The Effects of Antibiotic Exposure in Early Infancy on Vaccine Responses

NCT06079606 | Active Not Recruiting

• 1 other identifier: e-INFANT-2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune Responses; Antibiotic Treatment

Keywords

Antibiotics; Immune Responses; Vaccinations; Children; Rotavirus

Outcome Measures

Primary Outcomes (4)

• Serum antibody response to rotavirus

  Serum IgA against rotavirus

  2 years

• Salivary antibody response to rotavirus

  Salivary IgA levels against rotavirus

  2 years

• Serum antibody response to other microbes

  Serum IgG against other microbes

  2 years

• Salivary antibody response to other microbes

  Salivary IgG against other microbes

  2 years

Secondary Outcomes (1)

• Composition of the microbiome

  3 years

Study Arms (4)

Group A

Term children born with caesarean section (their mothers received intra-operative antibiotics)

Other: Antibiotic treatment

Group B

Term vaginally born children and their mothers received intra-partum antibiotics

Other: Antibiotic treatment

Group C

Term vaginally born children that received systemic antibiotics during the first week of life for at least 48 hours

Other: Antibiotic treatment

Group D (Control group)

Term vaginally born children that had not received systemic antibiotics at the time of recruitment

Interventions

Antibiotic treatment OTHER

Children will be assigned to groups according to antibiotic exposure in early life. No antibiotics will be given in the study.

Group A; Group B; Group C

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

* Group A: In total 50 term children born in Iceland during the time period 2022-2023, delivered with elective caesarean section (their mothers received intra-operative antibiotics). * Group B: In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and their mothers received intra-partum antibiotics. * Group C: In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and received systemic antibiotics during the first week of life for at least 48 hours. * Control group (Group D): In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and received no systemic antibiotics at the time of recruitment.

You may qualify if:

• All term children born in Iceland from 2022-2023

You may not qualify if:

• 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

Sponsors & Collaborators

• Landspitali University Hospital: lead

Study Sites (1)

Landspitali University Hospital

Reykjavik, 101, Iceland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and salivary samples collected for measurement of immune responses. Stool samples collected for microbiome analysis.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: September 10, 2022
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)