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

Primary Purpose

Responses to Infant Immunisations

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Repevax
Boostrix-IPV
Sponsored by
Public Health England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Responses to Infant Immunisations focused on measuring pertussis, maternal vaccination, maternal immunisation, immune response

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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"

Sites / Locations

  • Gloucestershire
  • Hertfordshire
  • St George's Vaccine Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Repevax

Boostrix-IPV

unvaccinated

Arm Description

Repevax in pregnancy

Boostrix-IPV in pregnancy

unvaccinated mothers

Outcomes

Primary Outcome Measures

PT immunogenicity (IgG GMC)
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.
Immunogenicity of pertussis antigens (IgG GMC)
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
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)
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

Secondary Outcome Measures

Full Information

First Posted
May 13, 2014
Last Updated
September 29, 2020
Sponsor
Public Health England
Collaborators
Institute of Child Health, St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT02145624
Brief Title
A Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants
Acronym
iMAP2
Official Title
A Randomised Controlled Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health England
Collaborators
Institute of Child Health, St George's, University of London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Responses to Infant Immunisations
Keywords
pertussis, maternal vaccination, maternal immunisation, immune response

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
366 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repevax
Arm Type
Active Comparator
Arm Description
Repevax in pregnancy
Arm Title
Boostrix-IPV
Arm Type
Active Comparator
Arm Description
Boostrix-IPV in pregnancy
Arm Title
unvaccinated
Arm Type
No Intervention
Arm Description
unvaccinated mothers
Intervention Type
Drug
Intervention Name(s)
Repevax
Other Intervention Name(s)
Pertussis containing vaccine
Intervention Description
vaccine
Intervention Type
Drug
Intervention Name(s)
Boostrix-IPV
Other Intervention Name(s)
Pertussis containing vaccine
Intervention Description
vaccine
Primary Outcome Measure Information:
Title
PT immunogenicity (IgG GMC)
Description
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.
Time Frame
Birth, 2, 5 and 13 months of age
Title
Immunogenicity of pertussis antigens (IgG GMC)
Description
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
Time Frame
Birth, 2, 5 and 13 months of age
Title
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)
Description
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
Time Frame
Birth, 2, 5 and 13 months of age
Other Pre-specified Outcome Measures:
Title
immunogenicity of pnuemococcal conjugate vaccine
Description
immunogenicity of pnuemococcal conjugate vaccine
Time Frame
birth, 2, 5 13 months
Title
immunogenicity of meningococcal conjugate vaccine
Description
immunogenicity of meningococcal conjugate vaccine
Time Frame
birth, 2, 5, 13 months
Title
immunogenicity of diphtheria vaccine
Description
immunogenicity of diphtheria vaccine
Time Frame
borth 2, 5, 13 months
Title
immunogenicity of pertussis vaccination
Description
immunogenicity of pertussis vaccination
Time Frame
birth, 2, 5, 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Coates, PhD
Organizational Affiliation
Public Health England
Official's Role
Study Chair
Facility Information:
Facility Name
Gloucestershire
City
Gloucestershire
Country
United Kingdom
Facility Name
Hertfordshire
City
Hertfordshire
Country
United Kingdom
Facility Name
St George's Vaccine Institute
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34098951
Citation
Jones CE, Calvert A, Southern J, Matheson M, Andrews N, Khalil A, Cuthbertson H, Hallis B, England A, Heath PT, Miller E. A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants. BMC Med. 2021 Jun 8;19(1):138. doi: 10.1186/s12916-021-02005-5.
Results Reference
derived
Links:
URL
https://www.gov.uk/government/organisations/public-health-england
Description
PHE website

Learn more about this trial

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

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