Antibody level in cord sera following immunization with recombinant acellular pertussis vaccines during pregnancy: a prospective, observational study

Completed

• Conditions: Pertussis vaccine; Pertussis, maternal immunization, antibody transfer, pertussis vaccine, recombinant pertussistoxin.

• Registration Number: TCTR20200528006
• Lead Sponsor: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

Brief Summary

This prospective observational study supports existing research that outlines how recombinant pertussis vaccines (Boostagen and Pertagen) are safe for pregnant women. There were no vaccine-related adverse events on pregnancy or newborn health. Study results also showed the maternal immunization of recombinant pertussis vaccines can induce high level anti-PT and anti-FHA antibodies response that can be transferred from mothers to their infants.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-05-21
• Study Start: 2020-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 572

Inclusion Criteria

Pregnant women will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
1. Age of 18 to 40 years at the time of pregnancy
2. Received one dose of Pertagen or Boostagen vaccine or Td vaccine (several brands for Td vaccine) during pregnancy
3. Ultrasound assessment at 18 to 22 weeks of gestation showed no fetal structural abnormality
4. Uncomplicated singleton pregnancy
5. Having completed and relevant medical records available
6. Wiling and able to provide written informed consent for cord blood collection

Exclusion Criteria

Subjects with any of the following criteria at study entry will not be eligible for participation
1. Any significant congenital abnormality confirmed by ultrasound
2. Fetal abnormality, stillbirth or neonatal death
3. Received pertussis vaccine within 1 year prior to current pregnancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GMCs of anti PT-neutralizing, anti-PT and anti-FHA IgG titres in cord sera At delivery time CHO cell assay and ELISA ,Seropositive rates of anti-PT GMCs in infants base on antibody levels in cord sera At delivery time ELISA

Secondary Outcome Measures

Name	Time	Method
umber and percentage of pregnancy and neonatal outcomes at delivery and after delivery At delivery and after delivery Record form ,Seropositive rates of anti-PT GMCs in infants based on antibody levels in cord sera At delivery time ELISA