Vaccine responses in infants after acellular pertussis vaccination during pregnancy in Thailand

Phase 4

Completed

• Conditions: Interference of maternal antibodies on infants immune responses; pertussis; acellular vaccine; whole cell pertussis vaccine; antibody responses; cellular immune responses

• Registration Number: TCTR20180926001
• Lead Sponsor: The Thrasher Research Fund

Brief Summary

Maternal Tdap vaccination inhibited more pertussis-specific responses in wP-vaccinated infants compared to aP-vaccinated infants, and the control group of unvaccinated women had highest PT-specific responses, persisting until after the booster dose. Antibody functionality was better in the wP groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2018-03-07
• Study Completion: 2018-07-05
• Study Start: 2018-09-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 370

Inclusion Criteria

This study enrolled 370 pregnant Thai women who visited the antenatal care clinic at King Chulalongkorn Memorial Hospital and consented to Tdap vaccination during their third trimester of pregnancy
Inclusion Criteria for pregnant women
1.Women aged 18-40 years
2.Willing to be immunized with a pertussis containing vaccine during pregnancy at GA 27-36 weeks gestation
3.Intend to be available for follow-up visits and phone call through 19 months postpartum
4.Willing to have infant immunized with a pertussis containing vaccine at 2, 4, 6 months and 18 months of age the randomized aP or wP vaccine
5.At low risk for pregnancy related complications as determined by the investigator and a second trimester ultrasound with no significant abnormalities

Exclusion Criteria

Exclusion criteria for pregnant women
Pregnant women who meet any exclusion criteria at baseline will be excluded from the study.
1. Multiple pregnancies
2. Serious obstetrical risk:
- incompetent cervix
- known placenta previa
- preeclampsia not responding to state of the art treatment
- thyroid diseases not responding to state of the art treatment
- gestational hypertension not responding to state of the art treatment
- diabetes gravidarum
- grand multiparae (>5 pregnancies and deliveries)
- history of PPROM or preterm deliveries <37 weeks
- history of early onset preeclampsia (less than 34 weeks) in previous pregnancies
- repeated (more than three) lost pregnancies
- serious congenital defects in previous children or pregnancies
- any medical condition that shows a risk according to the medical doctors in charge
3. Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections, primary immune deficiencies)
4. Significant mental illness (e.g. schizophrenia, psychosis, major depression)
5. History of a febrile illness (greater than or equal to 38 degree Celsius) within the past 72 hours before injection. Vaccination can be postponed to a later moment if this is the only exclusion criterion
6. Previous severe reaction to any vaccine
7. Receipt of tetanus-diphtheria toxoid immunization within the past 1 month (except for the control group)
8. Receipt of a pertussis containing vaccine (Tdap) immunization in the last 5 years
9. Receipt of a vaccine, blood product (excluding Rhogam) within the 4 weeks prior to injection through 4 weeks following injection and IVIG within 12 weeks period. One month interval should be respected with another vaccine (except influenza) in order to evaluate eventual adverse events following one of both vaccines.
10.Receipt of an experimental drug during pregnancy
11. Anything in the opinion of the investigator that would prevent women from completing the study or put the woman at risk

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
antibody levels among infants in different groups matenral blood, cord blood, infant blood at 2,7,18,19 months ELISA

Secondary Outcome Measures

Name	Time	Method
Difference in T cell-mediated immune responses infant blood at 7,18,19 months cytokine level in cell culture supernantant