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Optimising the Timing of Whooping Cough Immunisation in MUMs (OpTIMUM)

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ClinicalTrials.gov Identifier: NCT03908164
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
Thrasher Research Fund
Department of Health, United Kingdom
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
A multicentre study to evaluate the impact of timing of whooping cough (pertussis) vaccination in pregnancy, with participants randomised to receive whooping cough vaccination at one of three time points in pregnancy.

Condition or disease Intervention/treatment Phase
Pregnancy Related Immunization; Infection Pertussis Biological: Pertussis containing vaccine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimising the Timing of Whooping Cough Immunisation in MUMs
Estimated Study Start Date : April 12, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccination at <23+6 gestational weeks
Participants will receive a pertussis containing vaccine licensed for use in pregnancy before 23+6 gestational weeks (GW). Although the time period for study group 1 is ≤23+6 no pertussis vaccine will be given in this study at less than 16 GW.
Biological: Pertussis containing vaccine
Participants will receive a pertussis containing vaccine licensed for use in pregnancy at one of three time periods.

Experimental: Vaccination at 24-27+6 gestational weeks
Participants will receive a pertussis containing vaccine licensed for use in pregnancy between 24 and 27+6 gestational weeks.
Biological: Pertussis containing vaccine
Participants will receive a pertussis containing vaccine licensed for use in pregnancy at one of three time periods.

Experimental: Vaccination at 28-31+6 gestational weeks
Participants will receive a pertussis containing vaccine licensed for use in pregnancy between 28 and 31+6 gestational weeks.
Biological: Pertussis containing vaccine
Participants will receive a pertussis containing vaccine licensed for use in pregnancy at one of three time periods.




Primary Outcome Measures :
  1. Pertussis specific antibody concentration in cord blood of term infants [ Time Frame: Delivery of infant ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) from cord blood of term infants. This will be measured using ELISA.


Secondary Outcome Measures :
  1. Pertussis specific antibody concentration in cord blood of preterm infants [ Time Frame: Delivery of infant ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) from cord blood of preterm infants. This will be measured using ELISA.

  2. Kinetics of antibody response to pertussis vaccination during pregnancy [ Time Frame: Prior to vaccination, 14 days following vaccination, delivery ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) in maternal blood prior to vaccination, 14 days following vaccination and at delivery. This will be measured using ELISA.

  3. Placental transfer of antibody [ Time Frame: Time of delivery ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) in maternal and cord blood at time of delivery. This will be measured using ELISA.

  4. Impact of repeated vaccination on antibody response in women who have received a pertussis vaccination in a previous pregnancy [ Time Frame: Prior to vaccination, 14 days following vaccination and at delivery ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) in maternal blood prior to vaccination, 14 days following vaccination and at delivery. This will be measured using ELISA.

  5. Antibody concentration in infants following primary immunisation schedule [ Time Frame: 28-42 days following completion of primary immunisations ]
    Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) from the infant following primary immunisations. This will be measured using ELISA.


Other Outcome Measures:
  1. Functional assays on serum [ Time Frame: Samples collected following vaccination, from the cord blood at delivery and in the infants following primary vaccination. ]
    Serum bactericidal assays will be performed. The bactericidal titre is the last serum dilution where ≥50% killing is observed compared to complement only control. Serum bactericidal assays will be performed and the bactericidal titre will be compared according to the time of vaccination.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant and not yet having received pertussis vaccination
  • Willing and able to comply with study procedures and provide informed consent
  • Documentation of a 20-week anomaly scan with no life limiting congenital anomalies identified

Exclusion Criteria:

  • Age less than 16 years
  • Confirmed or suspected pertussis in previous five years
  • Known diagnosis of immune deficiency
  • Receiving immunosuppressive medication within six months of enrolment in the study (this does not include inhaled or topical steroids)
  • In the opinion of the investigator is unlikely to complete follow up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908164


Contacts
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Contact: Jennifer Stuart 02087255382 jstuart@sgul.ac.uk
Contact: Anna Calvert, MBChB 02087253887 acalvert@sgul.ac.uk

Locations
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United Kingdom
St Georges University Hospital NHS Foundation Trust
Tooting, London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London
Thrasher Research Fund
Department of Health, United Kingdom
Investigators
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Study Chair: Paul Heath St George's, University of London

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03908164     History of Changes
Other Study ID Numbers: 2018.0297
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St George's, University of London:
Pregnancy
Immunisation
Pertussis

Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs