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
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
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Written informed consent obtained from the participant prior to performance of any study-specific procedure.
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Healthy participants as established by medical history and clinical examination before entering into the study.
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Man or woman aged 18-40 years, included, at the time of the first vaccination.
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Women of non-childbearing potential may be enrolled in the study.
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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.
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Seronegative for HIV, as determined by laboratory screening tests. Participants documented to be positive to HIV will not be eligible for study participation.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
17 participants in 8 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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