Healthy Volunteer Study for Herpes Vaccine (BNT163-01)
Draft
18-55 years
All
Phase
1
20 participants needed
1 Location
Brief description of study
Dr. Tebas in the Division of Infectious Disease
at the University of Pennsylvania is looking for volunteers ages 18-55 with a
history of recurrent HSV-2 genital herpes to participate in a study
evaluating an investigational mRNA-based vaccine for the prevention of genital
lesions.
The study consists of 11 study visits to the
Perelman Center for Advanced Medicine, during which time the study staff will
collect vitals, blood samples, swabs, and provide 2 doses of the investigational mRNA vaccine.
Volunteers will be paid each visit for their time and travel.
Detailed description of study
If you agree to join the study, you will be asked to complete the following research procedures:
- Receive 2 doses of a study vaccine (BNT163) and complete an injection diary
- Have your medical information reviewed
- Undergo examinations including, but not limited to, an electrocardiogram (ECG), physical exam, urine test, genital swabs
- Blood tests to determine if you are healthy
- Undergo genetic testing
- Have blood collected for the duration of the study
The study consists of 11 visits over approximately 67 weeks (1.2 years), but additional visits may be needed for additional safety.
Please note that this study requires in-person clinical visits at the University of Pennsylvania Perelman Center for Advanced Medicine, located in Philadelphia.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy,Volunteer,Herpes
-
Age: Between 18 Years - 55 Years
-
Gender: All
To participate in this trial, you must meet the following criteria:
- Have a body mass index (BMI) over 18.5 kg/m2 and under 35 kg/m2 and weigh at least 50 kg at initial visit.
- Be willing and able to comply with scheduled visits, treatment schedule and laboratory tests
- Be overall healthy in the investigator's clinical judgment based on medical history, physical examination, 12-lead ECG, vital signs, and screening laboratory tests (blood clinical laboratory) at initial visit.
- Have had a diagnosis of recurrent genital lesions caused by herpes confirmed in medical records in the past.
- Be willing to stop suppressive therapy during the entirety study. Episodic therapy is allowed for most of the study.
- Cannot be pregnant or infant feeding.
If you are interested in participating in this research study and want to know more about safety risks, please fill out our online interest form below, or call our offices at (215) - 349-8092. We will be happy to answer any questions.
Updated on
05 Aug 2024.
Study ID: 852362
