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OpenTrials
Completed

NCT Number: NCT05794191

A Study To Learn About The Effects Of Pneumococcal Vaccine In 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.

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Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Infections, Pneumococcal Lung Diseases Pneumococcal Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaccine Administration

Biological

PCV13 administration

Primary outcomes

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

    Time frame: 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:[(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).

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

    Time frame: 0 to 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).

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

    Time frame: 3 to 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).

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

    Time frame: 5 to 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. PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up

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

    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).

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

    Time frame: 0 to 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).

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

    Time frame: 3 to 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).

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

    Time frame: 5 to 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).

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

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

    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).

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

    Time frame: 0 to 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).

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

    Time frame: 3 to 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).

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

    Time frame: 5 to 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.

Secondary outcomes

  1. 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

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

    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. Data for total number of participants with episodes of pneumococcal pneumonia or pneumonia with unspecified causes are 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).

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

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

    VE 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. Pneumonia with unspecified causes was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of pneumonia with unspecified causes are 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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV in the United States

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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