Immunization; InfectionNCT03519373
Pertussis Immunization During Pregnancy & HIV Infection
An observational study of Immunization; Infection and Pertussis, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
Trial summary
The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunization; Infection, Pertussis, HIV-1-infection
- What is being tested?
- TDaP
- Type of treatment
- Vaccines
- How many people
- 135 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2017to 1 Jun 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recruitment at the Pre-natal clinic for pregnant women (HIV-infected or uninfected) on voluntary basis Recruitment at the Travel \& Vaccine Clinic for HIV-uninfected non-pregnant women
Who may be able to join
- Age over 18
- HIV-infected or uninfected pregnant women in their second/third trimester with an indication of TDaP vaccination
- Non pregnant HIV negative women (having a negative HIV test in the last 6 months or at screening) with an indication of TDaP vaccination
Who cannot join
- Grade III/IV anemia
- Active bacterial infection
- Opportunistic infection (Tuberculosis, CMV, toxoplasmosis, etc)
- Inability to understand the nature and extent of the study and the procedures required
- Current or recent use of immunosuppressive drugs (corticosteroids, anti-TNF, methotrexate, etc)
- Active neoplasia
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
CHU Saint-Pierre
Brussels, 1000
HIS Etterbeek Ixelles
Ixelles-Elsene, 1050
About this study
Official title: Impact of HIV Infection and Pregnancy on Humoral Responses to Pertussis Immunization
The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.
Read the detailed description
Despite the growing importance of maternal immunization in the control of infectious pathogens in early life, the impact of pregnancy on vaccine immunogenicity remains poorly understood. Evidence suggests that pregnancy may influence the quality of the antibody response to vaccines. Pregnancy is associated with modifications in the glycosylation profile of immunoglobulins G (IgG). Different patterns of glycosylation are associated with differential regulation of the effector functions of IgG such as antibody-dependent cell cytotoxicity, complement activation or antibody dependent phagocytosis. Whether similar modifications affect vaccine-induced IgG in pregnant women is unknown.
HIV infection is associated with important alterations in B cells and antibodies. Although antiretroviral therapy partly corrects the proportions of memory B cells (MBC) subsets, it does not restore B cell responses to vaccines, measured as seroconversion rates and antibody persistence. Reduced IgG responses to vaccines have been observed in HIV-infected pregnant women but the impact of HIV on the quality of vaccine-induced IgG has not been reported. On the other hand, HIV infection in pregnancy has a strong impact on the transfer of maternal IgG to the newborn, possibly as a consequence of hypergammaglobulinemia and immune activation.
The investigators will:
- Assess the respective impact of pregnancy and HIV infection on the magnitude and quality of B cell and antibody responses to pertussis immunization with the TDaP vaccine.
- Assess the impact of HIV infection and of the timing of maternal immunization on the transplacental transfer and on the quality of pertussis-specific IgG in the newborn.
- Conditions
- Immunization; Infection, Pertussis, HIV-1-infection, Pregnancy
- Being tested
- TDaP
- Medical subject headings
- Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDaPBiological
Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)
| Study group | Role | What they receive |
|---|---|---|
| PER001 | HIV 1-infected pregnant women Receives: Biological: TDaP | |
| PER002 | HIV 1-uninfected pregnant women Receives: Biological: TDaP | |
| PER003 | HIV 1-uninfected non-pregnant women Receives: Biological: TDaP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pertussis-specific antibodies GMC after immunization
Anti-Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and pertactin (PRN) specific antibodies levels
Measured: 7-10 days, 30 days and at delivery for pregnant women
Transplacental transfer of pertussis-specific antibodies
Anti-PT, FHA and PRN specific antibodies levels transfer ratio
Measured: Birth
Secondary outcomes (2)
Pertussis-specific memory B cells quantification & phenotype
PT, FHA and PRN-specific memory B cells numbers assessed by ELISPOT assay \& Flow Cytometry
Measured: 7-10 days, 30 days and at delivery for pregnant women
Pertussis-specific antibodies glycosylation profiles
Anti-PT, FHA and PRN specific antibodies profiles
Measured: 7-10 days, 30 days and at delivery for pregnant women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Mar 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunization; InfectionStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Dauby, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Nicolas Dauby, M.D. Ph.D., Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519373
- Sponsor's protocol ID
- Pertussis
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taton M, Willems F, Widomski C, Martin C, Jiang Y, Renard K, Cogan A, Necsoi C, Ackerman ME, Marchant A, Dauby N. Impact of pregnancy on polyfunctional IgG and memory B cell responses to Tdap immunization. Vaccine. 2023 Jun 19;41(27):4009-4018. doi: 10.1016/j.vaccine.2023.05.035. Epub 2023 May 25.
PubMed 37244810
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HIV Infection and Pregnancy on Humoral Responses to Pertussis Immunization
- ClinicalTrials.gov ID
- NCT03519373
- Acronym / sponsor ID
- Pertussis
- Conditions
- Immunization; Infection, Pertussis, HIV-1-infection, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 May 2018 (actual)
- 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.
The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.
Detailed description
Despite the growing importance of maternal immunization in the control of infectious pathogens in early life, the impact of pregnancy on vaccine immunogenicity remains poorly understood. Evidence suggests that pregnancy may influence the quality of the antibody response to vaccines. Pregnancy is associated with modifications in the glycosylation profile of immunoglobulins G (IgG). Different patterns of glycosylation are associated with differential regulation of the effector functions of IgG such as antibody-dependent cell cytotoxicity, complement activation or antibody dependent phagocytosis. Whether similar modifications affect vaccine-induced IgG in pregnant women is unknown.
HIV infection is associated with important alterations in B cells and antibodies. Although antiretroviral therapy partly corrects the proportions of memory B cells (MBC) subsets, it does not restore B cell responses to vaccines, measured as seroconversion rates and antibody persistence. Reduced IgG responses to vaccines have been observed in HIV-infected pregnant women but the impact of HIV on the quality of vaccine-induced IgG has not been reported. On the other hand, HIV infection in pregnancy has a strong impact on the transfer of maternal IgG to the newborn, possibly as a consequence of hypergammaglobulinemia and immune activation.
The investigators will:
- Assess the respective impact of pregnancy and HIV infection on the magnitude and quality of B cell and antibody responses to pertussis immunization with the TDaP vaccine.
- Assess the impact of HIV infection and of the timing of maternal immunization on the transplacental transfer and on the quality of pertussis-specific IgG in the newborn.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PER001 | – | Biological: TDaPHIV 1-infected pregnant women |
| PER002 | – | Biological: TDaPHIV 1-uninfected pregnant women |
| PER003 | – | Biological: TDaPHIV 1-uninfected non-pregnant women |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitment at the Pre-natal clinic for pregnant women (HIV-infected or uninfected) on voluntary basis Recruitment at the Travel \& Vaccine Clinic for HIV-uninfected non-pregnant women
Key inclusion criteria (3 listed)
- Age over 18
- HIV-infected or uninfected pregnant women in their second/third trimester with an indication of TDaP vaccination
- Non pregnant HIV negative women (having a negative HIV test in the last 6 months or at screening) with an indication of TDaP vaccination
Key exclusion criteria (6 listed)
- Grade III/IV anemia
- Active bacterial infection
- Opportunistic infection (Tuberculosis, CMV, toxoplasmosis, etc)
- Inability to understand the nature and extent of the study and the procedures required
- Current or recent use of immunosuppressive drugs (corticosteroids, anti-TNF, methotrexate, etc)
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 |
|---|---|---|
| TDaPTetanus, Diphteria and Acellular Pertussis vaccine (Boostrix) | Biological | PER001, PER002, PER003 |
Primary outcome
Pertussis-specific antibodies GMC after immunization
Time frame: 7-10 days, 30 days and at delivery for pregnant women
Anti-Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and pertactin (PRN) specific antibodies levels
Transplacental transfer of pertussis-specific antibodies
Time frame: Birth
Anti-PT, FHA and PRN specific antibodies levels transfer ratio
2 secondary outcomes
Pertussis-specific memory B cells quantification & phenotype
Time frame: 7-10 days, 30 days and at delivery for pregnant women
Pertussis-specific antibodies glycosylation profiles
Time frame: 7-10 days, 30 days and at delivery for pregnant women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 37244810Taton M, Willems F, Widomski C, Martin C, Jiang Y, Renard K, Cogan A, Necsoi C, Ackerman ME, Marchant A, Dauby N. Impact of pregnancy on polyfunctional IgG and memory B cell responses to Tdap immunization. Vaccine. 2023 Jun 19;41(27):4009-4018. doi: 10.1016/j.vaccine.2023.05.035. Epub 2023 May 25.
- Individual participant dataSharing planned: Undecided
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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.
Nicolas Dauby, M.D. Ph.D. principal investigator
Centre Hospitalier Universitaire Saint Pierre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunization; Infection and Pertussis, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pertussis-specific antibodies GMC after immunization (time frame: 7-10 days, 30 days and at delivery for pregnant women). The study lists 2 primary outcomes in all. 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 NCT03519373, which also lists 1 linked publication.
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 3 Dec 2024.