Gambia Pertussis Study (GaPs)

Summary

Currently, there are two types of vaccines available against pertussis (whooping cough), an infectious disease of the respiratory tract that can be extremely serious in very young children.

Both have advantages and disadvantages: The acellular form (aP, mainly used in resource-rich countries) does not appear to offer as long lasting protection, but the whole cell vaccine (wP, mainly used in LMIC) appears to be generally more reactogenic. There is consensus that a "better pertussis vaccine" ought to be designed.

The GaPs trial is part of a series of clinical trials performed by the PERtussIS COrrelates of Protection Europe (PERISCOPE) Consortium, an EU-funded group of investigators which aims to generate knowledge on immune responses to pertussis. A better understanding of human biomarkers of protective immune responses to B. pertussis and its waning immunity is needed to accelerate the design and testing of new pertussis vaccines with a longer duration of protection.

This proposal describes the design and objectives of the clinical trial to be conducted in the Gambia, which is the only site in Africa involved in the consortium and involves the recruitment of 600 mother/infant pairs. Pregnant women will be randomised to receive either the usually recommended tetanus vaccination or a combination vaccine against whooping cough, diptheria, tetanus and polio. Their infants will receive either aP or wP as part of their EPI vaccines, and resulting immune responses will be characterized in detail up to the age of 9 months. The investigators will use immunological assays to investigate the functional humoral and cellular responses to pertussis in infants born to mothers who are randomized to receiving pertussis vaccine in pregnancy or not, and their infants who will receive either aP or wP vaccine.

Our research questions are:

Does vaccination against pertussis in pregnancy have impact on subsequent immune responses to pertussis vaccine and other EPI vaccines in the infants Does vaccination of infants with wP vaccine induce different levels and functionality of antibody and/or T cell responses than vaccination with aP vaccine What is the difference in innate and acquired immunity- as measured with novel systems vaccinology tools- between being vaccinated with wP versus aP?

Conditions

• Pertussis

Interventions

BIOLOGICAL

Boostrix IPV infant acellular Pertussis

mother is randomized to receive Boostrix ® Polio (GSK) and infant acellular pertussis

BIOLOGICAL

Boostrix IPV infant whole Pertussis

mother is randomized to receive Boostrix ® Polio (GSK) and infant whole Pertussis

BIOLOGICAL

TT infant acellular Pertussis

mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis

BIOLOGICAL

TT infant whole Pertussis

mother is randomised to receive Tetanus Toxoid and infant whole Pertussis

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• National Institute for Public Health and the Environment (RIVM)

  collaborator OTHER_GOV

• Radboud University Medical Center

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Turku

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Beate Kampmann, MD, PhD · MRC Unit at LSHTM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-23

Primary Completion

2022-05-18

Completion

2022-12-31

Countries

• The Gambia