HIV/AIDS Clinical Trial
Official title:
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults in the Era of Highly Active Antiretroviral Therapy: Analysis Stratified by CD4 T-cell Count
Verified date | February 2019 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).
Status | Completed |
Enrollment | 70 |
Est. completion date | February 28, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HIV-infeted subjects who received antiretroviral therapy for = 4 weeks Exclusion Criteria: - a history of pneumococcal infection within the recent five years - previous pneumococcal vaccination - current opportunistic infections - known immunodeficiency other than HIV infection - coagulation disorders |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opsonophagocytic assay (OPA) titers for PCV13 | OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results | Outcome measure will be assessed at two points (baseline and 28 ± 7 days after vaccination). | |
Secondary | Frequency and duration of local and systemic adverse events | The safety profiles of co-administration of Fluad and PCV13 will be compared to those of single vaccination. | All participants will be followed until 4 weeks after vaccination |
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