Maternal Pertussis Wholecell Responses

Summary

Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants \<3 months old, before possible prevention via the infant immunization programme1. To protect these most vulnerable infants, the World Health Organisation (WHO) recommends Tdap vaccination as safe in pregnancy and recommends the use of wP vaccines within the EPI. Maternal antibody following aP vaccination can interfere with infant anti-pertussis antibody responses post infant EPI vaccination, which is of concern in high burden settings such as Uganda. There are therefore multiple factors in this population which may influence the effect of pertussis immunization in pregnancy, and which have not been studied, most notably HIV infection and interference with wP vaccines in infants. The immunogenicity of Tdap in HIV-infected pregnant women has not yet been examined. In addition, to date, the effect of maternal vaccination, placental transfer and infant antibody responses in HEU infants have not been studied at all. There are no studies examining the immune response to wP vaccine administered to infants (EPI recommendation) whose mothers received aP in pregnancy.

Conditions

• Pertussis

Interventions

BIOLOGICAL

Standard of care vaccines

Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance)

BIOLOGICAL

Boostagen, (BioNet-Asia)

Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance);

Sponsors & Collaborators

• Medical Research Council

  collaborator OTHER_GOV

• University of British Columbia

  collaborator OTHER

• Public Health England

  collaborator OTHER_GOV

• MU-JHU CARE

  collaborator OTHER

• BioNet-Asia

  collaborator UNKNOWN

• St George's, University of London

  lead OTHER

Principal Investigators

• Kirsty Le Doare, MBBS, PhD · St George's, University of London

• Manish Sadarangani, MRCPCH, DPHIL, BM.BCh, MA · BC Children's Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-21

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Uganda

Study Locations