Immunogenicity and safety of various recombinant acellular pertussis-containing vaccines in healthy pregnant wome
- Conditions
- Pertussis
- Registration Number
- TCTR20180725004
- Lead Sponsor
- BioNet-Asia Co., Ltd. 19 Soi Udomsuk 37, Sukhumvit 103 Rd., Prakanong, Bangkok 10260, Thailand
- Brief Summary
This phase II trial met its primary objective of assessing the immunogenicity of BioNet vaccines relative to Boostrix, based on anti-PT antibody assessed by ELISA 28 days after vaccine injection in pregnant women and women of childbearing age. Anti-PT ELISA antibody GMC 28 days after one dose of BioNet ap-1,1, BioNet Tdap-1,1, or Tdap-2,5 vaccine, or Boostagen was non-inferior to that after one dose of Boostrix. BioNet vaccines had a good safety profile. Their safety profile was similar to Boostrix.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 388
1. Healthy, as established by medical history, physical examination, and obstetrical risk assessment
2. Uncomplicated singleton pregnancy
3. 18-40 years of age
4. Documentation of gestational age based on last menstrual period, physical exam, and ultrasound
5. Pregnancy at greater than or equal to 20 weeks gestational age, but prior to 33 weeks
6. Willing and able to provide written informed consent
7. Willing and able to understand and comply with the study protocol in the principal investigator's judgement
(Maternal subject)
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) hypertension or other cardiovascular disease, or renal or hepatic diseases
3. Pregnancy complications (in the current pregnancy) such as hypertension (blood pressure [BP] greater than 140/90 in the presence of proteinuria or BP greater than 150/100 with or without proteinuria) or currently on an antihypertensive therapy, or pre-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 occurring during pregnancy and requiring interventions other than diet for control
5. Prior stillbirth or neonatal death, or multiple (greater than or equal to 3) spontaneous abortions
6. Prior preterm delivery less than 37 weeks gestation, 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 recruitment (3 months for live attenuated vaccines)
11. Plan 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 (greater than 0.5 mg/kg 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 above 38 degree celsius) on the day of vaccination (This is a temporary exclusion criterion)
16. Individuals with any progressive or severe neurological disorder, seizure disorder or with 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 the subject's 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 and 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, interfere with the results of the study, or pose additional risk to the mother or fetus/infant due to participation in the study
(Infant subject)
1. Birth weight less than or equal to 2,000 grams
2. Serious underlying medical condition
3. Anything in the opinion of the investigator that would prevent the infant from participating in the study or would put the child at risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Geometric mean of pertussis toxin (PT)-specific serum antibody concentration (GMC) at 28 days after vaccination ELISA
- Secondary Outcome Measures
Name Time Method