Gambia Pertussis Study (GaPs) (GaPs)
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|ClinicalTrials.gov Identifier: NCT03606096|
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 1, 2020
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?
|Condition or disease||Intervention/treatment||Phase|
|Pertussis||Biological: Boostrix IPV infant acellular Pertussis Biological: Boostrix IPV infant whole Pertussis Biological: TT infant acellular Pertussis Biological: TT infant whole Pertussis||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Randomised, Double-blinded, Open Label Study in Pregnant Women, Exploring the Impact of Acellular Pertussis Vaccination in Pregnancy on the Immunogenicity in Infants Randomized to Receive Either an Acellular (aP) or Whole Cell Pertussis (wP) Vaccine Subsequently|
|Actual Study Start Date :||January 23, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Boostrix IPV - infant acellular Pertussis (TdaP-aP)
vaccination of the mother with Boostrix-IPV vaccine which includes the infant acellular pertussis
Biological: Boostrix IPV infant acellular Pertussis
mother is randomized to receive Boostrix ® Polio (GSK) and infant acellular pertussis
Experimental: Boostrix IPV - infant whole Pertussis (Tdap-wP )
vaccination of mother with Boostrix -IPV which includes infant whole cell pertussis
Biological: Boostrix IPV infant whole Pertussis
mother is randomized to receive Boostrix ® Polio (GSK) and infant whole Pertussis
Active Comparator: TT - infant acellular Pertussis (T-ap )
vaccination of mother with TT-which includes infant acellular pertussis
Biological: TT infant acellular Pertussis
mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis
Active Comparator: TT - infant whole Pertussis (T-wP)
vaccination of mother with T which includes infant whole cell pertussis
Biological: TT infant whole Pertussis
mother is randomised to receive Tetanus Toxoid and infant whole Pertussis
- PT specific antibody GMC [ Time Frame: 20 weeks ]PT-specific antibody GMC at 20 weeks in infants vaccinated with aP versus wP
- PT specific antibody GMC [ Time Frame: 9 months ]PT-specific antibody GMC at 9 months in infants vaccinated with aP versus wP
- PT specific antibody [ Time Frame: at 20 weeks and 9 months ]PT-specific antibody GMC at 20 weeks and 9 months in infants vaccinated with aP versus wP following maternal vaccination with Boostrix ® Polio (GSK) or Tetanus Toxoid.
- change in PT, FHA, and PRN antibody concentrations [ Time Frame: at 8 and 20 weeks and at 9 months of age ]Proportion with a 2-fold reduction in PT, FHA, and PRN antibody concentrations (measured in cord blood) from baseline at 8, 20 weeks and 9 months of age in aP versus wP primed infants following maternal immunisation with Boostrix ® Polio (GSK) or Tetanus Toxoid
- Pertussis antigen-specific memory B-cell [ Time Frame: at 8, 16 weeks and at 9 months of age ]Pertussis antigen-specific memory B-cell frequencies at 8,16 weeks and 9 months of age measured by ELISpot in the aP versus wP group following maternal immunisation with aP or Boostrix ® Polio (GSK) or Tetanus Toxoid
- Pertussis antigen-specific Th1, Th2 and Th17 responses [ Time Frame: at 16 weeks of age of the infant ]Pertussis antigen-specific Th1, Th2 and Th17 responses determined by flow-cytometry and cytokine analysis following antigen-specific culture (the 'Rapid T-cell assay').
- PT, FHA and PRN-specific antibody GMC and GMR [ Time Frame: at baseline (cord blood baseline) and at 8, 20 weeks and at 9 months ]PT, FHA and PRN-specific antibody GMC and GMR prior to immunisation (cord blood baseline) and at 8, 20 weeks and 9 months of age.
- Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody [ Time Frame: at 8, 20 weeks and 9 months ]Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody concentrations
- Serious adverse events (SAE) in expectant mothers [ Time Frame: at 28-34 weeks gestation up to eight weeks from the end of pregnancy. ]Serious adverse events (SAE) in expectant mothers from enrollment at 28-34 weeks gestation up to eight weeks from the end of pregnancy.
- local and systemic reactogenicity [ Time Frame: within first 3 days of aP administration ]Proportion of mothers 28-34 weeks gestation with local and systemic reactogenicity within the first three days of aP administration
- PT specific antibody [ Time Frame: at 9 months post delivery ]PT-specific antibody GMC 9 months post delivery
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): NCT03606096
|Contact: Beate Kampmann, MD, PhDfirstname.lastname@example.org|
|Contact: Michael E Okoye, MBBS||+220-4495443-6 ext email@example.com|
|Sukuta Health Centre||Recruiting|
|Sukuta, Banjul, Gambia|
|Contact: Michael E Okoye, MBBS 220-4405443-6 ext 3034 firstname.lastname@example.org|
|Principal Investigator:||Beate Kampmann, MD, PhD||MRC Unit at LSHTM|