Tetanus and diphtheria preventative vaccination Infections and Infestations
Conditions
Interventions
Two treatment groups of 80 participants will be randomised 1:1 using a paper-based randomisation process, in a single-blind manner to receive a single dose of SPVX02 or Tetadif®. Both treatment groups
Sponsors
Stablepharma Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Participant is 18-60 years of age at the time of screening with a BMI =34.9 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 has previously received primary and/or booster immunisation with diphtheria and tetanus vaccines, as confirmed by GP records. Alternatively, in the absence of complete vaccination records, the participant has detectable screening tetanus and diphtheria antibody titres of =0.01 IU/mL 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 IMP) 6.2. Intrauterine device (IUD) 6.3. Intrauterine hormone-releasing system (IUS) 6.4. Bilateral tubal occlusion/ligation 6.5. Male or female condom with or without spermicide 6.6. Cap, diaphragm or sponge with a vaginal spermicide 6.7. Vasectomised partner (the vasectomised partner should be the sole partner for that volunteer and have received a medical assessment of surgical success) 6.8. 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 an alternative medical cause 7.2. Permanently sterile: permanent sterilization methods include hysterectomy (removal of the womb), bilateral salpingectomy (surgical removal of the fallopian tubes), 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. Immune-mediated conditions that are stable and well-controlled (e.g.. Hashimoto thyroiditis) as well as those that do not require systemic immunosuppressants (e.g.. asthma, psoriasis, or vitiligo) may be permitted at the discretion of the Investigator and following discussion with the Medical Monitor. In participants with stable, treated hypothyroidism, mildly abnormal thyroid function tests may not be clinically significant and may be accepted at the discretion of the Investigator 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. HIV-positive participants on antiretroviral therapy with CD4 count =500 cells/mm3 and HIV RNA =500 copies/mL within the past 365 days, are permitted at the discretion of the Investigator. Hepatitis C or Hepatitis B infection, if well controlled on stable therapy, with normal liver function and no evidence of immunosuppression, may be permitted at the discretion of the Investigator and following discussion with the Medical Monitor 7. History of allergic disease or any suspected or known hypersensitivity to any of the SPVX02 or Tetadif 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 received an investigational intervention in the last 6 months, or within 5 half-lives, whichever is longer 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 breast feeding 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, as determined from medical review of GP records 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 within the last 5 years. Participants with a positive DOA result at screening may be included at the discretion of the Investigator only if the result is attributable to prescribed or over-the-counter medication or other legitimate use, and there is no evidence of substance abuse or dependency. All decisions must be justified and documented 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of seroprotection resulting from a single dose of SPVX02 or Tetadif®, 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of safety and reactogenicity events which include:, adverse events, serious adverse events, incidence of local and systemic reactogenicity events observed for 7 days post-dose which include: pain, induration /swelling, tenderness, warmth, erythema at the injection site plus feverishness, chills, myalgia, fatigue, headache, arthralgia and rash 2. Incidence of longer term seroprotection resulting from a single dose of SPVX02 or Tetadif®, 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 3. Evaluation of GMTs of anti-TT and anti-DT antibodies resulting from a single dose of SPVX02 or Tetadif® measured using enzyme linked immunosorbent assays (ELISAs) at 28 days post-dose | — |
Countries
United Kingdom
Contacts
Public ContactKaren O'Hanlon
Outcome results
None listed