Optimising the Timing of Whooping Cough Immunisation in MUMs

NCT03908164 | Unknown Phase 4

• 1 other identifier: 2018.0297
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Immunization; Infection; Pertussis

Keywords

Pregnancy; Immunisation; Pertussis

Outcome Measures

Primary Outcomes (1)

• Pertussis specific antibody concentration in cord blood of term infants

  Antibody concentrations against Pertussis Toxin (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) from cord blood of term infants. This will be measured using ELISA.

  Delivery of infant

Secondary Outcomes (5)

• Pertussis specific antibody concentration in cord blood of preterm infants

  Delivery of infant

• Kinetics of antibody response to pertussis vaccination during pregnancy

  Prior to vaccination, 14 days following vaccination, delivery

• Placental transfer of antibody

  Time of delivery

• Impact of repeated vaccination on antibody response in women who have received a pertussis vaccination in a previous pregnancy

  Prior to vaccination, 14 days following vaccination and at delivery

• Antibody concentration in infants following primary immunisation schedule

  28-42 days following completion of primary immunisations

Other Outcomes (1)

• Functional assays on serum

  Samples collected following vaccination, from the cord blood at delivery and in the infants following primary vaccination.

Study Arms (3)

Vaccination at <23+6 gestational weeks

EXPERIMENTAL

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

Vaccination at 24-27+6 gestational weeks

EXPERIMENTAL

Participants will receive a pertussis containing vaccine licensed for use in pregnancy between 24 and 27+6 gestational weeks.

Biological: Pertussis containing vaccine

Vaccination at 28-31+6 gestational weeks

EXPERIMENTAL

Participants will receive a pertussis containing vaccine licensed for use in pregnancy between 28 and 31+6 gestational weeks.

Biological: Pertussis containing vaccine

Interventions

Pertussis containing vaccine BIOLOGICAL

Participants will receive a pertussis containing vaccine licensed for use in pregnancy at one of three time periods.

Vaccination at 24-27+6 gestational weeks; Vaccination at 28-31+6 gestational weeks; Vaccination at <23+6 gestational weeks

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• Thrasher Research Fund: collaborator
• Department of Health, United Kingdom: collaborator

Study Sites (1)

St Georges University Hospital NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Calvert A, Amirthalingam G, Andrews N, Basude S, Coleman M, Cuthbertson H, England A, Greening V, Hallis B, Johnstone E, Jones CE, Karampatsas K, Khalil A, Le Doare K, Matheson M, Peregrine E, Snape MD, Vatish M, Heath PT; OpTIMUM Study Group. Optimising the timing of whooping cough immunisation in mums (OpTIMUM) through investigating pertussis vaccination in pregnancy: an open-label, equivalence, randomised controlled trial. Lancet Microbe. 2023 May;4(5):e300-e308. doi: 10.1016/S2666-5247(22)00332-9. Epub 2023 Apr 17.

  PMID: 37080224 DERIVED

MeSH Terms

Conditions

Infections; Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Paul Heath

  St George's, University of London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: April 9, 2019
• Study Start: May 7, 2019
• Primary Completion: December 10, 2020
• Study Completion: May 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)