium falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial had enrolled participants into three cohorts by dose level who were randomized 4:1 to BNT165b1: placebo. The trial used a staggered dose escalation schema with sentinel participants for Dose 1 in all cohorts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BNT165b1: 3 Micrograms (mcg) | Experimental | Biological: BNT165b1Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 2: BNT165b1: 10 mcg | Experimental | Biological: BNT165b1Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Cohort 3: BNT165b1: 30 mcg | Experimental | Biological: BNT165b1Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (38 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT165b1RNA vaccine for active immunization against malaria administered as intramuscular injection. | Biological | Cohort 1: BNT165b1: 3 Micrograms (mcg), Cohort 2: BNT165b1: 10 mcg, Cohort 3: BNT165b1: 30 mcg |
| PlaceboPlacebo matched to RNA vaccine administered as intramuscular injection. | Other | Placebo |
Primary outcome
Number of Participants With Solicited Local Reactions
Time frame: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Number of Participants With Solicited Systemic Reactions
Time frame: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Number of Participants With Adverse Events (AEs)
Time frame: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85] and Dose 3 [at Day 211])
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From Day 1 up to 24 weeks after Dose 3 (i.e., up to Day 351)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Number of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85], Dose 3 [at Day 211])
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40245769Mo AX, McGugan G, Pesce JT. Meeting report: Expert consultation on late arresting replication competent (LARC) malaria sporozoite vaccine research & development. Vaccine. 2025 Apr 30;54:127009. doi: 10.1016/j.vaccine.2025.127009. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BioNTech Responsible Person study director
BioNTech SE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BNT165b1 in people with Malaria, run by BioNTech SE at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Local Reactions (time frame: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.