search
Back to results

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2 (HSV15)

Primary Purpose

Genital Herpes

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HSV 2 Formulation 1
HSV 2 Formulation 2
HSV 2 Formulation 3
HSV 2 Formulation 4
HSV 2 Formulation 5
HSV 2 Formulation 6
Sodium Chloride 0.9%
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria :

  • Aged 18 to 55 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits
  • HSV-2 seropositive confirmed by Western blot
  • A history of established HSV-2 infection ≥ 1 year
  • A history of at least 2 and no more than 9 reported HSV clinical recurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 2 and no more than 9 reported clinical recurrences in the 12 months prior to initiation suppressive therapy
  • For Part A and Part B, the participant is willing to refrain from using suppressive antiviral therapy starting 5 days before the first vaccination visit and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods, and up to 6 months after the second vaccination visit
  • For Part A and Part B, the participant is willing to refrain from using antiviral therapy to treat recurrences starting 5 days before V01 and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods (i.e., up to 60 days after the second vaccination visit)

Exclusion criteria:

  • For Part A, the participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 6 months after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
  • For Part B, the participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence with her/his partner from at least 4 weeks before the enrollment visit until at least 6 months after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
  • Participants whose female partners are pregnant at the time of enrollment or plan to become pregnant between study entry through 12 weeks (for Part A) and 6 months (for Part B) after the second vaccination visit.
  • Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination
  • Current alcohol abuse or drug addiction
  • Positive serologic test or polymerase chain reaction for human immunodeficiency virus type 1 infection
  • Positive hepatitis B surface antigen
  • Positive antibody for hepatitis C virusribonucleic acid and positive hepatitis C test
  • Severe active infection or serious HSV-2 related medical conditions on the day of enrollment that, in the opinion of the Investigator, would prevent study completion
  • Active genital herpes determined by the presence of outbreaks (genital lesions) at the time of enrollment. A prospective subject should not be included in the trial until 24 hours after the outbreak has resolved (the lesions have completely disappeared)
  • Hemoglobin, white blood cell count with differential, platelet count, renal function tests (serum creatinine, blood urea nitrogen), liver function tests, creatine phosphokinase and C-reactive protein screening laboratory results that fall into the range of values that are Grade 2 or greater as per the study toxicity grading scale for this study. Also the range of values that are Grade 1 and are deemed clinically significant in the opinion of the Investigator (Grade 1 values deemed not clinically significant may be enrolled at the Investigator's discretion)
  • Previous vaccination against HSV infection with either the trial vaccine or another vaccine against HSV
  • History of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis)
  • History of eczema herpeticum
  • History of herpes-associated erythema multiforme
  • History of lesions caused by HSV on either arm
  • History of any autoimmune disorder
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Known allergy or intolerance to nickel
  • Known allergy or intolerance to acyclovir or valacyclovir
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • Chronic illness or other conditions that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 °F ([≥ 38 °C]).

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Research Centers of America-Site Number:8400010
  • Brigham and Womens Hospital-Site Number:8400003
  • M3 Wake Research Inc-Site Number:8400006
  • University of Washington Virology Research Clinic-Site Number:8400001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Part A - Group 1

Part A - Group 2

Part A - Group 3

Part A - Group 4

Part A - Group 5

Part A - Group 6

Part B (Stage 1) - Group 1

Part B (Stage 1) - Group 2

Part B (Stage 1) - Group 3

Part B (Stage 1) - Group 4

Part B (Stage 1) - Group 5

Part B (Stage 1) - Group 6

Part B (Stage 1) - Group 7

Part B (Stage 2) - Group 1

Part B (Stage 2) - Group 2

Part B (Stage 2) - Group 3

Part B (Stage 2) - Group 4

Part B (Stage 2) - Group 5

Part B (Stage 2) - Group 6

Part B (Stage 2) - Group 7

Arm Description

HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2

HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2.

Sodium chloride 0.9% (in both arms) at Month 0 and Month 2

HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2

HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2

Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2

HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2

HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2

Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2

HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2

Outcomes

Primary Outcome Measures

Number of participants with immediate adverse events
Unsolicited systemic adverse events occurring immediately after vaccination
Number of participants with solicited injection site and systemic reactions
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Number of participants with unsolicited adverse events
An unsolicited adverse event is an event that does not fulfill the conditions prelisted in the Case Report Book in terms of diagnosis and/or onset post-vaccination
Number of participants with medically-attended adverse events (MAAEs)
An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department
Number of participants with adverse events of special interest (AESIs)
AESIs are collected throughout the study
Number of participants with serious adverse events (SAEs)
SAEs are collected throughout the study
Number of participants with out-of-range biological test results
Out-of-range biological test results area assessed at Days 8 and 30 after each vaccination and 15 days prior to second vaccination in Part A and Days 8 and 30 after each vaccination in Part B
Viral genital shedding rate
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination and those collected after the second vaccination visit
Genital HSV recurrence
Proportion of participants free of genital HSV recurrence following the second vaccination

Secondary Outcome Measures

Genital lesion rate
Total number of days that the participants who receive investigational product or placebo report genital herpes lesions following the second vaccination
Genital HSV recurrence
Number of recurrences of genital HSV following the second vaccination in participants who receive investigational product or placebo. Recurrence is defined as the appearance of genital and perineal lesions (i.e., shingles, blisters, ulcers) in a previously asymptomatic participant. Regarding 2 separate episodes of recurrences, recurrence is defined as the presentation of a new lesion (or lesions) after a 1-day-minimum (≥ 24 hours) lesion-free period
Viral genital shedding rate after the first and second vaccination
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit plus after the second vaccination visit in participants who receive investigational product or placebo
Viral genital shedding rate after the first vaccination
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit in participants who receive investigational product or placebo
Change in serum HSV 2-antibody levels
Change between pre-vaccination and post-first and second vaccinations
Change in level of HSV 2-specific cellular immune responses
Change between pre-vaccination and post-first and second vaccinations

Full Information

First Posted
January 7, 2020
Last Updated
October 21, 2022
Sponsor
Sanofi Pasteur, a Sanofi Company
Collaborators
Immune Design
search

1. Study Identification

Unique Protocol Identification Number
NCT04222985
Brief Title
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
Acronym
HSV15
Official Title
Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
Collaborators
Immune Design

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of the study are: To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). To evaluate the efficacy of the investigational vaccine regimens with respect to: the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
Detailed Description
Study duration per participant is approximately 16 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A - Group 1
Arm Type
Experimental
Arm Description
HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part A - Group 2
Arm Type
Experimental
Arm Description
HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part A - Group 3
Arm Type
Experimental
Arm Description
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part A - Group 4
Arm Type
Experimental
Arm Description
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Arm Title
Part A - Group 5
Arm Type
Experimental
Arm Description
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2.
Arm Title
Part A - Group 6
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% (in both arms) at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 1
Arm Type
Experimental
Arm Description
HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 2
Arm Type
Experimental
Arm Description
HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 3
Arm Type
Experimental
Arm Description
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 4
Arm Type
Experimental
Arm Description
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Arm Title
Part B (Stage 1) - Group 5
Arm Type
Experimental
Arm Description
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 6
Arm Type
Placebo Comparator
Arm Description
Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2
Arm Title
Part B (Stage 1) - Group 7
Arm Type
Experimental
Arm Description
HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 1
Arm Type
Experimental
Arm Description
HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 2
Arm Type
Experimental
Arm Description
HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 3
Arm Type
Experimental
Arm Description
HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 4
Arm Type
Experimental
Arm Description
HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2
Arm Title
Part B (Stage 2) - Group 5
Arm Type
Experimental
Arm Description
HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 6
Arm Type
Placebo Comparator
Arm Description
Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2
Arm Title
Part B (Stage 2) - Group 7
Arm Type
Experimental
Arm Description
HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 1
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 2
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 3
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 4
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 5
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
HSV 2 Formulation 6
Intervention Description
Route of administration: Intramuscular
Intervention Type
Biological
Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
Route of administration: Intramuscular
Primary Outcome Measure Information:
Title
Number of participants with immediate adverse events
Description
Unsolicited systemic adverse events occurring immediately after vaccination
Time Frame
Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination
Title
Number of participants with solicited injection site and systemic reactions
Description
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Time Frame
Within 7 days after vaccination
Title
Number of participants with unsolicited adverse events
Description
An unsolicited adverse event is an event that does not fulfill the conditions prelisted in the Case Report Book in terms of diagnosis and/or onset post-vaccination
Time Frame
Within 30 days after vaccination
Title
Number of participants with medically-attended adverse events (MAAEs)
Description
An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department
Time Frame
From Day 0 to Month 14
Title
Number of participants with adverse events of special interest (AESIs)
Description
AESIs are collected throughout the study
Time Frame
From Day 0 to Month 14
Title
Number of participants with serious adverse events (SAEs)
Description
SAEs are collected throughout the study
Time Frame
From Screening to Month 14
Title
Number of participants with out-of-range biological test results
Description
Out-of-range biological test results area assessed at Days 8 and 30 after each vaccination and 15 days prior to second vaccination in Part A and Days 8 and 30 after each vaccination in Part B
Time Frame
From Day 8 to Day 30
Title
Viral genital shedding rate
Description
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination and those collected after the second vaccination visit
Time Frame
60 days before first vaccination and 60 days after the second vaccination
Title
Genital HSV recurrence
Description
Proportion of participants free of genital HSV recurrence following the second vaccination
Time Frame
6 months following the second vaccination
Secondary Outcome Measure Information:
Title
Genital lesion rate
Description
Total number of days that the participants who receive investigational product or placebo report genital herpes lesions following the second vaccination
Time Frame
6 months after the second vaccination
Title
Genital HSV recurrence
Description
Number of recurrences of genital HSV following the second vaccination in participants who receive investigational product or placebo. Recurrence is defined as the appearance of genital and perineal lesions (i.e., shingles, blisters, ulcers) in a previously asymptomatic participant. Regarding 2 separate episodes of recurrences, recurrence is defined as the presentation of a new lesion (or lesions) after a 1-day-minimum (≥ 24 hours) lesion-free period
Time Frame
60 days following the second vaccination
Title
Viral genital shedding rate after the first and second vaccination
Description
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit plus after the second vaccination visit in participants who receive investigational product or placebo
Time Frame
60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the second vaccination
Title
Viral genital shedding rate after the first vaccination
Description
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit in participants who receive investigational product or placebo
Time Frame
60 days before and 60 days after the first vaccination
Title
Change in serum HSV 2-antibody levels
Description
Change between pre-vaccination and post-first and second vaccinations
Time Frame
Before and 30 days after the first and second vaccinations and 6 months after the second vaccination
Title
Change in level of HSV 2-specific cellular immune responses
Description
Change between pre-vaccination and post-first and second vaccinations
Time Frame
Before and 8 days after the first and second vaccination and 6 months after the second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria : Aged 18 to 55 years on the day of inclusion Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits HSV-2 seropositive confirmed by Western blot A history of established HSV-2 infection ≥ 1 year A history of at least 2 and no more than 9 reported HSV clinical recurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 2 and no more than 9 reported clinical recurrences in the 12 months prior to initiation suppressive therapy For Part A and Part B, the participant is willing to refrain from using suppressive antiviral therapy starting 5 days before the first vaccination visit and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods, and up to 6 months after the second vaccination visit For Part A and Part B, the participant is willing to refrain from using antiviral therapy to treat recurrences starting 5 days before V01 and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods (i.e., up to 60 days after the second vaccination visit) Exclusion criteria: For Part A, the participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 6 months after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. For Part B, the participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence with her/his partner from at least 4 weeks before the enrollment visit until at least 6 months after the last vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. Participants whose female partners are pregnant at the time of enrollment or plan to become pregnant between study entry through 12 weeks (for Part A) and 6 months (for Part B) after the second vaccination visit. Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination Current alcohol abuse or drug addiction Positive serologic test or polymerase chain reaction for human immunodeficiency virus type 1 infection Positive hepatitis B surface antigen Positive antibody for hepatitis C virusribonucleic acid and positive hepatitis C test Severe active infection or serious HSV-2 related medical conditions on the day of enrollment that, in the opinion of the Investigator, would prevent study completion Active genital herpes determined by the presence of outbreaks (genital lesions) at the time of enrollment. A prospective subject should not be included in the trial until 24 hours after the outbreak has resolved (the lesions have completely disappeared) Hemoglobin, white blood cell count with differential, platelet count, renal function tests (serum creatinine, blood urea nitrogen), liver function tests, creatine phosphokinase and C-reactive protein screening laboratory results that fall into the range of values that are Grade 2 or greater as per the study toxicity grading scale for this study. Also the range of values that are Grade 1 and are deemed clinically significant in the opinion of the Investigator (Grade 1 values deemed not clinically significant may be enrolled at the Investigator's discretion) Previous vaccination against HSV infection with either the trial vaccine or another vaccine against HSV History of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis) History of eczema herpeticum History of herpes-associated erythema multiforme History of lesions caused by HSV on either arm History of any autoimmune disorder Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Receipt of immune globulins, blood or blood-derived products in the past 3 months Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Known allergy or intolerance to nickel Known allergy or intolerance to acyclovir or valacyclovir Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study Chronic illness or other conditions that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4 °F ([≥ 38 °C]). The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Centers of America-Site Number:8400010
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Brigham and Womens Hospital-Site Number:8400003
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
M3 Wake Research Inc-Site Number:8400006
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University of Washington Virology Research Clinic-Site Number:8400001
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

We'll reach out to this number within 24 hrs