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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05432583
Other study ID # BNT163-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 8, 2022
Est. completion date December 2025

Study information

Verified date April 2024
Source BioNTech SE
Contact BioNTech clinical trials patient information
Phone +49 6131 9084
Email patients@biontech.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This exploratory trial will have two parts. Part A is a dose escalation part and Part B is an expanded safety and dose evaluation part. Part A will focus on the safety evaluations, but 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 also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A.


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. Participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only).


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Study Design


Intervention

Biological:
BNT163
Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection
Other:
Placebo
Placebo

Locations

Country Name City State
United States Great Lakes Clinical Trials - Flourish Research Chicago Illinois
United States CTI Clinical Research Center Cincinnati Ohio
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Accellacare Raleigh Medical Group Raleigh North Carolina
United States Alliance for Multispecialty Research, LLC Tempe Arizona
United States Accellacare PMG Research Wilmington LLC Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
BioNTech SE

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group Up to 7 days after each dose
Primary Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose For each DL per BNT163 dosing schedule and for the combined placebo group Up to 7 days after each dose
Primary Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose For each DL per BNT163 dosing schedule and for the combined placebo group From Day 1 up to Day 197
Primary 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 For each DL per BNT163 dosing schedule and for the combined placebo group From Day 1 up to Day 337
Primary Number of unsolicited AEs occurring up to 28 days after each dose For each DL per BNT163 dosing schedule and for the combined placebo group From Day 1 up to Day 197
Primary Percentage of unsolicited AEs occurring up to 28 days after each dose For each DL per BNT163 dosing schedule and for the combined placebo group From Day 1 up to Day 197
Secondary Geometric mean titer (GMT) at each time point 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
From Day 1 up to Day 337
Secondary Geometric mean fold (GMF) change from baseline of neutralizing and binding antibody titers to each time point after vaccination 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
From Day 1 up to Day 337
Secondary 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 For each DL per BNT163 dosing schedule From Day 1 up to Day 337
See also
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Completed NCT01667341 - Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine Phase 1/Phase 2
Completed NCT02300142 - Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study Phase 2
Completed NCT02030301 - Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults Phase 1/Phase 2