Gambia Pertussis Study (GaPs)

NCT03606096 | Unknown Phase 4 DMC

• 1 other identifier: SCC 1600
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immune response; impact of acellular pertussis vaccination

Outcome Measures

Primary Outcomes (2)

• PT specific antibody GMC

  PT-specific antibody GMC at 20 weeks in infants vaccinated with aP versus wP

  20 weeks

• PT specific antibody GMC

  PT-specific antibody GMC at 9 months in infants vaccinated with aP versus wP

  9 months

Secondary Outcomes (9)

• PT specific antibody

  at 20 weeks and 9 months

• change in PT, FHA, and PRN antibody concentrations

  at 8 and 20 weeks and at 9 months of age

• Pertussis antigen-specific memory B-cell

  at 8, 16 weeks and at 9 months of age

• Pertussis antigen-specific Th1, Th2 and Th17 responses

  at 16 weeks of age of the infant

• PT, FHA and PRN-specific antibody GMC and GMR

  at baseline (cord blood baseline) and at 8, 20 weeks and at 9 months

Study Arms (4)

Boostrix IPV - infant acellular Pertussis (TdaP-aP)

EXPERIMENTAL

vaccination of the mother with Boostrix-IPV vaccine which includes the infant acellular pertussis

Biological: Boostrix IPV infant acellular Pertussis

Boostrix IPV - infant whole Pertussis (Tdap-wP )

EXPERIMENTAL

vaccination of mother with Boostrix -IPV which includes infant whole cell pertussis

Biological: Boostrix IPV infant whole Pertussis

TT - infant acellular Pertussis (T-ap )

ACTIVE COMPARATOR

vaccination of mother with TT-which includes infant acellular pertussis

Biological: TT infant acellular Pertussis

TT - infant whole Pertussis (T-wP)

ACTIVE COMPARATOR

vaccination of mother with T which includes infant whole cell pertussis

Biological: TT infant whole Pertussis

Interventions

Boostrix IPV infant acellular Pertussis BIOLOGICAL

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

Boostrix IPV - infant acellular Pertussis (TdaP-aP)

Boostrix IPV infant whole Pertussis BIOLOGICAL

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

Boostrix IPV - infant whole Pertussis (Tdap-wP )

TT infant acellular Pertussis BIOLOGICAL

mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis

TT - infant acellular Pertussis (T-ap )

TT infant whole Pertussis BIOLOGICAL

mother is randomised to receive Tetanus Toxoid and infant whole Pertussis

TT - infant whole Pertussis (T-wP)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: The study will randomize 600 pregnant women at between 28-34 weeks gestation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• signed /thumb-printed informed consent for trial participation obtained
• Pregnant women between 18 and 40 years of age inclusive on day of consent
• Singleton pregnancy
• From 28 to 34 weeks gestation inclusive as determined by USS on day of randomization.
• Resident within easy reach of the clinical trial site (no fixed boundaries will be set and such judgements will be made on a case by case basis by members of the field team in discussion with the potential participant, taking into account knowledge of the local transport links and geography)
• Intention to deliver at the health centre related to the Sukuta clinical trial site
• Willingness and capacity to comply with all the study procedures, including those relating to the newborn infant, in the opinion of the principal investigator or delegee.

You may not qualify if:

• History of pre-eclampsia or eclampsia
• Gestational diabetes in current pregnancy
• Rhesus negative multigravida
• Grandmultigravida (more than 5 previous pregnancies)
• Previous late stillbirth (defined as loss of pregnancy at any time after 28 weeks gestation)
• Previous low birth weight baby or premature delivery (defined as a delivery before 37 weeks gestation)
• Previous neonatal death (defined as death of an infant within the first 28 days of life)
• Previous delivery of an infant with a known or suspected genetic or chromosomal abnormality
• History of other significant pregnancy related complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected
• History of other significant neonatal complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected
• Smoke cigarettes, alcohol consumption or use of illegal drugs during current pregnancy
• Significant maternal chronic illness including but not limited to hypertension requiring treatment, heart disease, lung disease, neurological disorders including a history of epilepsy or recurrent afebrile seizures, kidney disease, liver disease, anaemia and other haematological disorders (including sickle cell), endocrine disorders including known diabetes mellitus, autoimmunity
• Severe anaemia (less than 7.0g/dL)
• Known Human Immunodeficiency Virus (HIV) or hepatitis B (HBV) virus positive or found to be HIV or HBV positive during screening
• Positive result for syphilis infection on laboratory testing

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Oxford: collaborator
• National Institute for Public Health and the Environment (RIVM): collaborator
• Radboud University Medical Center: collaborator
• Imperial College London: collaborator
• University of Turku: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Sukuta Health Centre

Sukuta, City of Banjul, The Gambia

Location

Related Publications (3)

• Saso A, Froberg J, Jobe H, Eleveld M, Okoye M, Kanteh E, Arns A, van Opzeeland F, Kumado M, Faal A, Roberts E, Fofana ML, Baldeh AK, Conteh K, van Cranenbroek B, Roetynck S, de Jonge M, de Silva TI, Huynen M, Kampmann B, Diavatopoulos DA; GaPs Study Team. Mucosal immune responses to Bordetella pertussis in Gambian infants after maternal and primary vaccination: an immunological substudy of a single-centre, randomised, controlled, double-blind, phase 4 trial. Lancet Microbe. 2026 Aug 21:101219. doi: 10.1016/j.lanmic.2025.101219. Online ahead of print.

  PMID: 41519134 DERIVED

• Saso A, Kanteh E, Jeffries D, Okoye M, Mohammed N, Kumado M, Roetynck S, Jobe H, Faal A, Roberts E, Gageldonk P, Buisman AM, Froberg J, Cavell B, Lesne E, Barkoff AM, He Q, Tanha K, Bibi S, Kelly D, Diavatopoulos D, Kampmann B; Gambian Pertussis Study Team; members of the PERISCOPE consortium. The effect of pertussis vaccination in pregnancy on the immunogenicity of acellular or whole-cell pertussis vaccination in Gambian infants (GaPS): a single-centre, randomised, controlled, double-blind, phase 4 trial. Lancet Infect Dis. 2025 Aug;25(8):909-924. doi: 10.1016/S1473-3099(25)00072-6. Epub 2025 Mar 25.

  PMID: 40154521 DERIVED

• Saso A, Kampmann B. What Is the Impact of Maternal Pertussis Immunization in Pregnancy on the Quantity, Quality and Longevity of Infant Vaccine Responses?: A Review of the Current Evidence. Pediatr Infect Dis J. 2025 Feb 1;44(2S):S49-S55. doi: 10.1097/INF.0000000000004692. Epub 2025 Feb 14.

  PMID: 39951075 DERIVED

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• Beate Kampmann, MD, PhD

  MRC Unit at LSHTM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the expectant mothers themselves nor members of the clinical trial team assessing the safety or laboratory-based endpoints (immunogenicity and exploratory immunology) will be aware which of these groups the expectant mother has been randomized into.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible pregnant women will be randomized in parallel into one of four groups: two groups will receive maternal Boostrix ® Polio (GSK) the other two groups Tetanus toxoid as per EPI schedule.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 30, 2018
• Study Start: January 23, 2019
• Primary Completion: May 18, 2022
• Study Completion: December 1, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

TH (1)