The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses

Antibiotic Treatment Clinical Trial

Official title:

The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06079606
• Other study ID #: e-INFANT-2
• Status: Active, not recruiting
• Start date: September 10, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Landspitali University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective cohort study will include 200 term children born in Landspitali University Hospital in Iceland. The cohort will be divided into four groups according to antibiotic exposure of which one is the control group. Children's immune responses to live oral rotavirus vaccine as well as conventional vaccinations given at three, five and 12 months old will be determined by measuring salivary and serologic responses. Responses will be compared between the four groups. Stool samples will also be collected from participants and the composition of the microbiome compared between the four groups.

Description:

This prospective cohort study will evaluate the development of the immune system by means of evaluating the immune responses to oral rotavirus vaccine and the scheduled childhood vaccinations in Iceland, at the age of three, five and 12 months, in four different groups of term children born in Iceland.

The cohort will be divided into the following groups:

• Group A: Term children born with elective caesarean section (their mothers received intra-operative antibiotics).

• Group B: Term vaginally born children and their mothers received intra-partum antibiotics.

• Group C: Term vaginally born children that received systemic antibiotics during the first week of life for at least 48 hours.

• Group D: Term vaginally born children that had not received systemic antibiotics at the time of recruitment.

Parents of children born with elective caesarean section in Landspitali or born vaginally and their mothers received intra-partum antibiotics as well as parents of children in the Neonatal Intensive Care Unit receiving systemic antibiotics during the first week of life will be offered to take part in the study (Groups A, B and C). Parents of children coming to a five day old check up at the Children's Hospital in Landspitali will also be offered to take part in the study (Group D). Sample size calculations show that to detect a 30% difference in immune responses to vaccines with 80% power, 40 infants are needed for analysis in each group. To account for late exclusions due to antibiotic use or drop-out due to other reasons, 50 infants will be recruited to each group. Participants will receive vaccination with the oral live attenuated rotavirus vaccine, Rotarix, at six weeks old and again at three months old. Participants will receive vaccinations with Pentavac against diphtheria, tetanus, pertussis, haemophilus influenza type B and polio and Synflorix against pneumococci at their Health Care Centre according to scheduled childhood vaccinations in Iceland at three, five and 12 months old. Salivary and blood samples will be taken from participants just before the first vaccination with Rotarix at six weeks old and again at six months (four weeks after the second dose of Pentavac and Synflorix) and at 13 months old (four weeks after the third dose of Pentavac and Synflorix). Specific antibody levels against rotavirus, pertussis, diphtheria, tetanus, haemophilus influenzae type B, polio virus and pneumococci will be measured. Parents of participants will be given two stool sample kits and asked to take one from their child at six weeks old (before the first dose of rotavirus vaccine) and then another at three months old. In case of detection of differences in antibody response, these samples will be sent for microbiome analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

Inclusion Criteria:

• All term children born in Iceland from 2022-2023

Exclusion Criteria:

• Children born with emergency caesarean section

• Children born before 36 weeks of gestation

• Children diagnosed with primary or secondary immunodeficiency

• Use of immunosuppressive drugs at recruitment or during the follow up period (excluding inhaled corticosteroids and short term oral corticosteroids (<3 consecutive days).

• Children with chromosomal, genetic or other congenital diseases or abnormalities

• Children with severe, chronic diseases or disabilities

• Informed consent not signed by parents

Related Conditions & MeSH terms

• Antibiotic Treatment
• Immune Responses

Intervention

Other:
• Antibiotic treatment
Children will be assigned to groups according to antibiotic exposure in early life. No antibiotics will be given in the study.

Locations

Country	Name	City	State
Iceland	Landspitali University Hospital	Reykjavík

Sponsors (1)

Lead Sponsor	Collaborator
Landspitali University Hospital

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum antibody response to rotavirus	Serum IgA against rotavirus	2 years
Primary	Salivary antibody response to rotavirus	Salivary IgA levels against rotavirus	2 years
Primary	Serum antibody response to other microbes	Serum IgG against other microbes	2 years
Primary	Salivary antibody response to other microbes	Salivary IgG against other microbes	2 years
Secondary	Composition of the microbiome	16s rRNA analysis of stool microbiome	3 years