The number of reported pertussis cases is rising, also in very young infants. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix
Pharmaceutical Form: Suspension for injection
Other descriptive name: DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria - Women aged 18-35 years - Willing to be immunized during pregnancy OR Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner. - Age matched controls will be identified in the same time period in the recruiting hospital. - Intend to be available for follow-up visits and phone call access through 16 months following delivery - Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination. - In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician and some of the following criteria: 1. Second trimester ultrasound with no significant abnormalities 2. No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis) 3. Pregnancy estimated to be at low risk (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A. Pregnant women - Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections). - Significant mental illness (e.g. schizophrenia, psychosis, major depression) - History of a febrile illness (greater than or equal to 38° Celsius) within the past 72 hours before injection - Previous severe reaction to any vaccine - Receipt of tetanus-diphtheria toxoid immunization within the past 2 years - Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years - Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection - Receipt of or plans to receive influenza vaccine within the 2 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms). - Deemed high risk for serious obstetrical complication - Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk B. Children with following criteria - Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections). - No signed informed consent by both parents - Severe reactions to any vaccine - Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), reduce the gap of susceptibility to pertussis disease in newborns by augmenting maternal antibody concentrations?;Secondary Objective: Is there a difference in humoral immune responses to pertussis containing vacicnes, between children from women who received a booster vaccine during pregnancy and age matched control infants? Safety data on vaccination during pregnancy;Primary end point(s): 1.What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN): a.in women during pregnancy and at delivery after vaccination with TdaP b.in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16) 2.What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants ;Timepoint(s) of evaluation of this end point: Women: vaccination between 18 and 32 weeks of pregnancy, blood sampling one month after vaccination, blood sampling at delivery. Children are included after delivery and 2 different groups can be recognized according to whether the mother received a booster vaccine. Infants are offered pertussis immunization according to the official recommendations in Flanders, at week 8, 12, 16 (hexavalent vaccine), at month 15 and year 6 (tetravalent vaccine). Blood sampling will be performed (2.5 cc) from the cord and in the children at week 8 (pre-vaccination), week 20 (after vaccination), month 15 (pre-boost) and month 16 (post-booster vaccination).The aim is to take 2,5 cc of whole blood per sampling time point in child | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures: a. Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time b. Infant growth measurements (head circumference, length and weight) at all time points c. Developmental screening of the infants (at 15 months of age) d. Compare the immune mechanisms to age-matched infants, whose mothers did not receive a pertussis booster vaccination during the last 10 years before pregnancy. ;Timepoint(s) of evaluation of this end point: Women: vaccination between 18 and 32 weeks of pregnancy, blood sampling one month after vaccination, blood sampling at delivery. Children are included after delivery and 2 different groups can be recognized according to whether the mother received a booster vaccine. Infants are offered pertussis immunization according to the official recommendations in Flanders, at week 8, 12, 16 (hexavalent vaccine), at month 15 and year 6 (tetravalent vaccine). Blood sampling will be performed (2.5 cc) from the cord and in the children at week 8 (pre-vaccination), week 20 (after vaccination), month 15 (pre-boost) and month 16 (post-booster vaccination).The aim is to take 2,5 cc of whole blood per sampling time point in children. | — |
Countries
Belgium
Outcome results
None listed