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

NCT ID: NCT04762511

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2021-05-26

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.

Conditions

Herpes Simplex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HSV lower dose formulation Group

Healthy participants, 18 to 40 years of age, receive two doses of the HSV lower dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.

Group Type: EXPERIMENTAL

Lower dose formulation of HSV vaccine (GSK4108771A)

Intervention Type: BIOLOGICAL

2 doses of the lower dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Placebo Step 1 Group

Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

HSV low dose formulation Group

Healthy participants, 18 to 40 years of age, receive two doses of the HSV low dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.

Group Type: EXPERIMENTAL

Low dose formulation of HSV vaccine (GSK4108771A)

Intervention Type: BIOLOGICAL

2 doses of the low dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Placebo Step 2 Group

Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

HSV medium dose formulation Group

Healthy participants, 18 to 40 years of age, receive two doses of the HSV medium dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.

Group Type: EXPERIMENTAL

Medium dose formulation of HSV vaccine (GSK4108771A)

Intervention Type: BIOLOGICAL

2 doses of the medium dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Placebo Step 3 Group

Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

HSV high dose formulation Group

Healthy participants, 18 to 40 years of age, receive two doses of the HSV high dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.

Group Type: EXPERIMENTAL

High dose formulation of HSV vaccine (GSK4108771A)

Intervention Type: BIOLOGICAL

2 doses of the high dose formulation of the HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Placebo Step 4 Group

Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.

Group Type: PLACEBO_COMPARATOR

Placebo (saline)

Intervention Type: DRUG

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Interventions

Lower dose formulation of HSV vaccine (GSK4108771A)

2 doses of the lower dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Intervention Type: BIOLOGICAL

Low dose formulation of HSV vaccine (GSK4108771A)

2 doses of the low dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Intervention Type: BIOLOGICAL

Medium dose formulation of HSV vaccine (GSK4108771A)

2 doses of the medium dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Intervention Type: BIOLOGICAL

High dose formulation of HSV vaccine (GSK4108771A)

2 doses of the high dose formulation of the HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Intervention Type: BIOLOGICAL

Placebo (saline)

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Rochester, New York, United States

Countries

United States

Other Identifiers

213830

Identifier Type: -

Identifier Source: org_study_id