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

Conditions: Herpes Simplex

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.

Keywords: first time in human vaccine healthy participants herpes simplex virus reactogenicity safety immune response