Healthy Volunteer Study for Herpes Vaccine (BNT163-01)

Recruiting

18 years - 55 years

All

Phase 1

35 participants needed

1 Location

Brief description of study

The research study is being conducted to determine the best dose of an investigational vaccine called BNT163, and to determine if the vaccine is safe and well-tolerated. An investigational vaccine is a vaccine that is not approved by the US Food and Drug Administration (FDA), for use outside of this study. The FDA is the health authority that gives approval for new vaccines for use in the United States.

This research study will test different dose levels to determine the dose level that is best tolerated and safe in healthy human participants and then use that dose level to collect more information about the safety and tolerability of BNT163. The vaccine being tested in this study is a vaccine that is being developed for the prevention of genital herpes lesions caused by HSV-2 (herpes simplex 2) and possibly HSV-1 (herpes simplex 1). This study is the first time it will be tested in humans.

Detailed description of study

If you agree to join the study, you will be asked to complete the following research procedures:

Receive a study vaccine (BNT163) and complete an injection diary
Have your medical information reviewed
Undergo examinations including, but not limited to, an ECG, physical exam, urine test,
Blood tests to determine if you are healthy.
Undergo genetic testing
Have blood collected for the duration of the study.

Your participation will last approximately 80 weeks, but additional visits may be needed for additional safety tests.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Healthy,Volunteer
Age: 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 Visit 0
Be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID 19), and other requirements of the trial.
Be overall healthy in the investigator's clinical judgment based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and screening laboratory tests (blood clinical laboratory) at Visit 0.
Cannot be pregnant or infant feeding

Updated on 04 Aug 2024. Study ID: 852362

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