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

NCT05794191 | Completed Results FDA Drug

• 2 other identifiers: B1851217NCT05794191
• Study Type: observational
• Target: 350,399
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Pneumonia; Infections, Pneumococcal

Outcome Measures

Primary Outcomes (12)

• PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up

  VE:\[(1-hazard ratio (HR)\]\*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)\*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Diseases,9th revision, Clinical Modification(ICD-9-CM)or ICD-10-CM.Data for total number of participants with IPD is reported in descriptive and VE (IPTW\*IPCW+imbalanced variables) is reported in statistical section.PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

• VE for First Event of IPD at 0-3 Years of Follow-up

  VE: \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  0 to 3 years of follow up

• VE for First Event of IPD at 3-5 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  3 to 5 years of follow up

• VE for First Event of IPD at 5-7 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  5 to 7 years of follow up

• PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

• VE for First Event of PP at 0-3 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  0 to 3 years of follow up

• VE for First Event of PP at 3-5 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  3 to 5 years of follow up

• VE for First Event of PP at 5-7 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  5 to 7 years of follow up

• PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

• VE for First Event of ACP at 0-3 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  0 to 3 years of follow up

• VE for First Event of ACP at 3-5 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

  3 to 5 years of follow up

• VE for First Event of ACP at 5-7 Years of Follow-up

  Vaccine effectiveness was calculated as \[(1- hazard ratio (HR)\] \* 100 and was obtained from Cox-MSM after applying the IPT \*IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW\*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up.

  5 to 7 years of follow up

Secondary Outcomes (2)

• 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

  0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years)

• PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up

  0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years)

Study Arms (1)

Persons living with HIV (PLWH)

Adults with HIV

Biological: Vaccine Administration

Interventions

Vaccine Administration BIOLOGICAL

PCV13 administration

Persons living with HIV (PLWH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with HIV in a healthcare administrative database

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

MeSH Terms

Conditions

Pneumonia; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: March 22, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)