Status:
TERMINATED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Simplex
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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) vac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04762511
Start Date
March 2 2021
End Date
May 26 2021
Last Update
June 28 2021
Active Locations (2)
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1
GSK Investigational Site
Lenexa, Kansas, United States, 66219
2
GSK Investigational Site
Rochester, New York, United States, 14609