Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03039491
• Date of registration: 30/01/2017
• Prospective Registration: No
• Primary sponsor: Medical University of South Carolina
• Public title: Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults
• Scientific title: Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals
• Date of first enrolment: September 1, 2015
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03039491
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Maria A. Julia Westerink, MD
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:HIV+ 21-40 years of age HIV+ 50-65 years of age HIV- 50-65 years of age

-

Exclusion Criteria:

- Previous immunization with pneumococcal vaccine less than 5 years ago

- pregnancy and absence of contraceptive practice in women of childbearing age and
breast feeding

- known anaphylaxis, hypersensitivity to the pneumonia vaccine

- those who received blood products or gammaglobulin in last 3 months

- inability to comprehend or sihn informed consent

- Medications known to affect immune function (chemotherapy, an
angiotensin-converting-enzyme (ACE) inhibitors, corticosteroids, anti-TNFalpha agents)

- previous disease/present illness that may affect response to vaccination: previous
pneumococcal disease, removal of spleen, auto-immune disease, end stage renal disease
(ESRD) or end stage liver disease, cancer)

- significant (3x upper limit of normal) in complete blood count (CBC), chemistries,
immunoglobulin levels



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Aging

HIV Lipodystrophy

Intervention(s)

Biological: 13 valent conjugated pneumococcal vaccine

Biological: Pneumococcal polysaccharide vaccine 23 valent

Primary Outcome(s)

Antibody response [Time Frame: Change in ug/mL from day 0 to 30 days after receipt of PPV23]

opsonophagocytic antibody activity [Time Frame: Change in opsonophagocytic titer from day 0 to 30 days after receipt of PPV23]

Secondary Outcome(s)

Expression of BCMA on PPS-specific B cells [Time Frame: change from day 0 to day 7]

Serum interleukin-6 (IL-6) [Time Frame: Day 0]

Expression of BAFFR on PPS-specific B cells [Time Frame: change from day 56 to day 63]

Expression of BCMA on PPS-specific B cells [Time Frame: change from day 7 to day 63]

Serum BAFF [Time Frame: Day 0]

Serum IL-1(B) [Time Frame: Day 0]

Serum TNFalpha [Time Frame: Day 0]

Expression of CD21 on PPS-specific B cells [Time Frame: change from day 56 to day 63]

Expression of cluster of differentiation 21 (CD21) on PPS-specific B cells [Time Frame: change from day 0 to day 7]

Expression of TACI on PPS-specific B cells [Time Frame: change from day 56 to day 63]

Serum IL-10 [Time Frame: Day 0]

Serum APRIL [Time Frame: Day 0]

Serum IL-1(RA) [Time Frame: Day 0]

Expression of CD40 on PPS-specific B cells [Time Frame: change from day 56 to day 63]

Expression of TACI on PPS-specific B cells [Time Frame: change from day 0 to day 7]

Expression of BAFFR on PPS-specific B cells [Time Frame: change from day 0 to day 7]

Expression of CD40 on PPS-specific B cells [Time Frame: change from day 0 to day 7]

PPS-specific B cell phenotype [Time Frame: Change from day 0 to day 7 post-vaccination]

PPS-specific B cell phenotype [Time Frame: Change from day 56 to day 63 post-vaccination]

Serum IL-8 [Time Frame: Day 0]

Secondary ID(s)

MUSC vaccine study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors