Vaccine Immunity and Inflammation in the Aging Person Living With HIV
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHennepin Healthcare Research Institute
About this trial
This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions (in this study - HIV) and with age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age>=18 years
HIV Diagnosis
On Antiretroviral Therapy with HIV Viral Load<200 within last year
Disqualifiers
Other significant immunosuppressing condition
Age< 18 years
Pregnancy (at enrollment)
Contraindication to pneumococcal vaccination
Trial design
Design model
Single group
Treatments tested in this trial
Conjugate Pneumococcal Vaccine 20 (PCV20)
Biological/VaccineVaccine
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Pneumococcal VaccinationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary objective
Evaluate the impact of HIV status on pneumococcal vaccine immunogenicity and durability as measured pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at an acute (primary comparison) and memory (secondary comparison) post-vaccination timepoints.
Time frame
30 days and 2 yearsSecondary outcomes
1
Secondary objective
Explore the impact of advanced age on pneumococcal vaccine immunogenicity and durability in PLWH. This will be evaluated by evaluating the relationship of age and pneumococcal-specific Ab concentration, memory B cell responses (frequency and phenotype) and CD4 T cell responses (frequency and phenotype) at acute and memory timepoints.
Time frame
30 days and 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hennepin Healthcare Research Institute
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov