Gambia Pertussis Study (GaPs) (GaPs)

This is an interventional prevention trial for Pertussis focused on measuring immune response, impact of acellular pertussis vaccination Read More

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