N/A
Completed N=302
The Interaction Between Measles and DTP Vaccination
Non-target Heterologous Effects of Vaccines · Vaccine Interactions
Source: ClinicalTrials.gov NCT02710045 ↗
Enrolled (actual)
302
Serious AEs
0.3%
Results posted
Jan 2019
Primary outcomePrimary: Effect on Interferon (IFN)-Gamma : Interleukin (IL)-4 Ratio in Plasma — 1.48; 1.44; 0.46 ratio of cytokines in pg/mL
Summary
The purpose of this study is to investigate for the broad immunological effects of administering measles vaccine (MV) and diphtheria-tetanus-whole cell pertussis vaccine (DTP) to 9 month old Gambian infants, either alone or together. Effects on vaccine-specific immune responses, innate immunity, and immune memory were studied. The hypothesis is that when MV and DTP are given together there will be more inflammation and this will interfere with generation of immunity to the vaccine and to other non-vaccine related stimuli.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect on Interferon (IFN)-Gamma : Interleukin (IL)-4 Ratio in Plasma |
1.48; 1.44; 0.46 | — |
| PRIMARY Effect on CD4+FOXP3+CD127- Regulatory T Cell Frequencies |
5.84; 4.94; 5.86; 6.71; 5.38; 4.85 | — |
| SECONDARY Effect of Vaccine Group on Measles Antibody Levels |
0.29; 0.21; 0.3; 5.28; 5.52; 0.37 | — |
| SECONDARY Effect of Vaccine Group on Effector Memory T Cells (TEM) |
3.54; 2.67; 3.10; 4.50; 5.27; 4.52 | — |
| SECONDARY Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels |
0.62; 0.80; 0.86; 0.87; 5.45; 6.46 | — |
| SECONDARY Effect of Vaccine Group on Pertussis Toxoid Antibody Levels |
18.30; 10.68; 11.11; 18.91; 103.72; 86.96 | — |
| SECONDARY Measles Antibody Levels at 19 Months of Age |
7.74; 7.47; 7.69 | — |
Eligibility Criteria
- Inclusion Criteria:
- Healthy 4 month old infants
- All EPI vaccines received to date according to current Gambia government schedule
- Normal weight for age according to growth chart
- Exclusion Criteria:
- Temperature >37.5°C
- Any history of ongoing chronic illness
Data sourced from ClinicalTrials.gov (NCT02710045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.