A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV

Completed

• Conditions: HIV; Pneumonia; Infections, Pneumococcal
• Interventions: Biological: Vaccine Administration

• Registration Number: NCT05794191
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study Start: 2023-03-22
• Study First Posted: 2023-04-03
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. 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
2. At least 18 years of age at the time of the first HIV-related code
3. At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code

Exclusion Criteria

1. Evidence of PCV13 vaccination before the first HIV-related code

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons living with HIV (PLWH)	Vaccine Administration	Adults with HIV

Primary Outcome Measures

Name	Time	Method
Incidence of invasive pneumococcal disease	July,1 2014 - September 30, 2022 (duration of study)	Medical record for IPD diagnosed by ICD9 or ICD10 code
Incidence of pneumococcal pneumonia	July 1, 2014 - September 30, 2022 (duration of study)	Diagnosis of pneumococcal pneumonia by ICD9 / ICD10 code
Incidence of all cause pneumonia	July 1, 2014 - September 30, 2022 (duration of study)	Incidence of all cause pneumonia diagnosed by ICD9 - ICD10 code

Secondary Outcome Measures

Name	Time	Method
Incidence of pneumococcal pneumonia or unspecified pneumonia	July 1, 2014 - September 30, 2022 (timeframe of study)
Incidence of pneumonia of unspecified causes	July 1, 2014 - September 30, 2022 (timeframe of study)

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States