Prevention of tetanus and diphtheria infection in healthy volunteers Infections and Infestations
Conditions
Interventions
The study will be conducted in 60 healthy participants who have previously received a primary vaccination against tetanus and diphtheria but who have not received a booster vaccination in the last 10
Sponsors
Stablepharma Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participant is 18-55 years of age at the time of screening with a BMI =30 kg/m2 2. Participant is able to provide informed consent indicating that they are willing to participate and that they understand the purpose of the study and the assessments they are required to undergo as part of their involvement in the study 3. Participant is considered to be in good health with no current conditions that may significantly impair participant safety or influence the study results, as determined by the Investigator 4. Participant does not have any medical condition that causes primary or secondary immunodeficiency 5. Participant confirms (via GP records, NHS mobile phone application, or similar) that they have previously received primary or booster immunisation with previous diphtheria and tetanus vaccines 6. Participants who were born female and are of child-bearing potential must be practicing an acceptable effective method of contraception for the duration of the study. Acceptable methods for this study include: 6.1. Hormonal contraception (use of hormonal contraception should start at least 28 days before the first administration of the study vaccine) 6.2. Intrauterine device (IUD) 6.3. Intrauterine hormone-releasing system (IUS) 6.4. Male or female condom with or without spermicide 6.5. Cap, diaphragm or sponge with a vaginal spermicide 6.6. Vasectomised partner (the vasectomised partner should be the sole partner for that volunteer) 6.7. Sexual abstinence (sexual abstinence is considered an effective method only if defined as refraining from heterosexual intercourse from signing the ICF until the end of the study) 7. Participants who were born female and are not of child-bearing potential must be: 7.1. Postmenopausal: amenorrhea (no menstrual periods) for at least 12 months without alternative medical cause. 7.2. Permanently sterile: permanent sterilization methods include hysterectomy (removal of the womb), bilateral salpingectomy (surgical removal of the fallopian tubes), bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy (surgical removal of both ovaries). 8. Male participants must be willing to use a contraception method upon enrolment, during the course of the study, and for 1 month post-dose.
Exclusion criteria
Exclusion criteria: 1. Serious and uncontrolled chronic disease (i.e., cardiac, pulmonary, renal, neurologic, metabolic, rheumatologic, etc) 2. Known or suspected autoimmune disease or impairment of immunological function of any cause 3. Acute medical illness, with or without fever, or an oral or tympanic temperature >38°C within the 72 hours prior to dosing. 4. Administration of immunoglobulin or other blood products within the last three months prior to screening; administration of corticosteroids (injected or oral) or other immunomodulatory therapy within 42 days prior to Day 1 5. A positive test result at screening for HIV, hepatitis C virus or hepatitis B virus 6. Received any vaccine in the 30 days prior to screening or planning to receive a vaccine in the 30 days following administration of the study vaccine 7. History of allergic disease or any suspected or known hypersensitivity to any of the SPVX02, Tetadif® or diTeBooster® components 8. Any history of anaphylaxis in reaction to a vaccination 9. Unable to attend scheduled visits or unable to comply with the study procedures 10. Enrolled in another interventional clinical study or has participated in an interventional clinical study in the last 6 months prior to Day 1. 11. Any condition that would pose a health risk to the participant or interfere with the evaluation of either vaccine in the opinion of the Investigator 12. Female and of childbearing potential who does not agree either to remain abstinent or to use effective birth control during the period of the study 13. Intending to become pregnant or breastfeeding during the period of the study. 14. A history of Guillain-Barré syndrome 15. Receipt of a tetanus or diphtheria vaccination within the 10 years prior to enrolment 16. A previous history of diphtheria or tetanus disease within the last 25 years 17. History of Arthus-type hypersensitivity reaction. 18. History of alcohol or substance abuse. 19. Unable to fulfil all the requirements of the study in the opinion of the Investigator. 20. Significant psychiatric history in the last 2 years. 21. Presence of permanent body art on both right and left upper arms that would obstruct the ability to observe local reactions at the injection site 22. Any other finding that, in the opinion of the Investigator or Sponsor, deems the subject unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of safety and reactogenicity events, which include adverse events , serious adverse events, and the incidence of local and systemic reactogenicity events observed for 7 days post-dose which include: pain, induration, tenderness, swelling, warmth, erythema at the vaccination site plus feverishness, chills, myalgia, fatigue, headache, arthralgia, rash measured using data collected from electronic Case Report Forms (eCRF) at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of seroprotection resulting from a single dose of SPVX02, Tetadif® or diTeBooster®; seroprotection is defined as an IgG serum antibody titre =0.1 IU/mL, which is the antibody titre level of anti-TT and anti-DT antibodies that are considered to confer protection against diphtheria and tetanus infection, measured using enzyme linked immunosorbent assays (ELISAs) at 28 days post-dose;Evaluation of geometric mean titers (GMTs) of anti-TT and anti-DT antibodies resulting from a single dose of SPVX02, Tetadif® or diTeBooster® measured using enzyme linked immunosorbent assays (ELISAs) at 28 days post-dose;Incidence of longer-term seroprotection resulting from a single dose of SPVX02, Tetadif® or diTeBooster®; longer-term seroprotection is defined as an antibody titre =1.0 IU/mL, which is the antibody titre level of anti-TT and anti-DT antibodies that are considered to confer longer-term protection against diphtheria and tetanus infection, measured using enzyme linked immunosorbent assays (ELISAs) at 28 days post-dose | — |
Countries
England, United Kingdom
Outcome results
None listed