PertussisPhase 4GaPsNCT03606096
Gambia Pertussis Study (GaPs)
A Phase 4 study testing Boostrix IPV infant acellular Pertussis, Boostrix IPV infant whole Pertussis and TT infant acellular Pertussis in people with Pertussis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Boostrix IPV infant acellular Pertussis, Boostrix IPV infant whole Pertussis and TT infant acellular Pertussis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteThe Gambia
- Study dates
- 23 Jan 2019to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 27Show fewer
- 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
- Receipt of any vaccine during the current pregnancy or plans to receive any non-study vaccines during the current pregnancy (tetanus toxoid vaccination is not an exclusion and vaccines given during national campaigns if applicable will not generally be exclusions)
- Any other condition judged to significantly increase the risks to either the mother or the infant within the current pregnancy (including relevant history from previous pregnancies)
- History of anaphylactic or severe allergic reactions to previous vaccines or history of anaphylactic or severe allergic reactions in previous offspring (if applicable)
- Receipt of any blood product including human immunoglobulins at any stage during the current pregnancy or plan to receive any blood products during the period or trial participation (receipt or blood products in an emergency or for obstetric reasons will not represent a protocol deviation given such situations are unplanned)
- Receipt of immunosuppressive or immuno-modulatory medication at any stage during the current pregnancy or plan to receive any such medication during the period or trial participation
- Clinically suspected or confirmed congenital or acquired clotting or bleeding disorders or the current receipt of medications known to alter clotting or bleeding
- Current malaria infection (on the day of randomization and vaccination)
- Any clinically significant signs or symptoms of acute illness, significant abnormalities in vital signs, an axillary temperature of greater than 38.0°C or any recorded fever (greater than 38.0°C) in the preceding 24 hours.
- Two or more symptoms (nausea/vomiting, diarrhoea, headaches, fatigue and myalgia) rated as grade 2 and clinically significant on the maternal systemic reactogenicity scale (2 Table 5) present at baseline on the day of vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized
- involuntarily
- Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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?
Read the detailed description
The investigators are conducting a randomised, controlled, double-blinded, clinical vaccine trial in pregnant women combined with an open-label controlled Phase IV clinical vaccine trial in their infants.
The trial will examine the differences in immunity generated by aP compared with wP in infants at 5 and 9 months of age, and examine the impact of maternal antibodies on the immune response of infants receiving aP or wP vaccines at two, three and four months.
The investigators aim to address two key question: 1. If measures of immunity in infants given aP or wP differ by 5 and 9 months of age; and 2: If and- if so- how maternal pertussis antibodies affect the development and maintenance of immunity to Bordetella pertussis in infants.
Rationale for the trial:
Pertussis (whooping cough) is an infectious disease that can be very serious- particularly in young infants- but preventable through vaccination. There are two types of vaccines: acellular (aP) and whole cell (wP) vaccines, both extensively used worldwide. A clearer understanding of how these two different types of vaccines work is fundamental when considering adjustments or rethinking vaccination strategies and such knowledge will help the future development of new vaccines, given that some LMIC have already introduced aP but the current WHO recommendation still continues to recommend wP vaccine for those who have not yet switched.
Increases in the incidence of pertussis infection, including fatal cases in young infants, have been recently observed in many regions in the world, more likely associated with the use of aP vaccines. As a consequence, it is now recommended in several countries that women should receive aP vaccination in pregnancy so that their high levels of pertussis antibody which will be passed on via the placenta can protect their babies in early life, before the infants have received sufficient doses of pertussis vaccine themselves. However, it is currently unclear if and how maternal antibodies affect long-term immunity to pertussis in infants.
Unlike in the UK, where many women of childbearing age would have received aP vaccine in childhood, in The Gambia, all women would have been primed with wP vaccine as part of the NIP. Hence a study in this group of women is uniquely placed to assess if different priming regimens could have different quantitative and qualitative effects on transplacental antibody transfer for pertussis antibody, providing additional insights in comparison to parallel studies in Europe under the PERISCOPE consortium (PERtussIS COrrelates of Protection Europe).
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.
Trial design:
The investigators will recruit 600 mother/infant pairs. Following informed consent, sensitisation and eligibility checks including antenatal ultrasound to date the pregnancy, pregnant women will be randomised to receive either Boostrix IPV (contains antigens against pertussis, tetanus, diphteria and polio)- a vaccine recommended for pregnant women in the UK and other countries where recent pertussis outbreaks have been observed, or the tetanus vaccine routinely recommended for women in LMIC.
Pre vaccination antibody titres will be measured in the women prior to vaccination between 28-34 week gestation and vaccine responses measured subsequently at the time of giving birth. Cord blood will be collected to measure transfer of maternal antibody. Infants will be grouped to receive either aP or wP at 2,3 and 4 months of age, in line with routine EPI programs. Blood samples will be collected from infants prior to vaccination and following doses of vaccines at specific intervals to measure innate and acquired immune responses and followed up until 9 months of age. Infants will be allocated to subgroups for blood tests so that no infant will have between 4 and max 5 episodes of blood sampling up to the age of 9 months.
Samples will be processed for quantitative and qualitative antibody, innate and acquired cellular immune responses. Where available, samples will be stored for further investigations using transcriptomic and epigenetic methodologies. Samples, results and data will be shared with the PERISCOPE consortium members.
- Conditions
- Pertussis
- Being tested
- Boostrix IPV infant acellular Pertussis, Boostrix IPV infant whole Pertussis, TT infant acellular Pertussis, TT infant whole Pertussis
- Keywords
- immune response, impact of acellular pertussis vaccination
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix IPV infant acellular PertussisBiological
mother is randomized to receive Boostrix ® Polio (GSK) and infant acellular pertussis
Boostrix IPV infant whole PertussisBiological
mother is randomized to receive Boostrix ® Polio (GSK) and infant whole Pertussis
TT infant acellular PertussisBiological
mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis
TT infant whole PertussisBiological
mother is randomised to receive Tetanus Toxoid and infant whole Pertussis
| Study group | Role | What they receive |
|---|---|---|
| Boostrix IPV - infant acellular Pertussis (TdaP-aP) | Experimental | vaccination of the mother with Boostrix-IPV vaccine which includes the infant acellular pertussis Receives: 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 Receives: Biological: Boostrix IPV infant whole Pertussis |
| TT - infant acellular Pertussis (T-ap ) | Active comparator | vaccination of mother with TT-which includes infant acellular pertussis Receives: Biological: TT infant acellular Pertussis |
| TT - infant whole Pertussis (T-wP) | Active comparator | vaccination of mother with T which includes infant whole cell pertussis Receives: Biological: TT infant whole Pertussis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PT specific antibody GMC
PT-specific antibody GMC at 20 weeks in infants vaccinated with aP versus wP
Measured: 20 weeks
PT specific antibody GMC
PT-specific antibody GMC at 9 months in infants vaccinated with aP versus wP
Measured: 9 months
Secondary outcomes (9)
PT specific antibody
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.
Measured: at 20 weeks and 9 months
change in PT, FHA, and PRN antibody concentrations
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
Measured: at 8 and 20 weeks and at 9 months of age
Pertussis antigen-specific memory B-cell
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
Measured: at 8, 16 weeks and at 9 months of age
Pertussis antigen-specific Th1, Th2 and Th17 responses
Pertussis antigen-specific Th1, Th2 and Th17 responses determined by flow-cytometry and cytokine analysis following antigen-specific culture (the 'Rapid T-cell assay').
Measured: at 16 weeks of age of the infant
PT, FHA and PRN-specific antibody GMC and GMR
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.
Measured: at baseline (cord blood baseline) and at 8, 20 weeks and at 9 months
Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody
Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody concentrations
Measured: at 8, 20 weeks and 9 months
Serious adverse events (SAE) in expectant mothers
Serious adverse events (SAE) in expectant mothers from enrollment at 28-34 weeks gestation up to eight weeks from the end of pregnancy.
Measured: at 28-34 weeks gestation up to eight weeks from the end of pregnancy.
local and systemic reactogenicity
Proportion of mothers 28-34 weeks gestation with local and systemic reactogenicity within the first three days of aP administration
Measured: within first 3 days of aP administration
PT specific antibody
PT-specific antibody GMC 9 months post delivery
Measured: at 9 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start23 Jan 2019
- Primary completion18 May 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, National Institute for Public Health and the Environment (RIVM), Radboud University Medical Center, Imperial College London, University of Turku, Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Beate Kampmann, MD, PhD, Principal investigator, MRC Unit at LSHTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606096
- Sponsor's protocol ID
- SCC 1600
- Acronym
- GaPs
- Status last verified
- Mar 2022
- First submitted
- 2 Jul 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Jan;7(1):101219. doi: 10.1016/j.lanmic.2025.101219. Epub 2026 Jan 7.
PubMed 41519134Saso 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.
PubMed 40154521Saso 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.
PubMed 39951075
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03606096
- Acronym / sponsor ID
- GaPs / SCC 1600
- Conditions
- Pertussis
- Keywords
- immune response, impact of acellular pertussis vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Oxford, National Institute for Public Health and the Environment (RIVM), Radboud University Medical Center, Imperial College London, University of Turku, Leiden University Medical Center
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 18 May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The investigators are conducting a randomised, controlled, double-blinded, clinical vaccine trial in pregnant women combined with an open-label controlled Phase IV clinical vaccine trial in their infants.
The trial will examine the differences in immunity generated by aP compared with wP in infants at 5 and 9 months of age, and examine the impact of maternal antibodies on the immune response of infants receiving aP or wP vaccines at two, three and four months.
The investigators aim to address two key question: 1. If measures of immunity in infants given aP or wP differ by 5 and 9 months of age; and 2: If and- if so- how maternal pertussis antibodies affect the development and maintenance of immunity to Bordetella pertussis in infants.
Rationale for the trial:
Pertussis (whooping cough) is an infectious disease that can be very serious- particularly in young infants- but preventable through vaccination. There are two types of vaccines: acellular (aP) and whole cell (wP) vaccines, both extensively used worldwide. A clearer understanding of how these two different types of vaccines work is fundamental when considering adjustments or rethinking vaccination strategies and such knowledge will help the future development of new vaccines, given that some LMIC have already introduced aP but the current WHO recommendation still continues to recommend wP vaccine for those who have not yet switched.
Increases in the incidence of pertussis infection, including fatal cases in young infants, have been recently observed in many regions in the world, more likely associated with the use of aP vaccines. As a consequence, it is now recommended in several countries that women should receive aP vaccination in pregnancy so that their high levels of pertussis antibody which will be passed on via the placenta can protect their babies in early life, before the infants have received sufficient doses of pertussis vaccine themselves. However, it is currently unclear if and how maternal antibodies affect long-term immunity to pertussis in infants.
Unlike in the UK, where many women of childbearing age would have received aP vaccine in childhood, in The Gambia, all women would have been primed with wP vaccine as part of the NIP. Hence a study in this group of women is uniquely placed to assess if different priming regimens could have different quantitative and qualitative effects on transplacental antibody transfer for pertussis antibody, providing additional insights in comparison to parallel studies in Europe under the PERISCOPE consortium (PERtussIS COrrelates of Protection Europe).
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.
Trial design:
The investigators will recruit 600 mother/infant pairs. Following informed consent, sensitisation and eligibility checks including antenatal ultrasound to date the pregnancy, pregnant women will be randomised to receive either Boostrix IPV (contains antigens against pertussis, tetanus, diphteria and polio)- a vaccine recommended for pregnant women in the UK and other countries where recent pertussis outbreaks have been observed, or the tetanus vaccine routinely recommended for women in LMIC.
Pre vaccination antibody titres will be measured in the women prior to vaccination between 28-34 week gestation and vaccine responses measured subsequently at the time of giving birth. Cord blood will be collected to measure transfer of maternal antibody. Infants will be grouped to receive either aP or wP at 2,3 and 4 months of age, in line with routine EPI programs. Blood samples will be collected from infants prior to vaccination and following doses of vaccines at specific intervals to measure innate and acquired immune responses and followed up until 9 months of age. Infants will be allocated to subgroups for blood tests so that no infant will have between 4 and max 5 episodes of blood sampling up to the age of 9 months.
Samples will be processed for quantitative and qualitative antibody, innate and acquired cellular immune responses. Where available, samples will be stored for further investigations using transcriptomic and epigenetic methodologies. Samples, results and data will be shared with the PERISCOPE consortium members.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Boostrix IPV - infant acellular Pertussis (TdaP-aP) | Experimental | Biological: Boostrix IPV infant acellular Pertussisvaccination of the mother with Boostrix-IPV vaccine which includes the infant acellular pertussis |
| Boostrix IPV - infant whole Pertussis (Tdap-wP ) | Experimental | Biological: Boostrix IPV infant whole Pertussisvaccination of mother with Boostrix -IPV which includes infant whole cell pertussis |
| TT - infant acellular Pertussis (T-ap ) | Active comparator | Biological: TT infant acellular Pertussisvaccination of mother with TT-which includes infant acellular pertussis |
| TT - infant whole Pertussis (T-wP) | Active comparator | Biological: TT infant whole Pertussisvaccination of mother with T which includes infant whole cell pertussis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boostrix IPV infant acellular Pertussismother is randomized to receive Boostrix ® Polio (GSK) and infant acellular pertussis | Biological | Boostrix IPV - infant acellular Pertussis (TdaP-aP) |
| Boostrix IPV infant whole Pertussismother is randomized to receive Boostrix ® Polio (GSK) and infant whole Pertussis | Biological | Boostrix IPV - infant whole Pertussis (Tdap-wP ) |
| TT infant acellular Pertussismother is randomised to receive Tetanus Toxoid and infant acellular Pertussis | Biological | TT - infant acellular Pertussis (T-ap ) |
| TT infant whole Pertussismother is randomised to receive Tetanus Toxoid and infant whole Pertussis | Biological | TT - infant whole Pertussis (T-wP) |
Primary outcome
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
9 secondary outcomes
PT specific antibody
Time frame: at 20 weeks and 9 months
change in PT, FHA, and PRN antibody concentrations
Time frame: at 8 and 20 weeks and at 9 months of age
Pertussis antigen-specific memory B-cell
Time frame: at 8, 16 weeks and at 9 months of age
Pertussis antigen-specific Th1, Th2 and Th17 responses
Time frame: at 16 weeks of age of the infant
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
Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody
Time frame: at 8, 20 weeks and 9 months
Serious adverse events (SAE) in expectant mothers
Time frame: 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
PT specific antibody
Time frame: at 9 months post delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 41519134Saso 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 Jan;7(1):101219. doi: 10.1016/j.lanmic.2025.101219. Epub 2026 Jan 7.
- Derived from this study: PubMed 40154521Saso 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.
- Derived from this study: PubMed 39951075Saso 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.
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Kampmann, MD, PhD principal investigator
MRC Unit at LSHTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix IPV infant acellular Pertussis, Boostrix IPV infant whole Pertussis and TT infant acellular Pertussis in people with Pertussis, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PT specific antibody GMC (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606096, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.