Optimising diphtheria, tetanus toxoids and pertussis (DTP) immunity through infant immunisation schedules in Nepal Infections and Infestations
Conditions
Interventions
Participants will be recruited across 2 sites
at Patan Hospital and the Tribhuvan University Teaching Hospital (TUTH), both in Kathmandu. Recruitment and randomisation will take place at the time of attendance for the child’s 6-week immunisations
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
42 Days to 50 Days
Inclusion criteria
Inclusion criteria: 1. Age of 42 - 50 days old at time of first visit 2. Generally healthy as determined by a medical history and examination 3. Resident in the Kathmandu Valley, Nepal study area and planning to remain in the study area for the 2 years of the study
Exclusion criteria
Exclusion criteria: 1. Born at less than 36 weeks gestation 2. Birth weight <2.5 kg, or a current weight of <3 kg at 6 weeks of age, as determined by a medical professional 3. Prior receipt of any vaccination except Polio, Hepatitis B, or BCG 4. Planned administration of vaccines other than the study vaccines (with the exception of vaccines against rotavirus, hepatitis A & B, inactivated influenza and varicella, which can be administered 14 days before or after study vaccines; polio and measles/rubella vaccines as part of national campaigns; and BCG vaccines which will be administered when indicated by national programme) 5. Parents who plan to move out of the geographical study area 6. Concurrently participating in another clinical study, which includes blood draws or IMPs, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device) 7. Any major congenital defects, serious chronic illness, significant disease, disorder, family history or diagnosis of immunosuppressive condition, or medical treatments which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study 8. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period; Known allergy to any vaccine components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pertussis IgG immune response measured in Multiplexed Immune Assay (MIA)-5 plex at the pre-booster dose time point, i.e. at age 9 or 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/06/2024: 1. Pertussis IgG immune response measured in an MIA 4-plex at the post-prime dose time point, (i.e. at age 10, 12, 14 or 16 weeks), 1-month post-primary series (i.e. age 18, 20, or 28 weeks), pre-booster timepoint (i.e. at age 9 or 12 months), post-booster timepoint (i.e. at age 10 or 13 months) and at age 24 months. 2. Diphtheria IgG immune response measured on an MIA 5-plex using in-house reference sera calibrated against the WHO standard, at age 14 or 16 weeks, 1-month post-primary series (i.e. age 18, 20, or 28 weeks), pre-booster timepoint (i.e. at age 9 or 12 months), post-booster timepoint (i.e. at age 10 or 13 months) and at age 24 months. The MIA 5-plex uses in-house reference sera as standard, which are calibrated against the WHO standard (van Gageldonk et al.,2008; van Gageldonk et al., 2011) 3. Tetanus IgG immune response measured on an MIA 5-plex using in-house reference sera calibrated against the WHO standard, at age 14 or 16 weeks, 1-month post-primary series (i.e. age 18, 20, or 28 weeks), pre-booster timepoint (i.e. at age 9 or 12 months), post-booster timepoint (i.e. at age 10 or 13 months) and at age 24 months 4. Hep B virus S antigen, mIU/ml measured using an assay currently under development at the Dutch Institute of Public Health, at age 14 or 16 weeks, 1-month post-primary series (i.e. age 18, 20, or 28 weeks), pre-booster timepoint (i.e. at age 9 or 12 months), post-booster timepoint (i.e. at age 10 or 13 months) and at age 24 months 5. PRP (Hib) IgG immune response measured using a multiplexed immune assay, at age 14 or 16 weeks, 1-month post-primary series (i.e. age 18, 20, or 28 weeks), pre-booster timepoint (i.e. at age 9 or 12 months), post-booster timepoint (i.e. at age 10 or 13 months) and at age 24 months. 6. Serotype specific anti-pneumococcal IgG measured in an MIA x-plex in 1a, 2, 3 and 4 blood samples in all arms and booster groups. IVIG that has been calibrated against the 8 | — |
Countries
Nepal
Contacts
Public ContactSarah Kelly
Outcome results
None listed