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Virus Therapy

Genital Herpes Vaccine for Genital Herpes

Phase 1
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 to 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to day 337
Awards & highlights

Study Summary

This trialwill assess safety & the impact of pre-existing immunity on the safety & effectiveness of a vaccine dose. It has two parts: A for safety & B for expanded safety & dose-response.

Who is the study for?
Healthy adults aged 18-55, with a BMI between 18.5 and 35 kg/m^2, who are not pregnant or planning to become so during the trial. Participants must test negative for HIV, Hepatitis B & C, syphilis, and drugs of abuse. They should agree to contraception use and not have any history of severe reactions to vaccines or certain medical conditions.Check my eligibility
What is being tested?
The trial is testing an investigational vaccine called BNT163 against genital herpes by comparing it with a placebo. It has two parts: Part A assesses safety and dose-response related to immune responses; Part B further evaluates safety based on pre-existing immunity to Herpes Simplex Virus.See study design
What are the potential side effects?
While specific side effects are not listed here, common vaccine-related side effects can include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old, my BMI is between 18.5 and 35, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to day 337
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 337 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
Number of unsolicited AEs occurring up to 28 days after each dose
+3 more
Secondary outcome measures
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
Percentage 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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part B - BNT163 Dose 2Experimental Treatment1 Intervention
Group II: Part B - BNT163 Dose 1Experimental Treatment1 Intervention
Group III: Part A - PlaceboExperimental Treatment1 Intervention
Isotonic NaCl solution (0.9%)
Group IV: Part A - BNT163Experimental Treatment1 Intervention
Escalating dose levels

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
64 Previous Clinical Trials
107,450 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,536 Total Patients Enrolled

Media Library

Genital Herpes Research Study Groups: Part A - Placebo, Part B - BNT163 Dose 1, Part B - BNT163 Dose 2, Part A - BNT163

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrolment in this research project over eighty?

"The requirements for enrollment stipulate that potential participants must have a minimum age of 18 and should not exceed 54 years."

Answered by AI

Has BNT163 received clearance from the FDA?

"The safety of BNT163 was given a score of 1, as it is in the preliminary stages and has only limited evidence validating its efficacy and security."

Answered by AI

Is enrollment for the trial open to additional participants?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which was initially posted on December 8th 2022, is still looking for participants. In total 108 patients need to be recruited from two different medical sites."

Answered by AI

How many participants are being recruited for this research project?

"That is correct. According to the details on clinicaltrials.gov, this research study has been recruiting since December 8th 2022 and began seeking 108 participants from 2 distinct sites."

Answered by AI

Is it possible to volunteer for this research experiment?

"This clinical trial is looking for 108 people aged between 18 and 54 who have genital herpes simplex type 2. Candidates must be willing to abide by the scheduled visits, treatment plan, laboratory tests, lifestyle restrictions (e.g., social distancing to reduce chances of infection), and other requirements outlined in the study protocol. Furthermore, they should be generally healthy according to medical history assessments at Visit 0; additionally, negative HIV-1/2 blood test results are required along with anti-Hepatitis c virus antibodies or undetectable HCV viral load if tested positive for anti-HCV at Visit 0. Syphilis testing"

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
North Carolina
Other
What site did they apply to?
Other
Hospital of the University of Pennsylvania
Accellacare PMG Research Wilmington LLC
Accellacare Raleigh Medical Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0

What questions have other patients asked about this trial?

What are the side effects? How long do screening visits take? How much is the pay for this trial study?
PatientReceived 2+ prior treatments
How often do we need to appear in person?
PatientReceived no prior treatments

Why did patients apply to this trial?

Finding a cute. Para fazer Parte dos testes com a vacina. Hsv1 genital herpes candidate fighting for a cure.
PatientReceived 1 prior treatment
I am hoping this drug will help reduce the stigma! Just want to speed up the process of not having hsv1/2.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Accellacare Raleigh Medical Group: < 24 hours
  2. Hospital of the University of Pennsylvania: < 24 hours
  3. Accellacare PMG Research Wilmington LLC: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
2022. "A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432583.
All > Genital Herpes
~135 spots leftby Dec 2025
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