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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
Must not have
Current or history of uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program Expert Panel report
History of thyroidectomy, or thyroid disease requiring medication during the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to day 337

Summary

This trial is testing a new vaccine called BNT163. It targets people who already have some immunity to herpes viruses. The vaccine helps the body create antibodies to fight these viruses.

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.
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.
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
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I am between 18 and 55 years old, my BMI is between 18.5 and 35, and I weigh at least 50 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe or uncontrolled respiratory issues like severe asthma.
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I have had thyroid surgery or needed thyroid medication in the past year.
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I have a diagnosed bleeding disorder that needs special care.
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I have a history of significant heart problems.
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I haven't received blood products or immunoglobulin in the last 120 days.
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I have or had an eye infection or brain disease caused by herpes.
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My blood pressure is usually under 140/90 mm Hg, with rare brief increases.
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I have a condition that affects my immune system, such as an autoimmune disease or a history of organ transplant.
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I haven't had cancer, except for skin cancer, in the last 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
Part A and B only - 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

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C - BNT163Experimental Treatment1 Intervention
One fix dose level of BNT163
Group II: Part B - BNT163 Dose 2Experimental Treatment1 Intervention
Group III: Part B - BNT163 Dose 1Experimental Treatment1 Intervention
Group IV: Part A - BNT163Experimental Treatment1 Intervention
Escalating dose levels
Group V: Part A - PlaceboPlacebo Group1 Intervention
Isotonic NaCl solution (0.9%)
Group VI: Part C - PlaceboPlacebo Group1 Intervention
Isotonic NaCl solution (0.9%)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Genital Herpes are antiviral medications such as acyclovir, valacyclovir, and famciclovir. These drugs work by inhibiting the replication of the herpes simplex virus (HSV), thereby reducing the severity and duration of outbreaks. The investigational vaccine BNT163 aims to induce immune responses specifically against HSV-1 and HSV-2 by generating neutralizing antibodies. This approach is significant for Genital Herpes patients as it could potentially provide long-term immunity and reduce the frequency of outbreaks, offering a more sustainable and preventive solution compared to current antiviral therapies.
A large-scale, placebo-controlled, dose-ranging trial of peroral valaciclovir for episodic treatment of recurrent herpes genitalis. Valaciclovir HSV Study Group.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BioNTech SELead Sponsor
71 Previous Clinical Trials
110,871 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,700 Total Patients Enrolled

Media Library

Genital Herpes Research Study Groups: Part B - BNT163 Dose 1, Part B - BNT163 Dose 2, Part A - BNT163, Part A - Placebo, Part C - BNT163, Part C - Placebo
~126 spots leftby Apr 2026
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