NCT03519373

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

April 26, 2018

Last Update Submit

November 29, 2024

Conditions

Immunization; InfectionPertussisHIV-1-infectionPregnancy

Outcome Measures

Primary Outcomes (2)

  • Pertussis-specific antibodies GMC after immunization

    Anti-Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and pertactin (PRN) specific antibodies levels

    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

    Birth

Secondary Outcomes (2)

  • Pertussis-specific memory B cells quantification & phenotype

    7-10 days, 30 days and at delivery for pregnant women

  • Pertussis-specific antibodies glycosylation profiles

    7-10 days, 30 days and at delivery for pregnant women

Study Arms (3)

PER001

HIV 1-infected pregnant women

Biological: TDaP

PER002

HIV 1-uninfected pregnant women

Biological: TDaP

PER003

HIV 1-uninfected non-pregnant women

Biological: TDaP

Interventions

TDaPBIOLOGICAL

Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)

PER001PER002PER003

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

HIS Etterbeek Ixelles

Ixelles-Elsene, 1050, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 37244810DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* PBMCs * Serum

MeSH Terms

Conditions

InfectionsWhooping Cough

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Nicolas Dauby, M.D. Ph.D.

    Centre Hospitalier Universitaire Saint Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Ph.D.

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 9, 2018

Study Start

March 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

BE(2)