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

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05794191
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV; Pneumonia; Infections, Pneumococcal	Biological: Vaccine Administration

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Assessment Of 13-Valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of invasive pneumococcal disease [July,1 2014 - September 30, 2022 (duration of study)]

   Medical record for IPD diagnosed by ICD9 or ICD10 code

2. Incidence of all cause pneumonia [July 1, 2014 - September 30, 2022 (duration of study)]

   Incidence of all cause pneumonia diagnosed by ICD9 - ICD10 code

3. Incidence of pneumococcal pneumonia [July 1, 2014 - September 30, 2022 (duration of study)]

   Diagnosis of pneumococcal pneumonia by ICD9 / ICD10 code

Secondary Outcome Measures

1. Incidence of pneumococcal pneumonia or unspecified pneumonia [July 1, 2014 - September 30, 2022 (timeframe of study)]

2. Incidence of pneumonia of unspecified causes [July 1, 2014 - September 30, 2022 (timeframe of study)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. HIV infection defined as at least one inpatient or ≥2 outpatient codes related to HIV at least 30 days

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 prior to the first HIV-related code

Exclusion Criteria:

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

2. Evidence of antiretroviral therapy (ART) usage before the first HIV-related code among adults with HIV whose index date is on or after January 1, 2015.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer	New York	New York	United States	10017

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05794191
• Other Study ID Numbers: B1851217
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pneumococcal Infections

Study Results

No Results Posted as of Apr 3, 2023