Prevention of Infections With Bordetella Pertussis Clinical Trial
Official title:
Clinical Study to Generate a Set of Data Characterising Clinical Events, Physiological Responses, and Innate and Adaptive Immune Responses Following a Single IM Immunisation With Boostrix® or Placebo in Healthy Adults
| Verified date | December 2022 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. 240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of Boostrix on Day 0, 20 will receive a placebo on Day 0.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | December 15, 2016 |
| Est. primary completion date | December 15, 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: 1. Healthy male or female subjects aged 18-45 years (inclusive). 2. Male: Female ratio - 1:1. 3. Half of the subjects (n=120) will have received a previous Dt(pa) dose less than 5 years before, the other half (n=120) will have received a previous Dt(pa) dose 5 or more years before participating at this study. 4. The subject is, in the opinion of the investigator healthy based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints. 5. Has a body Mass Index =18.0 and =30.0 6. Is able to read and understand the Informed Consent Form (ICF), and understand study procedures. 7. The subject has signed the ICF. 8. The subject is available for follow-up for the duration of the study. 9. The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary. 10. If the subject is a heterosexually active female, she is willing to use an effective method of contraception with partner (oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; condoms incorporating spermicide if using these; physiological or anatomical sterility) from 30 days prior to, and 3 months after, vaccination. Willing to undergo urine pregnancy tests prior to vaccination at screening. 11. The subject has venous access sufficient to allow blood sampling as per the protocol. Exclusion Criteria: 12. Pregnant or lactating at any point during the study from screening to final follow up. 13. Hypersensitivity to any component of the vaccine or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines. 14. Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral or parenteral corticosteroids). 15. Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1. 16. Regular and prolonged use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses. 17. Current intake of excessive amounts of alcohol and/or caffeine (as evaluated by the investigator) and not willing to adapt this use during the study period. 18. Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this use during the study period. 19. Receipt of a vaccine within 30 days prior to visit 1, or requirement to receive a vaccine within the 28 days following study vaccination, vaccination with a tetanus, diphtheria, pertussis combined vaccine within the last 6 months before the first study visit. 20. Presence of an acute severe febrile illness at time of immunisation. 21. History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1. 22. Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit 1. 23. Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study. 24. Receipt of blood products or immunoglobulins, or blood donation within 3 months prior to visit 1. 25. Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Center for Vaccinology | Ghent | East-Flanders |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | deCODE genetics, GlaxoSmithKline, Innovative Medicines Initiative, Max Planck Institute for Infection Biology, Novartis Vaccines, Sanofi Pasteur, a Sanofi Company, University of Surrey |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of local vaccine-related clinical events | Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe) | At all timepoints from vaccination up to 28 days after vaccination | |
| Primary | Frequency of systemic vaccine-related clinical events. | Participants will report these events on a diary, scoring them from 0 (absent) to 3 (severe) | At all timepoints from vaccination up to 28 days after vaccination | |
| Primary | Physiological assessments: Change from pre-immunisation baseline values in body temperature. | Up to 7 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in 'Erythrocyte Sedimentation Rate' (ESR) | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in creatinin | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in C Reactive Protein (CRP) | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in aspartate transaminase (AST)/ alanine transaminase (ALT) | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in albumin | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in estimated glomerular filtration rate (eGFR) | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in gamma glutamyl transpeptidase (GGT) | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in total protein | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in prothrombin/fibrinogen | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in global gene expression measured on whole blood samples. | At selected timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in metabolic gene expression measured on whole blood samples. | At selected timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in serum levels of antibodies to vaccine antigens (anti-T, anti-D, anti-PT, anti-FHA and anti-PRN) in serum samples. | At selected timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation values of adaptive cellular immune response via enumeration of TT-, DT-, PT-, FHA- and PTN-specific CD3/CD4+ or CD3/CD8+ T cells expressing activation markers/cytokines following IV stimulation and analysis by flow cytometry. | At 7 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples | At selected timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in pathway activation measured on whole blood samples. | At selected timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in haemoglobin | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in red blood cell count | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in haematocrit | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in white blood cell count | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in platelet count | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in white blood cells | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in 'mean corpuscular volume' | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin' | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in 'mean corpuscular heamoglobin concentration' | At all timepoints from vaccination up to 28 days after vaccination | ||
| Primary | Change from pre-immunisation baseline values in Cell Mediated Immunity status in response to in vitro antigen stimulation | At all timepoints from vaccination up to 28 days after vaccination |