N/A
N=350,399
A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV
HIV · Pneumonia · Infections, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT05794191 ↗Enrolled (actual)
350,399
Serious AEs
—
Results posted
Oct 2025
Primary outcome: Primary: PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up — 167; 747 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vaccine Administration (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up |
167; 747 | — |
| PRIMARY VE for First Event of IPD at 0-3 Years of Follow-up |
73; 566 | — |
| PRIMARY VE for First Event of IPD at 3-5 Years of Follow-up |
59; 116 | — |
| PRIMARY VE for First Event of IPD at 5-7 Years of Follow-up |
32; 54 | — |
| PRIMARY PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up |
309; 1362 | — |
| PRIMARY VE for First Event of PP at 0-3 Years of Follow-up |
161; 1092 | — |
| PRIMARY VE for First Event of PP at 3-5 Years of Follow-up |
94; 184 | — |
| PRIMARY VE for First Event of PP at 5-7 Years of Follow-up |
49; 69 | — |
| PRIMARY PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up |
8098; 34498 | — |
| PRIMARY VE for First Event of ACP at 0-3 Years of Follow-up |
4543; 27984 | — |
| PRIMARY VE for First Event of ACP at 3-5 Years of Follow-up |
2079; 4437 | — |
| PRIMARY VE for First Event of ACP at 5-7 Years of Follow-up |
1200; 1757 | — |
| SECONDARY PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up |
3996; 24423; 1886; 3979; 1031; 1460 | — |
| SECONDARY PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up |
3980; 24302; 1881; 3970; 1030; 1461 | — |
Summary
The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV.
The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream.
All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13.
Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.
Eligibility Criteria
Inclusion Criteria
- HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days but no more than 730 days apart
- At least 18 years of age at the time of the first HIV-related code
- At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code
Exclusion Criteria
- Evidence of PCV13 vaccination before the first HIV-related code
Data sourced from ClinicalTrials.gov (NCT05794191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.