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Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants

Pertussis Immunization During Pregnancy: Assessment of the Role of Maternal Antibodies on Immune Responses in Term and Preterm Infants: the MAMA Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02511327
Acronym
MAMA
Enrollment
232
Registered
2015-07-30
Start date
2015-01-31
Completion date
Unknown
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis

Keywords

Pertussis, Pregnancy, Vaccination, Preterm, Breast milk, Humoral immune response, Cellular immune response, Maternal antibodies

Brief summary

Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are transferred actively to the fetus. Administration of a pertussis containing vaccine during pregnancy offers protection through high titers of maternal antibodies transferred to the child. Since transplacental transport is immature, infants who are born prior to 37 weeks of gestation, might be vulnerable to pertussis infection even though maternal vaccination was administered, but specific data are lacking. The primary aim of this observational study is to measure whether vaccination during pregnancy offers protection to preterm born infants through higher titers of maternal antibodies, despite immature transplacental transport. Four cohorts of mother-infant pairs will be recruited: term versus preterm born infants, born from either vaccinated women or not vaccinated women. These mother-infant pairs are recruited according to the vaccination status of the mother and to the gestational age at delivery. Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous haemagglutinin, anti-Pertactin titers) will be monitored in blood samples of the mothers at delivery to measure the possible influence of both gestational age and maternal vaccination status. In order to measure the decline of maternal antibodies in the first weeks of life, blood will be taken from cords as well as from infants at 8 weeks of age, before the first infant pertussis vaccine is administered. Pertussis antibodies to the same antigens will be measured in all infants after a primary series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before and after a booster dose in the second year of life. In addition, cellular mediated immune responses will be evaluated in a subgroup of infants before and after a primary series of infants vaccines. A last goal is to measure whether vaccination during pregnancy could offer additional maternal antibodies through breast milk. Again a comparison is made between preterm and term born infants, born from either vaccinated or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA in breast milk samples will be measured in samples taken at birth (colostrum), and at several time points afterwards as long as breastfeeding is continued.

Interventions

DRUGInfant pertussis vaccination

Infants receive pertussis vaccines according to the national recommended schedule

Sponsors

University Hospital, Antwerp
CollaboratorOTHER
Université Libre de Bruxelles
CollaboratorOTHER
Research Foundation Flanders
CollaboratorOTHER
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

for participating women: * Pregnancy * Signed informed consent * Intend to be available for follow-up visits and phone call access through 16 months following delivery * Willing to have infant immunized with hexavalent vaccine according to the recommended Belgian schedule

Exclusion criteria

for participating women: * Significant mental illness (e.g. schizophrenia, psychosis, major depression) * Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection) * Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk * Receipt of a blood product or experimental medicine within 4 weeks prior to delivery * Multiple pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Titers of maternal pertussis specific antibodiesFrom birth until 8 weeks of ageAnti-Pertussis Toxin, anti-Filamentous Haemagglutinin and anti-pertactin immunoglobulin IgG titers, measured in blood samples taken from cord and at week 8 postpartum in all participating infants

Secondary

MeasureTime frameDescription
Titers of pertussis specific antibodies in infants before and after a fourth dose of a pertussis vaccineFrom 13 to 16 monthsAnti-Pertussis Toxin, anti-Filamentous Haemagglutinin and anti-pertactin immunoglobulin IgG titers, measured in blood samples taken before and 1 month after a fourth pertussis vaccine
Titers of pertussis specific antibodies in infants in-between the fourth and fifth dose of a pertussis vaccineAround 3 years of ageAnti-Pertussis Toxin, anti-Filamentous Haemagglutinin and anti-pertactin immunoglobulin IgG titers, measured in blood samples taken before and 1 month after a fourth pertussis vaccine
Titers of pertussis specific antibodies in infants before and after a fifth dose of a pertussis vaccineFrom 5 to 6 years of ageAnti-Pertussis Toxin, anti-Filamentous Haemagglutinin and anti-pertactin immunoglobulin IgG titers, measured in blood samples taken before and 1 month after a fourth pertussis vaccine
Titers of pertussis specific antibodies in infants after 3 doses of a pertussis vaccineAt the age of 5 monthsAnti-Pertussis Toxin, anti-Filamentous Haemagglutinin and anti-pertactin immunoglobulin IgG titers, measured in blood samples taken at 5 months (after a primary series of 3 vaccines)
Th2 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccinesFrom 8 weeks of age until 16 months of ageMeasurement of Th2 markers in a convenience sample of infants after primary and booster pertussis vaccination
Th1 & Th2 immune responses in preterm and term born infants before and after a fifth booster dose of a pertussis vaccineFrom 5 to 6 years of ageMeasurement of Th1 and Th2 markers in a convenience sample of infants before and after a pertussis booster vaccination
Titers of pertussis specific IgA antibodies in breast milkFrom birth until 3 months postpartumMeasurement of anti-Pertussis Toxin IgA, total IgA and lactoferrin titers in breast milk samples taken at birth, at week 4, 8 and 12
Th1 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccinesFrom 8 weeks of age until 16 months of ageMeasurement of Th1 markers in a convenience sample of infants after primary and booster pertussis vaccination

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 12, 2026