BNT163 for Genital Herpes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Genital HerpesBNT163 - Biological
Eligibility
18 - 54
All Sexes
What conditions do you have?
Select

Study Summary

This exploratory trial will have two parts. While Part A will focus on the safety evaluations, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A.

Eligible Conditions
  • Genital Herpes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 3 Secondary · Reporting Duration: From day 1 up to day 337

Day 197
Number of unsolicited AEs from Dose 1 to 28 days after Dose 3
Number of unsolicited AEs from Dose 1 to 28 days post-Dose 3
Proportion of participants with at least one AE occurring up to 60 days post randomization in Part B, then up to 28 days after Dose 3 in Part B
Proportion of participants with at least one TEAE occurring up to 60 days post randomization in Part B, then up to 28 days after Dose 3 in Part B
Day 337
Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination
Geometric mean titer (GMT) at each time point
Proportion of participants in each cohort with at least one serious adverse event, or adverse event of special interest, or medically attended adverse event occurring up to 24 weeks after Dose 3
Proportion of participants in each cohort with at least one serious adverse event, or adverse event of special interest, or medically attended adverse event occurring up to 24 weeks post-Dose 3
Proportion of participants with seroconversion defined as a minimum of 4-fold increase from baseline of neutralizing and binding antibody titers to each subsequent time point after vaccination
Day 60
Proportion of participants with at least one adverse event (AE) occurring up to 60 days post randomization in Part A
Therapeutic procedure
Day 7
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each investigational medicinal product (IMP) dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each IMP dose

Trial Safety

Trial Design

2 Treatment Groups

BNT163
1 of 2
Placebo
1 of 2

Experimental Treatment

108 Total Participants · 2 Treatment Groups

Primary Treatment: BNT163 · Has Placebo Group · Phase 1

BNT163
Biological
Experimental Group · 1 Intervention: BNT163 · Intervention Types: Biological
Placebo
Other
Experimental Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 up to day 337

Who is running the clinical trial?

BioNTech SELead Sponsor
51 Previous Clinical Trials
90,840 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
28 Previous Clinical Trials
7,298 Total Patients Enrolled

Eligibility Criteria

Age 18 - 54 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have negative HIV-1 and HIV-2 blood tests at Visit 0.
You have given informed consent before initiation of any trial-specific procedures.
You are aged 18 to less than 55 years, have a body mass index over 18.5 kg/m^2 and under 35 kg/m^2 and weigh at least 50 kg at Visit 0.
You have negative hepatitis B surface antigen at visit 0.

Who else is applying?

What state do they live in?
North Carolina42.9%
Washington14.3%
Massachusetts14.3%
Other28.6%
What site did they apply to?
Accellacare Raleigh Medical Group100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
025.0%
175.0%
Why did patients apply to this trial?
  • "I am interested in the study for genital herpes. I want to help people."
  • "I come from a very conservative religious family that i am not supposed to have *** before marriage let alone have and std. i am expected to get married in two years (a virgin) to a virgin. I need anything that can help me."
What questions have other patients asked about this trial?
  • "How long do screening visits take?"
  • "How much is the pay for this trial study?"

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Accellacare Raleigh Medical Group: < 24 hours
Average response time
  • < 2 Days