What side effects are associated with this type of intervention?

Common treatments for genital herpes include antiviral medications such as acyclovir, valacyclovir, and famciclovir, which are used to manage symptoms and reduce viral shedding. Side effects of these antiviral treatments are generally mild and may include headache, nausea, and fatigue. For vaccines like BNT163 that aim to induce immune responses against HSV-1 and HSV-2, side effects observed in similar vaccine trials include injection site reactions (pain, redness, swelling), fever, chills, fatigue, and headache. These side effects are typically transient and resolve within a few days.

What prior FDA approvals exist?

The FDA has approved several antiviral medications for the treatment of genital herpes, including acyclovir, valacyclovir, and famciclovir. These drugs help to reduce the severity and frequency of symptoms but do not cure the infection. While there are no FDA-approved vaccines for genital herpes that induce immune responses against HSV-1 and HSV-2, research is ongoing in this area, including the investigational vaccine BNT163, which aims to elicit neutralizing antibodies and potentially provide a more effective preventive measure.

What other types of research exist?

Promising alternatives to BNT163 for genital herpes treatment include: 1) Genocea's GEN-003, a therapeutic vaccine that has shown significant reduction in viral shedding and lesion rates in clinical trials. 2) Vical's HSV-2 therapeutic vaccine, which has demonstrated a reduction in viral shedding in phase 2 trials. 3) Pritelivir, an antiviral drug that inhibits the helicase-primase enzyme complex, showing efficacy in reducing viral shedding and lesion formation in clinical studies. These alternatives offer potential new avenues for managing genital herpes in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to day 337

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%)

0 / 10Eligibility criteria met

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.