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A Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants (iMAP2)

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ClinicalTrials.gov Identifier: NCT02145624
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Institute of Child Health
St George's, University of London
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Public Health England

Brief Summary:

Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the Department of Health acted to protect newborns between birth and completion of primary immunisations, the period with greatest risk of disease.

Vaccination of pregnant women with whooping cough vaccine in the third trimester of pregnancy was instigated nationally, so that antibodies produced by the Mum would cross the placenta to the unborn child, giving them passive protection at the most vulnerable time. This antibody transfer has been known for some time but has not been compared between the two whooping cough vaccines being used in pregnancy. Any effect the raised antibody might have on infant responses to the vaccines given in the first few months of life has also not been measured. This is particularly important as the infant immunisations include some of the same components as the whooping cough vaccines, which include diphtheria, tetanus and polio. Previous studies have shown that high levels of antibody prior to vaccination may affect subsequent antibody responses. It is therefore important to assess whether administration of the whooping cough vaccine in pregnancy adversely affects the protection afforded by the infant vaccines, particularly to those which are similar, namely tetanus and diphtheria as well as meningitis C and Hib vaccines which include diptheria and tetanus components in their structures. This study will assess immune responses of mothers and their babies (~200 pairs) to their vaccinations and will allow the comparison of two whooping cough vaccines being used in pregnancy. This will be done by taking small amounts of blood, which is the only way to measure antibody levels (the proxy of the immune response), before and after the vaccinations. A group of unvaccinated women and their babies (50 pairs) will also be recruited to allow comparison of their immune responses.


Condition or disease Intervention/treatment Phase
Responses to Infant Immunisations Drug: Repevax Drug: Boostrix-IPV Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants
Study Start Date : October 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough
Drug Information available for: Boostrix

Arm Intervention/treatment
Active Comparator: Repevax
Repevax in pregnancy
Drug: Repevax
vaccine
Other Name: Pertussis containing vaccine

Active Comparator: Boostrix-IPV
Boostrix-IPV in pregnancy
Drug: Boostrix-IPV
vaccine
Other Name: Pertussis containing vaccine

No Intervention: unvaccinated
unvaccinated mothers



Primary Outcome Measures :
  1. PT immunogenicity (IgG GMC) [ Time Frame: Birth, 2, 5 and 13 months of age ]
    To compare antiPertussis Toxin (PT) IgG responses following primary immunisation with an acellular pertussiscontaining vaccine in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy.

  2. Immunogenicity of pertussis antigens (IgG GMC) [ Time Frame: Birth, 2, 5 and 13 months of age ]
    To compare antibody responses to pertussis antigens (concentration of IgG antibody to PT, pertactin (PRN), filamentous haemagglutinnin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3]), tetanus toxoid and diphtheria toxoid at birth amongst infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy

  3. Immunogenicity of infant immunisations - pertussis antigens, meningococcal serogroup C, pnuemococcal vaccines at 2, 5 and 13 months of age, (all IgG GMC and SBA GMT for MenC) [ Time Frame: Birth, 2, 5 and 13 months of age ]
    To compare antibody responses to pertussis antigens [IgG to PT, PRN, FHA and FIM 2 and 3], Hib antigen [PRP], tetanus toxoid and diphtheria toxoid; meningococcal serogroup C serum bactericidal antibody titres and meningococcal serogroup Cspecific IgG concentrations; 13 serotypespecific pneumococcal IgG concentrations and functional pneumococcal antibody studies at 2, 5 and 13 months of age (just before and one month after primary immunization and one month after booster vaccines) in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy and compared to infants whose mothers who did not receive pertussis vaccination in pregnancy


Other Outcome Measures:
  1. immunogenicity of pnuemococcal conjugate vaccine [ Time Frame: birth, 2, 5 13 months ]
    immunogenicity of pnuemococcal conjugate vaccine

  2. immunogenicity of meningococcal conjugate vaccine [ Time Frame: birth, 2, 5, 13 months ]
    immunogenicity of meningococcal conjugate vaccine

  3. immunogenicity of diphtheria vaccine [ Time Frame: borth 2, 5, 13 months ]
    immunogenicity of diphtheria vaccine

  4. immunogenicity of pertussis vaccination [ Time Frame: birth, 2, 5, 13 months ]
    immunogenicity of pertussis vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Pregnant women who, at the time of enrolment

• are aged 1645 years Infants of the women recruited will also be seen during the study. They will be given their immunisations according to the routine childhood immunisation schedule and will have blood samples collected as detailed in the clinical procedures section of this form. Their inclusion/ exclusion will be as per the Green Book recommendations by the UK Dept of Health.

Exclusion Criteria:

Participants may not be included in the study if any of the following apply:

All women:

  • Bleeding disorder
  • Receipt of any pertussis containing vaccine in the previous 12 months

Women to be vaccinated only (i.e. not the control group):

  • Received immunoglobulin or other blood product within the preceding 3 months
  • Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/publichealthenglan d/series/immunisationagainstinfectiousdiseasethegreenbook), including:

    • A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine
    • A confirmed anaphylactic reaction to any component of the vaccine
    • A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine
    • Temporary Exclusion Criteria If the pregnant woman or the baby has an axillary/aural temperature ≥ 38°C, then vaccination and blood sampling will be postponed until resolution of fever. If the pregnant woman or baby is acutely unwell, vaccination will postponed until resolution. Blood sampling will also be postponed for seven days after completion of any antibiotic course.

Infants will be vaccinated under the routine national immunisation schedule in accordance with the inclusion/ exclusion criteria set out in the Department of Health "Green Book"


Information from the National Library of Medicine

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): NCT02145624


Locations
United Kingdom
Gloucestershire
Gloucestershire, United Kingdom
Hertfordshire
Hertfordshire, United Kingdom
St George's Vaccine Institute
London, United Kingdom
Sponsors and Collaborators
Public Health England
Institute of Child Health
St George's, University of London
Investigators
Study Chair: Elizabeth Coates, PhD Public Health England

Additional Information:
Responsible Party: Prof. Elizabeth Miller, Consultant Epidemiologist, Public Health England
ClinicalTrials.gov Identifier: NCT02145624     History of Changes
Other Study ID Numbers: iMAP2
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Elizabeth Miller, Public Health England:
pertussis
maternal vaccination
maternal immunisation
immune response

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs