A phase II randomized, observer-blind, active-controlled study to evaluate the immunogenicity and the safety of BioNet recombinant pertussis vaccines with different doses of genetically detoxified pertussis toxin (PTgen) when administered to healthy pregnant wome
- Conditions
- Pertussis vaccinePertussis
- Registration Number
- TCTR20210128004
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 232
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Geometric mean of pertussis toxin (PT)-specific serum antibodies concentration (GMC) At day 28 following immunization in maternal participant ELISA
- Secondary Outcome Measures
Name Time Method