A Clinical Trial in Healthy Volunteers and Volunteers with Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination with an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
- Conditions
- Genital Herpes Simplex Type 2
- Interventions
- Other: Placebo
- Registration Number
- NCT05432583
- Lead Sponsor
- BioNTech SE
- Brief Summary
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2 genital herpes.
Part A will focus on the safety evaluations, and in addition, 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 two dose levels of BNT163 selected based on Part A data and will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163.
Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in subjects with a history of HSV-2 recurrent genital herpes.
- Detailed Description
In Part A, participants will be randomized 5:1 to BNT163:placebo. In Part B, participants will be randomized 1:1 to either of the two selected dose levels based on data from Part A. In Part C, participants will be randomized 1:1 to BNT163:placebo.
In Part A \& B, participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only).
In Part C, participants will receive three intramuscular doses of one fixed dose level of the BNT163 vaccine or placebo. In this part, suppressive antiviral therapy is given over the entire vaccine dosing period (during and between vaccine doses) to prevent administration of the vaccine concomitantly to viral replication and active genital herpes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 308
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A - BNT163 BNT163 Escalating dose levels Part A - Placebo Placebo Isotonic NaCl solution (0.9%) Part B - BNT163 Dose 1 BNT163 - Part B - BNT163 Dose 2 BNT163 - Part C - BNT163 BNT163 One fix dose level of BNT163 Part C - Placebo Placebo Isotonic NaCl solution (0.9%)
- Primary Outcome Measures
Name Time Method Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose Up to 7 days after each dose For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group
Percentage 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 (Parts A & B) or post-Dose 2 (Part C) From Day 1 up to Day 337 For each DL per BNT163 dosing schedule and for the combined placebo group
Percentage of unsolicited AEs occurring up to 28 days after each dose From Day 1 up to Day 197 For each DL per BNT163 dosing schedule and for the combined placebo group
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose Up to 7 days after each dose For each DL per BNT163 dosing schedule and for the combined placebo group
Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose From Day 1 up to Day 197 For each DL per BNT163 dosing schedule and for the combined placebo group
Number of unsolicited AEs occurring up to 28 days after each dose From Day 1 up to Day 197 For each DL per BNT163 dosing schedule and for the combined placebo group
- Secondary Outcome Measures
Name Time Method Geometric mean titer (GMT) at each time point From Day 1 up to Day 337 HSV-2 glycoproteins (g)C2, gD2, and gE2 binding antibody titers enzyme-linked immunosorbent assay (ELISA). HSV-2 neutralizing antibody titers.
For each DL per BNT163 dosing schedule at baseline, 7 days (Parts A \& B only) and 28 days after each dose and at 24 weeks post-Dose 3 (all parts) and for the combined placebo group.Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination From Day 1 up to Day 337 HSV-2 gC2, gD2, and gE2 binding antibody titers enzyme-linked immunosorbent assay (ELISA). HSV-2 neutralizing antibody titers.
For each DL per BNT163 dosing schedule at baseline, 7 days (Parts A \& B only) and 28 days after each dose and at 24 weeks post-Dose 3 (all parts) and for the combined placebo group.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 From Day 1 up to Day 337 For each DL per BNT163 dosing schedule
Trial Locations
- Locations (6)
Alliance for Multispecialty Research, LLC
🇺🇸Tempe, Arizona, United States
Great Lakes Clinical Trials - Flourish Research
🇺🇸Chicago, Illinois, United States
Accellacare Raleigh Medical Group
🇺🇸Raleigh, North Carolina, United States
Accellacare PMG Research Wilmington LLC
🇺🇸Wilmington, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States