PertussisMAMANCT02511327
Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants
An observational study of Pertussis, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Infant pertussis vaccination
- Type of treatment
- Vaccines
- How many people
- 232 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Four cohorts of women-infant pairs will be recruited before or directly after delivery. A cohort of preterm born infants will be compared to term born infants, and both will be compared within groups of vaccinated women (adult acellular pertussis containing vaccine) or unvaccinated women.
Who may be able to join
- 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
Who cannot join
- 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
- No signed informed consent from both parents
Show all 11Show fewer
- Severe reactions to any vaccine
- Serious underlying medical condition (e.g., genetic disorder (eg Down syndrome), immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, lung/heart disease, liver/kidney disease, chronic or recurrent infections)
- Children suffering from primary humoral immune disorders (B cell related): severe X linked agammaglobulinaemia, CVID (Common variable immunodeficiency, late onset agammaglobulnaemia) and SAD (specific antibody deficiency); suffering from primary cellular immune deficiencies (T cell related): SCID (Severe combined immune deficiency syndrome), CID, hyper IGM syndrome, di George's syndrome and others; suffering from disorders in phagocytosis and chemotaxis (CGD, Schwach Diamond syndrome) and disorders from the complement cascade
- In addition children with oncologic disorders will be excluded. All these children can receive the inactivated pertussis vaccines, but will respond different from the normal population to vaccination.
- Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pertussis Immunization During Pregnancy: Assessment of the Role of Maternal Antibodies on Immune Responses in Term and Preterm Infants: the MAMA Study
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.
- Conditions
- Pertussis
- Being tested
- Infant pertussis vaccination
- Keywords
- Pertussis, Pregnancy, Vaccination, Preterm, Breast milk, Humoral immune response, Cellular immune response, Maternal antibodies
- Medical subject headings
- Whooping Cough, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant pertussis vaccinationDrug
Also called Infant pertussis containing vaccination
Infants receive pertussis vaccines according to the national recommended schedule
| Study group | Role | What they receive |
|---|---|---|
| Preterm born infants of vaccinated women | Preterm born infants (< 37 weeks of gestation) whose mothers have received an acellular pertussis vaccine during pregnancy, within the national recommended vaccination programme. Infant vaccination against pertussis is performed according to the national recommended schedule. Receives: Drug: Infant pertussis vaccination | |
| Term born infants vaccinated women | Term born infants (>= 37 weeks of gestation) whose mothers have received an acellular pertussis vaccine during pregnancy, within the national recommended vaccination programme. Infant vaccination against pertussis is performed according to the national recommended schedule. Receives: Drug: Infant pertussis vaccination | |
| Term born infants unvaccinated women | Term born infants (>= 37 weeks of gestation) whose mothers have not received an acellular pertussis vaccine during pregnancy. Infant vaccination against pertussis is performed according to the national recommended schedule. Receives: Drug: Infant pertussis vaccination | |
| Preterm born infants unvaccinated women | Preterm born infants (< 37 weeks of gestation) whose mothers have not received an acellular pertussis vaccine during pregnancy.Infant vaccination against pertussis is performed according to the national recommended schedule. Receives: Drug: Infant pertussis vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of maternal pertussis specific antibodies
Anti-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
Measured: From birth until 8 weeks of age
Secondary outcomes (8)
Titers of pertussis specific antibodies in infants after 3 doses of a pertussis vaccine
Anti-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)
Measured: At the age of 5 months
Titers of pertussis specific antibodies in infants before and after a fourth dose of a pertussis vaccine
Anti-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
Measured: From 13 to 16 months
Titers of pertussis specific antibodies in infants in-between the fourth and fifth dose of a pertussis vaccine
Anti-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
Measured: Around 3 years of age
Titers of pertussis specific antibodies in infants before and after a fifth dose of a pertussis vaccine
Anti-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
Measured: From 5 to 6 years of age
Th1 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccines
Measurement of Th1 markers in a convenience sample of infants after primary and booster pertussis vaccination
Measured: From 8 weeks of age until 16 months of age
Th2 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccines
Measurement of Th2 markers in a convenience sample of infants after primary and booster pertussis vaccination
Measured: From 8 weeks of age until 16 months of age
Th1 & Th2 immune responses in preterm and term born infants before and after a fifth booster dose of a pertussis vaccine
Measurement of Th1 and Th2 markers in a convenience sample of infants before and after a pertussis booster vaccination
Measured: From 5 to 6 years of age
Titers of pertussis specific IgA antibodies in breast milk
Measurement of anti-Pertussis Toxin IgA, total IgA and lactoferrin titers in breast milk samples taken at birth, at week 4, 8 and 12
Measured: From birth until 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Université Libre de Bruxelles, Research Foundation Flanders
- Responsible party
- Principal investigator, Elke Leuridan, MD, PhD, Universiteit Antwerpen
- Investigators
- Elke Leuridan, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511327
- Sponsor's protocol ID
- cev003
- Acronym
- MAMA
- Status last verified
- Jan 2021
- First submitted
- 22 Jul 2015
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Embacher S, Maertens K, Herzog SA. Half-life Estimation of Pertussis-Specific Maternal Antibodies in (Pre)Term Infants After In-Pregnancy Tetanus, Diphtheria, Acellular Pertussis Vaccination. J Infect Dis. 2023 Nov 28;228(11):1640-1648. doi: 10.1093/infdis/jiad212.
PubMed 37285482Maertens K, Orije MRP, Huoi C, Boisnard F, Lyabis O. Immunogenicity of a liquid hexavalent DTaP-IPV-HB-PRP approximately T vaccine after primary and booster vaccination of term and preterm infants born to women vaccinated with Tdap during pregnancy. Vaccine. 2023 Jan 16;41(3):795-804. doi: 10.1016/j.vaccine.2022.12.021. Epub 2022 Dec 15.
PubMed 36528443Orije MRP, Garcia-Fogeda I, Van Dyck W, Corbiere V, Mascart F, Mahieu L, Hens N, Van Damme P, Cools N, Ogunjimi B, Maertens K, Leuridan E. Impact of Maternal Pertussis Antibodies on the Infants' Cellular Immune Responses. Clin Infect Dis. 2022 Aug 31;75(3):442-452. doi: 10.1093/cid/ciab972.
PubMed 34849638Maertens K, Orije MRP, Herzog SA, Mahieu LM, Hens N, Van Damme P, Leuridan E. Pertussis Immunization During Pregnancy: Assessment of the Role of Maternal Antibodies on Immune Responses in Term and Preterm-Born Infants. Clin Infect Dis. 2022 Jan 29;74(2):189-198. doi: 10.1093/cid/ciab424.
PubMed 33971009Orije MRP, Lariviere Y, Herzog SA, Mahieu LM, Van Damme P, Leuridan E, Maertens K. Breast Milk Antibody Levels in Tdap-Vaccinated Women After Preterm Delivery. Clin Infect Dis. 2021 Sep 15;73(6):e1305-e1313. doi: 10.1093/cid/ciab260.
PubMed 33768227
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertussis Immunization During Pregnancy: Assessment of the Role of Maternal Antibodies on Immune Responses in Term and Preterm Infants: the MAMA Study
- ClinicalTrials.gov ID
- NCT02511327
- Acronym / sponsor ID
- MAMA / cev003
- Conditions
- Pertussis
- Keywords
- Pertussis, Pregnancy, Vaccination, Preterm, Breast milk, Humoral immune response, Cellular immune response, Maternal antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Université Libre de Bruxelles, Research Foundation Flanders
- Study start
- Jan 2015
- Primary completion
- Jan 2019 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm born infants of vaccinated women | – | Drug: Infant pertussis vaccinationPreterm born infants (< 37 weeks of gestation) whose mothers have received an acellular pertussis vaccine during pregnancy, within the national recommended vaccination programme. Infant vaccination against pertussis is performed according to the national recommended schedule. |
| Term born infants vaccinated women | – | Drug: Infant pertussis vaccinationTerm born infants (>= 37 weeks of gestation) whose mothers have received an acellular pertussis vaccine during pregnancy, within the national recommended vaccination programme. Infant vaccination against pertussis is performed according to the national recommended schedule. |
| Term born infants unvaccinated women | – | Drug: Infant pertussis vaccinationTerm born infants (>= 37 weeks of gestation) whose mothers have not received an acellular pertussis vaccine during pregnancy. Infant vaccination against pertussis is performed according to the national recommended schedule. |
| Preterm born infants unvaccinated women | – | Drug: Infant pertussis vaccinationPreterm born infants (< 37 weeks of gestation) whose mothers have not received an acellular pertussis vaccine during pregnancy.Infant vaccination against pertussis is performed according to the national recommended schedule. |
Who may qualify
- Ages
- 0 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Four cohorts of women-infant pairs will be recruited before or directly after delivery. A cohort of preterm born infants will be compared to term born infants, and both will be compared within groups of vaccinated women (adult acellular pertussis containing vaccine) or unvaccinated women.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant pertussis vaccinationAlso: Infant pertussis containing vaccinationInfants receive pertussis vaccines according to the national recommended schedule | Drug | Preterm born infants of vaccinated women, Preterm born infants unvaccinated women, Term born infants unvaccinated women, Term born infants vaccinated women |
Primary outcome
Titers of maternal pertussis specific antibodies
Time frame: From birth until 8 weeks of age
Anti-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
8 secondary outcomes
Titers of pertussis specific antibodies in infants after 3 doses of a pertussis vaccine
Time frame: At the age of 5 months
Titers of pertussis specific antibodies in infants before and after a fourth dose of a pertussis vaccine
Time frame: From 13 to 16 months
Titers of pertussis specific antibodies in infants in-between the fourth and fifth dose of a pertussis vaccine
Time frame: Around 3 years of age
Titers of pertussis specific antibodies in infants before and after a fifth dose of a pertussis vaccine
Time frame: From 5 to 6 years of age
Th1 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccines
Time frame: From 8 weeks of age until 16 months of age
Th2 immune responses in preterm and term born infants before and after a primary series of infant pertussis vaccines
Time frame: From 8 weeks of age until 16 months of age
Th1 & Th2 immune responses in preterm and term born infants before and after a fifth booster dose of a pertussis vaccine
Time frame: From 5 to 6 years of age
Titers of pertussis specific IgA antibodies in breast milk
Time frame: From birth until 3 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Derived from this study: PubMed 37285482Embacher S, Maertens K, Herzog SA. Half-life Estimation of Pertussis-Specific Maternal Antibodies in (Pre)Term Infants After In-Pregnancy Tetanus, Diphtheria, Acellular Pertussis Vaccination. J Infect Dis. 2023 Nov 28;228(11):1640-1648. doi: 10.1093/infdis/jiad212.
- Derived from this study: PubMed 36528443Maertens K, Orije MRP, Huoi C, Boisnard F, Lyabis O. Immunogenicity of a liquid hexavalent DTaP-IPV-HB-PRP approximately T vaccine after primary and booster vaccination of term and preterm infants born to women vaccinated with Tdap during pregnancy. Vaccine. 2023 Jan 16;41(3):795-804. doi: 10.1016/j.vaccine.2022.12.021. Epub 2022 Dec 15.
- Derived from this study: PubMed 34849638Orije MRP, Garcia-Fogeda I, Van Dyck W, Corbiere V, Mascart F, Mahieu L, Hens N, Van Damme P, Cools N, Ogunjimi B, Maertens K, Leuridan E. Impact of Maternal Pertussis Antibodies on the Infants' Cellular Immune Responses. Clin Infect Dis. 2022 Aug 31;75(3):442-452. doi: 10.1093/cid/ciab972.
- Derived from this study: PubMed 33971009Maertens K, Orije MRP, Herzog SA, Mahieu LM, Hens N, Van Damme P, Leuridan E. Pertussis Immunization During Pregnancy: Assessment of the Role of Maternal Antibodies on Immune Responses in Term and Preterm-Born Infants. Clin Infect Dis. 2022 Jan 29;74(2):189-198. doi: 10.1093/cid/ciab424.
- Derived from this study: PubMed 33768227Orije MRP, Lariviere Y, Herzog SA, Mahieu LM, Van Damme P, Leuridan E, Maertens K. Breast Milk Antibody Levels in Tdap-Vaccinated Women After Preterm Delivery. Clin Infect Dis. 2021 Sep 15;73(6):e1305-e1313. doi: 10.1093/cid/ciab260.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elke Leuridan, MD, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titers of maternal pertussis specific antibodies (time frame: From birth until 8 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511327, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.