Pertussis vaccine Pertussis
Conditions
Interventions
Reduced recombinant acellular pertussis (ap) vaccine given intramuscularly as a single dose (0.5 ml) on day 0,Reduced recombinant acellular pertussis (ap) vaccine given intramuscularly as a single dos
Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
BioNet recombinant ap1gen,BioNet recombinant ap2gen,BioNet recombinant ap5gen,BioNet recombinant Tdap2gen,BioNet recombinant TdaP5gen,Licensed Tdapchem
Sponsors
Chulalongkorn University
BioNet-Asia Co., Ltd. 19 Soi Udomsuk 37, Sukhumvit 103 Rd., Prakanong, Bangkok 10260, Thailand
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: A. Pregnant Women Participant will be eligible for inclusion if ALL of the following criteria are met 1. Healthy, as established by medical history, physical examination, and obstetrical risk assessment 2 Uncomplicated singleton pregnancy 3 18 to 40 years of age 4. Documentation of gestational age determined based on last menstrual period or ultrasound 5. Gestational age at or more than 20 weeks, but less than 33 weeks 6. Willing and able to provide written informed consent 7. Willing and able to understand and comply with the study protocol within the principal investigator of judgement
Exclusion criteria
Exclusion criteria: A. Pregnant Women A. participant with ANY of the following criteria at study entry will not be eligible for participation 1. Any significant congenital abnormality, as documented by ultrasound 2. History of significant medical illness such as immune deficiency, (including HIV infection and transplant recipients), cardiovascular (including hypertension), endocrine, renal or hepatic disease. 3. Pregnancy complications (in the current pregnancy) such as hypertension (blood pressure (BP) more than 140/90 in the presence of proteinuria or BP more than 150/100 with or without proteinuria) or currently on an antihypertensive therapy, or pre-eclampsia, or eclampsia 4. Endocrine disorders including (but not limited to) hyperthyroidism, untreated hypothyroidism, and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or first occurring during pregnancy and requires interventions other than diet for control 5. Prior stillbirth or neonatal death, or multiple (at or more than 3) spontaneous abortions 6. Prior preterm delivery GA less than 37 weeks or ongoing intervention (medical or surgical) in the current pregnancy to prevent preterm birth 7. Greater than five (5) prior deliveries 8. History of allergy to any vaccine component 9. History of neurological adverse event after injection with any vaccine 10. Having received any other vaccines within 28 days prior to receive the study vaccine (3 months for live-attenuated vaccines) 11. Planning to participate in another clinical trial during the study period 12. History of receiving blood or blood component or immunoglobulin (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to recruitment 13. History of receiving immunosuppressive drugs or systemic corticosteroid (more than 0.5 mg/kg/day of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment 14. Having received diphtheria or tetanus or pertussis-containing vaccine or experienced a physician-diagnosed pertussis illness within 1 year prior to recruitment 15. Presence of acute febrile illness (defined as axillary temperature at or more than 38 degree celsius) on the day of vaccination (a temporary exclusion criterion) 16. Individuals with any progressive or severe neurological disorder, seizure disorder or a history of Guillain-Barre syndrome 17. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with their ability to participate in the study 18. Any history of smoking, alcoholism, and/or intravenous drug abuse, which in the opinion of the investigator will interfere with the study outcome evaluation 19. Presence of bleeding disorders, including deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy and abnormalities of splenic or thymic functions 20. Individuals with history of any illness or condition that, in the opinion of the investigator or obstetrician, would classify the pregnancy as high-risk, pose additional risk to the mother or fetus/infant due to participation in the study, or interfere with the results of the study. B. Infants If an infant meets ANY of the following criteria at birth, vaccination may be delayed or suspended according to the investigator of judgement. In this case, the infant will be referred to his/her primary care provider and the mother-infant pair will continue to be monitored for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean of pertussis toxin (PT)-specific serum antibodies concentration (GMC) At day 28 following immunization in maternal participant ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean of anti-PT antibody concentration At baseline and at the time of delivery ELISA,Geometric mean of anti-FHA antibodies concentration At baseline, day 28 after vaccination and at delivery time ELISA,Percentage of maternal participants with a four-fold or higher response in anti-PT and anti-FHA antibodies concentrations At 28 days after vaccination, at delivery ELISA,Percentage of maternal participants with anti-tetanus and anti-diphtheria antibodies concentrations At baseline, at 28 days following immunization and at delivery ELISA,Geometric mean of anti-tetanus and anti-diphtheria antibodies concentrations At baseline, at 28 days following immunization and at delivery ELISA,Geometric mean of PT-neutralizing antibodies titer (GMT) At baseline, at 28 days following immunization and at delivery PT neutralizing assay in CHO cells,Percentage of the subset of maternal participants with a four-fold or higher increase in PT-neutralizing antibodies titer At 28 days following immunization and delivery PT neutralizing assay in CHO cells,Percentage of maternal participants with solicited local and systemic adverse events (AEs) Within 7 day after vaccination Solicited local and AEs reported by participant,Percentage of maternal participants with unsolicited AEs Within 28 days following immunization Unsolicited AEs reported by participant ,Percentage of maternal participants with serious adverse events (SAEs) From vaccination date until study end of infant SAEs reported by participant ,Percentage of maternal subjects with medically attended AEs From day of vaccination until study end of infant Medically attended AEs reported,Percentage of maternal participants with the post-immunization onset of specific complications of pregnancy and delivery Post immunization until delivery The specific complications of pregnancy and delivery reported ,Percentage of maternal participants with AE leading to withdrawal from the study After enrollment until study of maternal end | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
Bionet-Asia Co., Ltd.
Outcome results
None listed