Vaccine responses
Conditions
Interventions
Trade Name: BCG Vaccine SSI
Product Name: BCG Vaccine SSI
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: M
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy male or female babies aged 7 days or under • Born at term (= 36 completed weeks of gestation) • Valid informed consent provided by an individual with parental responsibility (parent or legal guardian) • Living within the Thames Valley region at enrolment without intention to move out of this region during the course of the study • Parents or legal guardians must be aged 18 years or over • Parent or legal guardian is able (in the Investigator’s opinion) and willing to comply with all study requirements • Parent or legal guardian consent provided for General Practitioner and consultant, if appropriate, to be notified of participation in the study • Parent or legal guardian consent to review hospital birth records before enrolment and inform GP or Consultant of involvement in study, if appropriate Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Confirmed, suspected or significant risk of immunodeficiency (including but not limited to: maternal history of Human Immunodeficiency Virus infection, family history of congenital or hereditary immunodeficiency and receipt of significant immunosuppressive medication by the participant during the study, or by the mother prior to delivery) • Receipt of BCG or another live vaccine prior to enrolment • Receipt of any vaccine, either prior to enrolment or planned during the study, except for: - those listed in the study protocol at the times indicated - hepatitis A or B vaccine or influenza vaccine. • Receipt prior to enrolment, or planned receipt during the study, of monoclonal antibodies, immunoglobulin or any blood product • A baby who would normally be offered BCG at birth under current Department of Health guidance3. This means: - babies living in an area of the UK with an annual incidence of TB >40 / 100,000 or - babies who have a parent or grandparent who was born in a country with an annual incidence of TB >40 / 100,000 • Confirmed or suspected household contact with active TB • Confirmed or suspected anaphylaxis to any component of BCG or other study vaccine • Any confirmed or suspected serious medical condition (including seizures, neurological conditions, major congenital abnormalities or malignancy) • Any condition significantly increasing the risk of intussusception (including previous history of intussusception, known malrotation or other significant anatomical gastrointestinal abnormality) • Receipt of systemic antimicrobial medication since birth • Parents or legal guardians should not be members of the study team or named on the study delegation log • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the potential participant (or carer) at risk because of participation in the study, or may influence the result of the study, or the potential participant’s ability to participate in the study. • A potential participant who has participated or is participating in another research study involving an investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): MenC-specific IgG at 8 weeks following the dose of MenC vaccine ;Timepoint(s) of evaluation of this end point: At 20 weeks of age if no delay in the schedule;Main Objective: To characterise the impact of BCG immunisation given at birth or 3 months of age on the initial response to infant serogroup C meningococcal vaccine (MenC).; Secondary Objective: Secondary Objective • To describe immunogenicity of the MenC component of Hib-MenC at 12 months and 13 months of age in BCG-naïve and immunised individuals Exploratory Objectives • To describe detectable T-cell responses to TB, BCG, MenC and polyclonal stimuli in BCG-naïve and immunised individuals where blood volume and resources allow • To examine the effect of BCG immunisation on gene expression where blood volume and resources allow • To compare immunogenicity to other primary immunisations in BCG-naïve and immunised individuals where blood volume and resources allow • To examine whether monocyte / lymphocyte are related to subsequent vaccine responses | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. At 12 months and 13 months of age 2. At 20 weeks of age if no delay in the schedule and at 12 months and 13 months of age. 3. At 20 weeks of age if no delay in the schedule and at 12 months and 13 months of age. ; Secondary end point(s): Secondary Endpoints • MenC-specific IgG just before and 4 weeks after the dose of Hib-MenC vaccine (i.e. at 12 months and 13 months of age) • MenC serum bactericidal antibody (SBA) at 8 weeks following the dose of MenC vaccine and just before and 4 weeks after the dose of Hib-MenC vaccine • MenC SBA at each of the same time points Exploratory Endpoints These assays will be dependent on sufficient blood volume and resources to enable them to be undertaken: • Cellular responses to MenC conjugate protein at 8 weeks following the dose of MenC vaccine and just before and 4 weeks after the dose of Hib-MenC vaccine • Cellular responses to TB antigens (e.g. purified protein derivative, PPD) 8 weeks after BCG (or 8 weeks after birth in Group 3) and at 1 yr of age • The relative abundance (ratio to baseline) of gene expression (measured by gene expression microarrays and/or mRNA-seq technologies) at 8 weeks following BCG (or 8 weeks after birth in Group 3) and at 1 yr of age • Fold-change (ratio to baseline) in concentration of cytokines in cell culture supernatant and/or ex-vivo plasma samples at birth, 12 weeks, 20 weeks and 52 weeks (including but not limited to: IFN?, TNFa, IL1a, IL1ß, IL2, IL6, IL10, IL12, IL13, MIP1a, MIP1ß, MCP-1) • Plasma rotavirus-specific IgA 8 weeks following the dose of MenC vaccine (i.e. at approximately 20 weeks of age) and at approximately 12 months of age • Immunogenicity of other primary immunisations delivered in the routine | — |
Countries
United Kingdom
Contacts
Public ContactOxford Vaccine Group
University of Oxford
Outcome results
None listed