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Vaccine

HIV-seronegative for Pneumococcal Infections

N/A
Waitlist Available
Led By Edward N Janoff, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks -12, 0, 1, 8, 9, 16
Awards & highlights

Study Summary

Human Immunodeficiency Virus (HIV) infection is complicated by high rates of infections and cancers which are often the cause of death rather than the HIV/acquired immune deficiency syndrome (AIDS) virus itself. Treatment of HIV with antiretroviral medications has decreased the frequency of many complications by over 90%, but bacterial pneumonia remains extremely high. Current vaccines are not very effective in preventing these infections in patients with HIV infection. The investigators are studying the cells (B cells) that make antibodies to fight infection by binding to and killing bacteria. The goal is to understand how HIV impairs the ability of B cells to make antibodies in sufficient quantity and of sufficient quality to protect patients with HIV to learn how to enhance protection against these infections. The investigators also seek to understand the role of the bacteria (specifically Streptococcus pneumoniae) that normally live in the nose and throat in the development of pneumonia and other infections.

Eligible Conditions
  • Pneumococcal Infections
  • HIV/AIDS
  • Pneumococcal Vaccines

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks -12, 0, 1, 8, 9, 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks -12, 0, 1, 8, 9, 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AID and BCL-6 production
Antibody-secreting cells
B and T cell subsets
+1 more
Secondary outcome measures
S.pneumoniae colonization and nasopharyngeal microbiome
S.pneumoniae urine antigen positivity

Trial Design

2Treatment groups
Experimental Treatment
Group I: HIV-seronegativeExperimental Treatment1 Intervention
HIV-seronegative subjects will receive Prevnar (PCV-13) at week 0.
Group II: HIV-infectedExperimental Treatment2 Interventions
HIV-infected subjects will receive Prevnar (PCV-13) at week 0, and Pneumovax (PPSV-23) at week 8 per Advisory Committee on Immunization Practices (ACIP) guidelines.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,466 Total Patients Enrolled
1 Trials studying Pneumococcal Infections
959 Patients Enrolled for Pneumococcal Infections
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,177 Total Patients Enrolled
11 Trials studying Pneumococcal Infections
3,246 Patients Enrolled for Pneumococcal Infections
Edward N Janoff, MDPrincipal InvestigatorUniversity of Colorado-Denver, Denver VA Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025