A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an … (NCT06069544) | Clinical Trial Compass
CompletedPhase 1/2
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
United States163 participantsStarted 2023-11-13
Plain-language summary
This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.
The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles. The BNT165c RNA encodes the full Plasmodium falciparum circumsporozoite protein. The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
✕. 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:
✕. History of Diabetes mellitus type 1 or type 2, including cases controlled with diet alone or elevated hemoglobin A1C ≥6.5% at screening (not excluded: history of isolated gestational diabetes).
✕. Hypertension:
✕. Malignancy within 5 years of screening, excluding localized basal or squamous cell skin 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 is not considered relevant for participation in this trial in the investigator's judgment.
✕. An abnormal screening ECG (i.e., showing the corrected QT interval by Fridericia \[QTcF\] greater than 450 ms; significant ST-T wave changes suggestive of myocardial ischemia or of an acute or indeterminate-age myocardial infarction; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions; complete right or left bundle branch block \[QRS greater than 120 ms\]; second-or third-degree atrioventricular block); or other clinically significant abnormalities on the ECG at the investigator's discretion.
What they're measuring
1
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
Timeframe: Up to 7 days after each dose
2
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle/joint pain, and fever) recorded up to 7 d after each dose
Timeframe: Up to 7 days after each dose
3
Frequency of participants with at least one adverse event occurring until 28 days after each dose
Timeframe: Up to 28 days after each dose
4
Frequency of participants with at least one medically attended adverse event occurring until 24 weeks after last received IMP dose
Timeframe: Up to 24 weeks after last received IMP dose
5
Frequency of participants in each cohort with at least one serious adverse event occurring until 24 weeks after last received IMP dose
Timeframe: Up to 24 weeks after last received IMP dose
✕. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
✕. Seizure disorder: History of seizure(s) within the past 3 years or has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.