A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

505

Participants

Timeline

Start Date

March 7, 2022

Primary Completion Date

June 12, 2025

Study Completion Date

June 12, 2025

Conditions
Herpes Simplex
Interventions
BIOLOGICAL

Non-adjuvanted HSV formulation 1

Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

Non-adjuvanted HSV formulation 2

Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

Non-adjuvanted HSV formulation 3

Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 1 with adjuvant 1

Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 2 with adjuvant 1

Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 3 with adjuvant 1

Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 1 with adjuvant 2

Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 2 with adjuvant 2

Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

BIOLOGICAL

HSV formulation 3 with adjuvant 2

Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.

DRUG

Placebo

Two doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study.

BIOLOGICAL

HSVTI_F1

Two doses of the formulation of the HSVTI\_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.

BIOLOGICAL

HSVTI_F2

Two doses of the formulation of the HSVTI\_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.

Trial Locations (30)

1000

GSK Investigational Site, Brussels

2000

GSK Investigational Site, Antwerp

2010

GSK Investigational Site, Darlinghurst

GSK Investigational Site, Sydney

2650

GSK Investigational Site, Edegem

9000

GSK Investigational Site, Ghent

10117

GSK Investigational Site, Berlin

10439

GSK Investigational Site, Berlin

14609

GSK Investigational Site, Rochester

20146

GSK Investigational Site, Hamburg

23219

GSK Investigational Site, Richmond

28010

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Madrid

29600

GSK Investigational Site, Marbella

44787

GSK Investigational Site, Bochum

50106

GSK Investigational Site, Tartu

50674

GSK Investigational Site, Cologne

60596

GSK Investigational Site, Frankfurt

64114

GSK Investigational Site, Kansas City

67207

GSK Investigational Site, Wichita

85015

GSK Investigational Site, Phoenix

98105

GSK Investigational Site, Seattle

H2L 4E9

GSK Investigational Site, Montreal

08001

GSK Investigational Site, Barcelona

08015

GSK Investigational Site, Barcelona

BN2 1ES

GSK Investigational Site, Brighton

L7 8XP

GSK Investigational Site, Liverpool

WC1E 6JB

GSK Investigational Site, London

SO14 0YG

GSK Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT05298254 - A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes | Biotech Hunter | Biotech Hunter