Genital HerpesPhase 1HSV15NCT04222985
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
A Phase 1 study testing HSV 2 Formulation 1, HSV 2 Formulation 2 and HSV 2 Formulation 3 in people with Genital Herpes, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Genital Herpes
- What is being tested?
- HSV 2 Formulation 1, HSV 2 Formulation 2 and HSV 2 Formulation 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2020to 19 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Womens Hospital-Site Number:8400003
Boston, Massachusetts, 02115
Research Centers of America-Site Number:8400010
Hollywood, Florida, 33024
M3 Wake Research Inc-Site Number:8400006
Raleigh, North Carolina, 27612
University of Washington Virology Research Clinic-Site Number:8400001
Seattle, Washington, 98104
About this study
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
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
Read more
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
Read the detailed description
Study duration per participant is approximately 16 months
- Conditions
- Genital Herpes
- Being tested
- HSV 2 Formulation 1, HSV 2 Formulation 2, HSV 2 Formulation 3, HSV 2 Formulation 4, HSV 2 Formulation 5
- Medical subject headings
- Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSV 2 Formulation 1Biological
Route of administration: Intramuscular
HSV 2 Formulation 2Biological
Route of administration: Intramuscular
HSV 2 Formulation 3Biological
Route of administration: Intramuscular
HSV 2 Formulation 4Biological
Route of administration: Intramuscular
HSV 2 Formulation 5Biological
Route of administration: Intramuscular
HSV 2 Formulation 6Biological
Route of administration: Intramuscular
Sodium Chloride 0.9%Biological
Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Part A - Group 1 | Experimental | HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 1; Biological: Sodium Chloride 0.9% |
| Part A - Group 2 | Experimental | HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 2; Biological: Sodium Chloride 0.9% |
| Part A - Group 3 | Experimental | HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 3; Biological: Sodium Chloride 0.9% |
| Part A - Group 4 | Experimental | 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 Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 4; Biological: Sodium Chloride 0.9% |
| Part A - Group 5 | Experimental | HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2. Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 5 |
| Part A - Group 6 | Placebo comparator | Sodium chloride 0.9% (in both arms) at Month 0 and Month 2 Receives: Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 1 | Experimental | HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 1; Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 2 | Experimental | HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 2; Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 3 | Experimental | HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 3; Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 4 | Experimental | 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 Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 4; Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 5 | Experimental | HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 5 |
| Part B (Stage 1) - Group 6 | Placebo comparator | Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 Receives: Biological: Sodium Chloride 0.9% |
| Part B (Stage 1) - Group 7 | Experimental | HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 6; Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 1 | Experimental | HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 1; Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 2 | Experimental | HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 2; Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 3 | Experimental | HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 3; Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 4 | Experimental | 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 Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 4; Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 5 | Experimental | HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 3; Biological: HSV 2 Formulation 5 |
| Part B (Stage 2) - Group 6 | Placebo comparator | Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 Receives: Biological: Sodium Chloride 0.9% |
| Part B (Stage 2) - Group 7 | Experimental | HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Receives: Biological: HSV 2 Formulation 6; Biological: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with immediate adverse events
Unsolicited systemic adverse events occurring immediately after vaccination
Measured: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) 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
Measured: Within 7 days after vaccination
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
Measured: Within 30 days after 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
Measured: From Day 0 to Month 14
Number of participants with adverse events of special interest (AESIs)
AESIs are collected throughout the study
Measured: From Day 0 to Month 14
Number of participants with serious adverse events (SAEs)
SAEs are collected throughout the study
Measured: From Screening to Month 14
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
Measured: From Day 8 to Day 30
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
Measured: 60 days before first vaccination and 60 days after the second vaccination
Genital HSV recurrence
Proportion of participants free of genital HSV recurrence following the second vaccination
Measured: 6 months following the second vaccination
Secondary outcomes (6)
Genital lesion rate
Total number of days that the participants who receive investigational product or placebo report genital herpes lesions following the second vaccination
Measured: 6 months after 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
Measured: 60 days following the second vaccination
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
Measured: 60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the second vaccination
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
Measured: 60 days before and 60 days after the first vaccination
Change in serum HSV 2-antibody levels
Change between pre-vaccination and post-first and second vaccinations
Measured: Before and 30 days after the first and second vaccinations and 6 months after the second vaccination
Change in level of HSV 2-specific cellular immune responses
Change between pre-vaccination and post-first and second vaccinations
Measured: Before and 8 days after the first and second vaccination and 6 months after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start18 Feb 2020
- Primary completion19 May 2021
- Study completion19 May 2021
Why it stopped: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222985
- Sponsor's protocol ID
- HSV15
- Other IDs
- U1111-1183-6522
- Acronym
- HSV15
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04222985
- Acronym / sponsor ID
- HSV15 / HSV15
- Conditions
- Genital Herpes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Part A - Group 1 | Experimental | Biological: HSV 2 Formulation 1, Biological: Sodium Chloride 0.9%HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part A - Group 2 | Experimental | Biological: HSV 2 Formulation 2, Biological: Sodium Chloride 0.9%HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part A - Group 3 | Experimental | Biological: HSV 2 Formulation 3, Biological: Sodium Chloride 0.9%HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part A - Group 4 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 4, Biological: Sodium Chloride 0.9%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 |
| Part A - Group 5 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 5HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2. |
| Part A - Group 6 | Placebo comparator | Biological: Sodium Chloride 0.9%Sodium chloride 0.9% (in both arms) at Month 0 and Month 2 |
| Part B (Stage 1) - Group 1 | Experimental | Biological: HSV 2 Formulation 1, Biological: Sodium Chloride 0.9%HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 1) - Group 2 | Experimental | Biological: HSV 2 Formulation 2, Biological: Sodium Chloride 0.9%HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 1) - Group 3 | Experimental | Biological: HSV 2 Formulation 3, Biological: Sodium Chloride 0.9%HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 1) - Group 4 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 4, Biological: Sodium Chloride 0.9%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 |
| Part B (Stage 1) - Group 5 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 5HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 |
| Part B (Stage 1) - Group 6 | Placebo comparator | Biological: Sodium Chloride 0.9%Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 |
| Part B (Stage 1) - Group 7 | Experimental | Biological: HSV 2 Formulation 6, Biological: Sodium Chloride 0.9%HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 2) - Group 1 | Experimental | Biological: HSV 2 Formulation 1, Biological: Sodium Chloride 0.9%HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 2) - Group 2 | Experimental | Biological: HSV 2 Formulation 2, Biological: Sodium Chloride 0.9%HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 2) - Group 3 | Experimental | Biological: HSV 2 Formulation 3, Biological: Sodium Chloride 0.9%HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
| Part B (Stage 2) - Group 4 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 4, Biological: Sodium Chloride 0.9%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 |
| Part B (Stage 2) - Group 5 | Experimental | Biological: HSV 2 Formulation 3, Biological: HSV 2 Formulation 5HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 |
| Part B (Stage 2) - Group 6 | Placebo comparator | Biological: Sodium Chloride 0.9%Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 |
| Part B (Stage 2) - Group 7 | Experimental | Biological: HSV 2 Formulation 6, Biological: Sodium Chloride 0.9%HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSV 2 Formulation 1Route of administration: Intramuscular | Biological | Part A - Group 1, Part B (Stage 1) - Group 1, Part B (Stage 2) - Group 1 |
| HSV 2 Formulation 2Route of administration: Intramuscular | Biological | Part A - Group 2, Part B (Stage 1) - Group 2, Part B (Stage 2) - Group 2 |
| HSV 2 Formulation 3Route of administration: Intramuscular | Biological | Part A - Group 3, Part A - Group 4, Part A - Group 5, Part B (Stage 1) - Group 3, Part B (Stage 1) - Group 4, Part B (Stage 1) - Group 5, Part B (Stage 2) - Group 3, Part B (Stage 2) - Group 4, Part B (Stage 2) - Group 5 |
| HSV 2 Formulation 4Route of administration: Intramuscular | Biological | Part A - Group 4, Part B (Stage 1) - Group 4, Part B (Stage 2) - Group 4 |
| HSV 2 Formulation 5Route of administration: Intramuscular | Biological | Part A - Group 5, Part B (Stage 1) - Group 5, Part B (Stage 2) - Group 5 |
| HSV 2 Formulation 6Route of administration: Intramuscular | Biological | Part B (Stage 1) - Group 7, Part B (Stage 2) - Group 7 |
| Sodium Chloride 0.9%Route of administration: Intramuscular | Biological | Part A - Group 1, Part A - Group 2, Part A - Group 3, Part A - Group 4, 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 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 6, Part B (Stage 2) - Group 7 |
Primary outcome
Number of participants with immediate adverse events
Time frame: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination
Unsolicited systemic adverse events occurring immediately after vaccination
Number of participants with solicited injection site and systemic reactions
Time frame: Within 7 days after vaccination
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
Time frame: Within 30 days after vaccination
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)
Time frame: From Day 0 to Month 14
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)
Time frame: From Day 0 to Month 14
AESIs are collected throughout the study
Number of participants with serious adverse events (SAEs)
Time frame: From Screening to Month 14
SAEs are collected throughout the study
Number of participants with out-of-range biological test results
Time frame: From Day 8 to Day 30
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
Time frame: 60 days before first vaccination and 60 days after the second vaccination
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
Time frame: 6 months following the second vaccination
Proportion of participants free of genital HSV recurrence following the second vaccination
6 secondary outcomes
Genital lesion rate
Time frame: 6 months after the second vaccination
Genital HSV recurrence
Time frame: 60 days following the second vaccination
Viral genital shedding rate after the first and second vaccination
Time frame: 60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the second vaccination
Viral genital shedding rate after the first vaccination
Time frame: 60 days before and 60 days after the first vaccination
Change in serum HSV 2-antibody levels
Time frame: Before and 30 days after the first and second vaccinations and 6 months after the second vaccination
Change in level of HSV 2-specific cellular immune responses
Time frame: Before and 8 days after the first and second vaccination and 6 months after the second vaccination
Results and safety
The study was stopped early (reason given: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSV 2 Formulation 1, HSV 2 Formulation 2 and HSV 2 Formulation 3 in people with Genital Herpes, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with immediate adverse events (time frame: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.