Clinical trial NCT04762511: A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
Official title: A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Herpes Simplex
Keywords: First Time in Human
Vaccine
Healthy participants
Herpes Simplex Virus
Reactogenicity
Safety
Immune response
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.


Eligibility criteria: Inclusion Criteria:

* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Healthy participants as established by medical history and clinical examination before entering into the study.
* Man or woman aged 18-40 years, included, at the time of the first vaccination.
* Women of non-childbearing potential may be enrolled in the study.
* Women of childbearing potential may be enrolled in the study, if the participant:

  * Has practiced adequate contraception for one month prior to vaccination, and;
  * Has a negative pregnancy test result on the day of vaccination, and;
  * Has agreed to continue adequate contraception until the end of the study.
* Seronegative for HIV, as determined by laboratory screening tests. Participants documented to be positive to HIV will not be eligible for study participation.
* Seronegative for HSV-2 as determined by Western blot.

Exclusion Criteria:

Medical Conditions

* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Hypersensitivity to latex.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Recurrent history or uncontrolled neurological disorders or seizures.
* Grade 2 or higher haematological and/or biochemical laboratory abnormality at screening.
* Body mass index ≤ 18 kg/m\^2 or ≥ 35 kg/m\^2.
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
* Participants with symptoms suggestive of Coronavirus disease 2019 (COVID-19) infection within 14 days before the first study vaccination. Participants should be free of symptoms for at least 14 days.
* Participants with known COVID-19-positive contacts in the past 14 days before the first study vaccination.

Prior/Concomitant Therapy

* Use of any investigational or non-registered product other than the study vaccines during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
* Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study vaccine administration.
* Administration of long-acting immune-modifying drugs at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting three months before the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting three months prior to the first study vaccine dose. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Prior receipt of another vaccine containing HSV-2 antigens. Prior/Concurrent Clinical Study Experience
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.

Other Exclusions

* Pregnant or lactating woman.
* Woman planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1
timeFrame: Within 7 days after the first vaccine dose (administered at Day 1)
measure: Percentage of participants reporting solicited administration site events within 7 days after the second vaccine dose administered at Day 57
timeFrame: Within 7 days after the second vaccine dose (administered at Day 57)
measure: Percentage of participants reporting solicited systemic events within 7 days after the first vaccine dose administered at Day 1
timeFrame: Within 7 days after the first vaccine dose (administered at Day 1)
measure: Percentage of participants reporting solicited systemic events within 7 days after the second vaccine dose administered at Day 57
timeFrame: Within 7 days after the second vaccine dose (administered at Day 57)
measure: Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the first vaccine dose administered at Day 1
timeFrame: Within 28 days after the first vaccine dose (administered at Day 1)
measure: Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the second vaccine dose administered at Day 57
timeFrame: Within 28 days after the second vaccine dose (administered at Day 57)
measure: Percentage of participants reporting medically attended AEs (MAEs)
timeFrame: From Day 1 up to study end at Day 421
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: From Day 1 up to study end at Day 421
measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs)
timeFrame: From Day 1 up to study end at Day 421
measure: Percentage of participants reporting potential orolabial HSV-1 recurrence
timeFrame: From Day 1 up to study end at Day 421
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-vaccination (Day 1)
timeFrame: At pre-vaccination (Day 1)
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 2
timeFrame: At Day 2
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8
timeFrame: At Day 8
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57
timeFrame: At Day 57
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 58
timeFrame: At Day 58
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64
timeFrame: At Day 64
measure: Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 85
timeFrame: At Day 85
Secondary outcomes:
measure: Anti-vaccine antibody concentrations
timeFrame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
measure: Percentage of seropositive participants for anti-vaccine antibodies
timeFrame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
measure: Frequency of antigen specific Cluster of Differentiation (CD)4+ T-cells expressing at least two activation markers
timeFrame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
measure: Frequency of antigen-specific CD8+ T-cells expressing at least two activation markers
timeFrame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: