Genital Herpes Vaccine for Genital Herpes

Recruiting at 5 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: BioNTech SE

Must be taking: Antiviral suppression therapy

Must not be taking: Chronic suppressive antivirals

Disqualifiers: Diabetes, Hypertension, Cardiovascular diseases, others

Compensation: Varies

Number of Visits: Unknown

308 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are on chronic suppressive antiviral therapy for HSV-1 or HSV-2, you may need to stop it for Part A and B of the trial.

What data supports the effectiveness of the treatment BNT163 for genital herpes?

While there is no direct data on BNT163, research on similar vaccines shows promise. For example, a vaccine using a different approach was 73 to 74 percent effective in preventing genital herpes in women who had never been infected before. ^{1 2 3 4 5}

Is the BNT163 vaccine safe for humans?

The BNT162b2 vaccine, which is similar to BNT163, has been generally safe in humans, with most side effects being mild to moderate, like pain or fatigue. However, rare cases of more serious side effects, such as Bell's palsy and herpes zoster, have been reported. ^{6 7 8 9 10}

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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.

Inclusion Criteria

Negative human immunodeficiency virus (HIV)-1 and HIV-2 blood test at Visit 0

Overall healthy in the clinical judgment of the investigator based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and screening laboratory tests (blood clinical laboratory) at Visit 0

I am not pregnant, postmenopausal, or permanently sterilized.

Exclusion Criteria

I haven't had seizures or taken seizure medications in the last 3 years.

History of psychiatric illness, including alcohol abuse or drug addiction within 1 year before Visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol specified assessments

I have or had genital herpes, but not oral herpes or herpetic whitlow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Participants receive escalating doses of BNT163 or placebo to evaluate safety and immune response

Approximately 24 weeks

Multiple visits for each dose administration and follow-up

Expanded Safety and Dose Evaluation (Part B)

Participants receive selected dose levels of BNT163 to further assess safety and immune response

Approximately 24 weeks

Multiple visits for each dose administration and follow-up

Safety and Immunogenicity Evaluation (Part C)

Participants with recurrent HSV-2 receive BNT163 or placebo to evaluate safety and immune response

Approximately 24 weeks

Multiple visits for each dose administration and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks post-final dose

Treatment Details

Interventions

• BNT163
• Placebo

Trial Overview 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.

Participant Groups

Group I: Part C - BNT163 Experimental Treatment 1 Intervention

One fix dose level of BNT163

Group II: Part B - BNT163 Dose 2 Experimental Treatment 1 Intervention

Group III: Part B - BNT163 Dose 1 Experimental Treatment 1 Intervention

Group IV: Part A - BNT163 Experimental Treatment 1 Intervention

Escalating dose levels

Group V: Part A - Placebo Placebo Group 1 Intervention

Isotonic NaCl solution (0.9%)

Group VI: Part C - Placebo Placebo Group 1 Intervention

Isotonic NaCl solution (0.9%)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Findings from Research

GEN-003, a therapeutic vaccine for genital herpes simplex virus type 2 (HSV-2), showed significant reductions in viral shedding and lesion rates, particularly with the 60 µg antigen combined with 50 or 75 µg adjuvant, demonstrating durable effects for up to 12 months.

No serious adverse events were reported, indicating that GEN-003 is a safe option for individuals with symptomatic HSV-2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial. Van Wagoner, N., Fife, K., Leone, PA., et al.[2020]

The HSV-1 glycoprotein B (gB1) vaccine delivered via a feline immunodeficiency virus (FIV) vector showed promising results, protecting 100% of mice from severe HSV-1 disease and 75% from severe HSV-2 disease in a study involving C57BL/6 mice.

Vaccination significantly reduced mortality, preventing death in 83% of mice exposed to a lethal dose of HSV-2, while all naive and mock-vaccinated controls died, indicating the vaccine's potential efficacy against genital herpes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lentiviral vector-based, herpes simplex virus 1 (HSV-1) glycoprotein B vaccine affords cross-protection against HSV-1 and HSV-2 genital infections. Chiuppesi, F., Vannucci, L., De Luca, A., et al.[2021]

The most effective prophylactic genital herpes vaccine developed so far is a recombinant subunit vaccine (truncated HSV-2 gD with alum/MPL), which shows 73-74% efficacy in preventing genital disease in herpes simplex virus seronegative women.

While the vaccine is promising for reducing genital herpes and potentially lowering rates of perinatal and oral-facial diseases, its effectiveness will ultimately depend on acceptance by healthcare professionals and the public, highlighting the need for further research and outreach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatrics and herpes simplex virus vaccines. Rupp, R., Rosenthal, SL., Stanberry, LR.[2008]

A herpes vaccine that provides partial protection (40% efficacy) can significantly impact the epidemiology of genital herpes, especially if it reduces asymptomatic viral shedding, rather than just preventing disease symptoms.

The study suggests that even a vaccine that only protects women who have never been infected can lead to increased disease prevalence in men, highlighting the importance of universal vaccination to control herpes transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential epidemiological impact of a genital herpes vaccine for women. Garnett, GP., Dubin, G., Slaoui, M., et al.[2019]

The Ac NFU1 (S-) MRC vaccine was tested in 60 at-risk subjects and showed no serious side effects, indicating a good safety profile for this potential herpes genitalis prevention method.

After 18 months of follow-up, none of the vaccinated participants contracted herpes genitalis, suggesting that the vaccine may be effective in providing long-term protection against the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and immunogenicity of vaccine Ac NFU1 (S-) MRC towards the prevention of herpes genitalis. Skinner, GR., Woodman, CB., Hartley, CE., et al.[2019]

A 39-year-old immunocompetent patient developed VZV meningitis after receiving the BNT162b2 mRNA COVID-19 vaccine, highlighting a potential risk of herpes zoster infection post-vaccination.

The patient was successfully treated with intravenous aciclovir and resolved symptoms within 48 hours, but he declined the second vaccine dose due to concerns about adverse effects, emphasizing the importance of sharing clinical experiences to inform vaccine safety discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoster meningitis in an immunocompetent young patient post first dose of BNT162b2 mRNA COVID-19 vaccine, a case report. Kerr, C., O'Neill, S., Szucs, A., et al.[2022]

In a study of over 394,000 individuals vaccinated with the Pfizer BNT162b2 vaccine, no significant association was found between the vaccine and the occurrence of Bell's palsy, Guillain-Barré syndrome (GBS), or herpes zoster, suggesting a reassuring safety profile.

While symptoms of numbness or tingling were reported more frequently among vaccinated individuals compared to unvaccinated controls, the overall findings support the vaccine's safety, with no alarming increase in serious neurological complaints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. Shasha, D., Bareket, R., Sikron, FH., et al.[2022]

A 32-year-old woman developed Bell's palsy shortly after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, suggesting a possible association, although a causal relationship cannot be definitively established.

The patient experienced full recovery within 15 days, indicating that while Bell's palsy can occur post-vaccination, it may follow a benign course similar to idiopathic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bell's Palsy Secondary to COVID-19 Vaccine Pfizer: Case report]. González-Enríquez, JO.[2023]

In a study involving 80 healthcare workers for the BNT162b2 vaccine and 1440 for the AZD1222 vaccine, adverse events (AEs) were reported by 52.5% after the first dose and 76.2% after the second dose of BNT162b2, while 90.9% reported AEs after the first dose of AZD1222, indicating a higher incidence of AEs with the adenovirus-vectored vaccine.

Most AEs were mild to moderate and transient, with no serious incidents like anaphylaxis or neurological AEs reported, suggesting that while AEs are common, they are generally not severe, which could help alleviate vaccine hesitancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Adverse Events between mRNA and Adenovirus-Vectored COVID-19 Vaccines in Healthcare Workers. Wi, YM., Kim, SH., Peck, KR.[2021]

The BNT162b2 COVID-19 vaccine has a favorable safety profile in adolescents, with over one million participants contributing to the data, showing that most adverse events are mild and include pain at the injection site and fatigue.

Serious adverse events were rare, and while some life-threatening reactions were reported, they occurred infrequently, emphasizing the importance of vaccination in controlling the pandemic and maintaining public confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis. Katoto, PDMC., Brand, AS., Byamungu, LN., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A lentiviral vector-based, herpes simplex virus 1 (HSV-1) glycoprotein B vaccine affords cross-protection against HSV-1 and HSV-2 genital infections. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pediatrics and herpes simplex virus vaccines. [2008]

4. England pubmed.ncbi.nlm.nih.gov

The potential epidemiological impact of a genital herpes vaccine for women. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Preparation and immunogenicity of vaccine Ac NFU1 (S-) MRC towards the prevention of herpes genitalis. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Zoster meningitis in an immunocompetent young patient post first dose of BNT162b2 mRNA COVID-19 vaccine, a case report. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study. [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

[Bell's Palsy Secondary to COVID-19 Vaccine Pfizer: Case report]. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Early Adverse Events between mRNA and Adenovirus-Vectored COVID-19 Vaccines in Healthcare Workers. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12-17 years: A systematic review and meta-analysis. [2022]