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

Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; HIV; Infections, Pneumococcal
• Intervention / Treatment: Biological: Vaccine Administration

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Recruiting
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with HIV in a healthcare administrative database

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons living with HIV (PLWH); Adults with HIV	Biological: Vaccine Administration; PCV13 administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: B1851217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No