Diphtheria, Pneumococcal Infections, Tetanus
Conditions
Brief summary
When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.
Detailed description
Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).
Interventions
BIOLOGICALTetanus-diphtheria (Td) and PCV13
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
BIOLOGICALPCV13 alone
154 PCV13 recipients: one vaccine injection administered on Day 0
BIOLOGICALTd alone
437 Td recipients: one vaccine injection administered on Day 0
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged ≥50 years who signed the informed consent
Exclusion criteria
* history of S. pneumoniae infection within the previous 5 years * previous pneumococcal vaccination * previous tetanus-diphtheria (Td) vaccination within the last 10 years * known immunodeficiency or immunosuppressant use or coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tetanus antibody titers at day 28 post-vaccination | 4 weeks after vaccination | IgG antibody titers by enzyme linked immunosorbent assay (ELISA) Seroprotection rate: percentage of subjects with a post-vaccination antibody levels ≥0.1 IU/mL |
| Diphtheria antibody titers at day 28 post-vaccination | 4 weeks after vaccination | IgG antibody titers by enzyme linked immunosorbent assay (ELISA) |
| Tetanus seroprotection rate at day 28 post-vaccination | 4 weeks after vaccination | Proportion of IgG antibody titers ≥0.1 IU/mL |
| Diphtheria seroprotection rate at day 28 post-vaccination | 4 weeks after vaccination | Proportion of IgG antibody titers ≥0.1 IU/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opsonophagocytic assay (OPA) titers for PCV13 | 4 weeks after vaccination | Four capsule serotypes: 1, 5, 18C and 19A |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency and duration of local and systemic adverse events | During 4 weeks after vaccination | The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination. |
Outcome results
None listed