Gambia Pertussis Study (GaPs)

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Brief Title

Gambia Pertussis Study (GaPs)

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

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?
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

PT specific antibody GMC

Secondary Outcome

 PT specific antibody

Condition

Pertussis

Intervention

Boostrix IPV infant acellular Pertussis

Study Arms / Comparison Groups

 Boostrix IPV - infant acellular Pertussis (TdaP-aP)
Description:  vaccination of the mother with Boostrix-IPV vaccine which includes the infant acellular pertussis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

600

Start Date

January 23, 2019

Completion Date

December 2022

Primary Completion Date

October 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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

          -  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
      

Gender

Female

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Beate Kampmann, MD, PhD, +220-4495442-6, [email protected]

Location Countries

Gambia

Location Countries

Gambia

Administrative Informations


NCT ID

NCT03606096

Organization ID

SCC 1600


Responsible Party

Sponsor

Study Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

 University of Oxford

Study Sponsor

Beate Kampmann, MD, PhD, Principal Investigator, MRC Unit at LSHTM


Verification Date

June 2020