Pertaprime: A study to assess the immune response and safety of a new pertussis vaccine (Pertagen®) in healthy young adults.
Pertaprime: An investigator-driven phase II-III randomised, observer-blind, controlled trial to demonstrate non-inferior immunogenicity of Pertagen® in comparison to Boostrix® in healthy young Australian adults aged 18-30 years.
Telethon Kids Institute
102 participants
Jul 1, 2020
Interventional
Conditions
Summary
This study will be investigating the use of a new whooping cough vaccine in adults aged 18 - 30 years. Pertussis infection rates within this age group have been rising since the early 2000s and this is likely due to the short-term protection offered by the current pertussis booster vaccine. The study will compare the use of this new vaccine to the vaccine currently used in Australia. Randomisation will be based on the pertussis vaccination history of each particular subject and all subjects will be followed up for one year. They will have blood sampled before vaccination, at 28 days following vaccination and 1 year after vaccination. The expected outcome is that the new pertussis vaccine will demonstrate superior immune response and therefore extended protection against pertussis.
Eligibility
Inclusion Criteria6
- Age 18 to less than 31 years old
- Provided written informed consent
- Proven history of having received as primary pertussis immunisations 3 doses of an aPchem-containing vaccine in the first year of life or at least as a first dose wP containing vaccine.
- Generally healthy as established by medical history and physical examination
- Capable to comply with the study protocol
- Negative urine pregnancy test for all females of child-bearing potential only (i.e. only females who have undergone sterilisation, hysterectomy or who are post-menopausal will not have a urine pregnancy test performed) and use of either a reliable method of contraception or abstinence during the first 2 months post-study vaccination.
Exclusion Criteria17
- History of significant medical illness such as immune deficiency, uncontrolled diabetes or hypertension heart or renal or hepatic diseases
- Pregnant or breast-feeding women
- History of allergy to any vaccine component
- History of serious adverse event or neurological adverse event after injection with any vaccine
- Having received any other vaccines within 28 days prior to recruitment (3 months for live attenuated vaccines)
- Plan to receive any other vaccines within 28 days after study-related Pertagen®/Boostrix® vaccination
- Plan to participate in another clinical trial of an investigational product during the study period (one year)
- History of receiving blood or blood component or immunoglobulin within 3 months prior to recruitment
- History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment
- Having received pertussis vaccine within 5 years prior to recruitment
- Having had whooping cough diagnosis or confirmed pertussis infection within 5 years prior to recruitment
- Presence of acute febrile illness on the day of vaccination (This is a temporary exclusion criterion)
- Any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome
- Behavioural or cognitive impairment or psychiatric disease that in the opinion of the investigator may interfere with the subject's ability to participate in the study
- History of alcoholism and/or clinically significant drug abuse
- Presence of bleeding disorders, and abnormalities of splenic and thymic functions
- Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
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Interventions
Pertagen® (Pertussis Toxoid 5 µg, Filamentous hemagglutinin 5 µg, Aluminum Hydroxide 0.3 mg/dose (as Al3+), Sodium Chloride 4.38 mg, water for injections quantity sufficient to make up to a volume of 0.5 mL). To be administered as a single 0.5mL dose injected intramuscularly, preferably into the non-dominant deltoid. The vaccine will be administered by appropriately trained study staff (nurses) delegated as unblinded vaccinators.
Locations(1)
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ACTRN12619000944134