Skip to content

A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age

This study will evaluate the immune response to the MMRVNS vaccines (formulated with different potencies) and the MMRV vaccine (pooled group) in terms of GMCs for antibodies to measles, mumps, rubella, and varicella viruses.

Read more

Safety of Tetanus, Diphtheria, Acellular Pertussis with 5 Acellular Pertussis Components (Tdap5) Vaccination during Pregnancy: A Cohort Study using US Electronic Health Record Data

The primary objective of this study is to further evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel during the third trimester of pregnancy and their offspring with regards to pre-defined pregnancy, birth, and neonatal outcomes.

Read more

Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) vs High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4) for Prevention of Lab-confirmed Influenza Medical Encounters

In this study, each objective will be evaluated for each season individually and in a combined analysis. The primary objective is to assess the relative vaccine effectiveness of aIIV4 vs HD-IIV4 for prevention of polymerase-chain reaction (PCR) confirmed influenza. The…

Read more

Prevalence of Self-Inflicted Injuries Among Transgender and Gender Diverse Adolescents and Young Adults Compared to Their Peers: An Examination of Interaction with Mental Health Morbidity

Compare occurrence of self-inflicted injuries among transgender and gender diverse (TGD) youth to that of their cisgender peers while accounting for mental health diagnoses. Review of electronic health records from three integrated health care systems identified 1087 transfeminine and 1431…

Read more

Age group differences in substance use, social support, and physical and mental health concerns among people living with HIV two years after receiving primary care-based alcohol treatment

Objectives: People living with HIV (PWH) have seen reduction in HIV-associated morbidity and increase in near-normal life expectancy, yet unhealthy alcohol use poses substantial risks to older as well as younger adults. Further research regarding age-associated physical and mental health…

Read more

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022

During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…

Read more

COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion

In the Vaccine Safety Datalink (VSD), we previously reported no association between COVID-19 vaccination in early pregnancy and spontaneous abortion (SAB). The current study aims to understand how time since vaccine roll-out or other methodologic factors could affect results. Using…

Read more

Human Immunodeficiency Virus Status, Tenofovir Exposure, and the Risk of Poor Coronavirus Disease 19 (COVID-19) Outcomes: Real-World Analysis From 6 United States Cohorts Before Vaccine Rollout

People with human immunodeficiency virus (HIV) (PWH) may be at increased risk for severe coronavirus disease 2019 (COVID-19) outcomes. We examined HIV status and COVID-19 severity, and whether tenofovir, used by PWH for HIV treatment and people without HIV (PWoH)…

Read more

Effect of adopting the new race-free 2021 CKD-EPI eGFR creatinine equation on racial differences in kidney disease progression among people with HIV; an observational study

The impact of adopting a race-free estimated glomerular filtration rate (eGFR) creatinine (eGFRcr) equation on racial differences in chronic kidney disease (CKD) progression among people with human immunodeficiency virus (PWH) is unknown. We defined eGFR stages using the original race-adjusted…

Read more

Vaccine effectiveness against influenza-associated urgent care, emergency department, and hospital encounters during the 2021-2022 season, VISION Network

Following historically low influenza activity during the 2020-2021 season, the United States saw an increase in influenza circulating during the 2021-2022 season. Most viruses belonged to the influenza A(H3N2) 3C.2a1b 2a.2 subclade. We conducted a test-negative case-control analysis among adults…

Read more

Association of Race and Ethnicity With Initial Prescription of Antiretroviral Therapy Among People With HIV in the US

Integrase strand transfer inhibitor (INSTI)-containing antiretroviral therapy (ART) is currently the guideline-recommended first-line treatment for HIV. Delayed prescription of INSTI-containing ART may amplify differences and inequities in health outcomes. To estimate racial and ethnic differences in the prescription of INSTI-containing…

Read more

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022

During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…

Read more

Impact of the Coronavirus Disease 2019 Pandemic on Antiretroviral Therapy Initiation and Care Delivery for People With Newly Diagnosed HIV in an Integrated Healthcare System

The coronavirus disease 2019 (COVID-19) pandemic disrupted health systems. For patients newly diagnosed with human immunodeficiency virus, starting immediate antiretroviral therapy (ART) is recommended. For periods before and during the COVID-19 pandemic, Kaiser Permanente Northern California found similar rates of…

Read more

Kaiser PrEP data

The purpose of this study is to initiate a 5-year collaboration between the Centers for Disease Control and Prevention (CDC) and 3 KP regions (KPNC, KPSC and KPMAS) to include PrEP prescription data and key demographics in the U.S. Department…

Read more

VSD Infrastructure

We conduct administrative tasks, data management, and contribute to vaccine safety assessments to support the management and development of the ongoing work of the VSD. This includes producing and maintaining a high-quality electronic data infrastructure encompassing health plan members of…

Read more

Retrospective cohort study to assess the association between treatment with tocilizumab and mortality among mechanically ventilated patients with COVID-19

Assess the association between tocilizumab administration and clinical outcomes among mechanically ventilated patients with COVID-19 pneumonia. Retrospective cohort study. Large integrated health system with 9 million members in California, USA. 4185 Kaiser Permanente members hospitalised with COVID-19 pneumonia requiring invasive mechanical…

Read more

Prescribing for different antibiotic classes across age groups in the Kaiser Permanente Northern California population in association with influenza incidence, 2010-2018

There is limited information on the volume of antibiotic prescribing that is influenza-associated, resulting from influenza infections and their complications (such as streptococcal pharyngitis). We estimated that for the Kaiser Permanente Northern California population during 2010-2018, 3.4% (2.8%-4%) of all…

Read more

Effectiveness of COVID-19 mRNA Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults During SARS-CoV-2 Omicron Predominance – VISION Network, 10 States, December 2021-August 2022

Persons with moderate-to-severe immunocompromising conditions might have reduced protection after COVID-19 vaccination, compared with persons without immunocompromising conditions (1-3). On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended that adults with immunocompromising conditions receive an expanded primary…

Read more

Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States

Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine effectiveness (VE) are needed. To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during…

Read more

CEIP Post COVID Fatiguing Illness

This study aims to identify and characterize persons who are at risk of developing or who have developed post-COVID conditions, including those with medically unexplained illness in certain risk groups, and identify risk factors for post-COVID conditions.

Read more

Toward Ending the HIV Epidemic: Temporal Trends and Disparities in Early ART Initiation and Early Viral Suppression Among People Newly Entering HIV Care in the United States, 2012-2018

In 2012, the US Department of Health and Human Services updated their HIV treatment guidelines to recommend antiretroviral therapy (ART) for all people with HIV (PWH) regardless of CD4 count. We investigated recent trends and disparities in early receipt of…

Read more

Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated – VISION Network, 10 States, December 2021-June 2022

The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in the United States in November 2021, with the BA.1 sublineage (including BA.1.1) causing the largest surge in COVID-19 cases to date. Omicron sublineages BA.2 and…

Read more

Risk of severe clinical outcomes among persons with SARS-CoV-2 infection with differing levels of vaccination during widespread Omicron (B.1.1.529) and Delta (B.1.617.2) variant circulation in Northern California: A retrospective cohort study

The incidence of and risk factors for severe clinical outcomes with the Omicron (B.1.1.529) SARS-CoV-2 variant have not been well-defined. We conducted a retrospective cohort study to assess risks of severe clinical outcomes within 21 days after SARS-CoV-2 diagnosis in…

Read more

Mission, Organization, and Future Direction of the Serological Sciences Network for COVID-19 (SeroNet) Epidemiologic Cohort Studies

Global efforts are needed to elucidate the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the underlying cause of coronavirus disease 2019 (COVID-19), including seroprevalence, risk factors, and long-term sequelae, as well as immune responses after vaccination across populations…

Read more

Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults – VISION Network, 10 States, December 2021-March 2022

CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a…

Read more

Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years – VISION Network, 10 States, April 2021-January 2022

The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17…

Read more

Incidence and Estimated Vaccine Effectiveness Against Hospitalizations for All-Cause Pneumonia Among Older US Adults Who Were Vaccinated and Not Vaccinated With 13-Valent Pneumococcal Conjugate Vaccine

Following routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in children in 2010, invasive pneumococcal disease rates have decreased substantially in children and adults. In 2014, the Advisory Committee for Immunization Practices recommended routine use of PCV13 among adults aged…

Read more

Antibiotic prescribing across age groups in the Kaiser Permanente Northern California population in association with different diagnoses, and with influenza incidence, 2010-2018

There is limited information on the volume of antibiotic prescribing that is influenza-associated, resulting from influenza infections and their complications (such as streptococcal pharyngitis and otitis media). Here, we estimated age/diagnosis-specific proportions of antibiotic prescriptions (fills) for the Kaiser Permanente…

Read more

Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022

CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after…

Read more

Do contemporary antiretrovirals increase the risk of end-stage liver disease? Signals from patients starting therapy in the North American AIDS Cohort Collaboration on Research and Design

Despite effective antiretroviral therapy, rates of end-stage liver disease (ESLD) remain high. It is not clear whether contemporary antiretrovirals contribute to the risk of ESLD. We included patients from cohorts with validated ESLD data in the North American AIDS Cohort…

Read more

Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study

Recombinant influenza vaccine (RIV) has been in use in US adults since 2013. This study evaluated the safety of quadrivalent recombinant influenza vaccine (RIV4, Flublok® Quadrivalent, Sanofi Pasteur) compared with standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in self-identified Chinese adults…

Read more

Effectiveness of a Third Dose of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022

Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because of waning vaccine induced immunity over time,* possible increased immune evasion by SARS-CoV-2 variants (3), or a combination of these and other factors. CDC recommends that…

Read more

Development and validation of a prediction algorithm to identify birth in countries with high tuberculosis incidence in two large California health systems

Though targeted testing for latent tuberculosis infection ("LTBI") for persons born in countries with high tuberculosis incidence ("HTBIC") is recommended in health care settings, this information is not routinely recorded in the electronic health record ("EHR"). We develop and validate…

Read more

Contributions of COVID-19 Pandemic-Related Stressors to Racial and Ethnic Disparities in Mental Health During Pregnancy

This study aimed to identify racial and ethnic disparities in prenatal mental health and identify COVID-19 pandemic-related health/healthcare and economic contributors to these disparities, using an established framework for disparity investigation. This cross-sectional study includes 10,930 pregnant people at Kaiser…

Read more

Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink

The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their association with childhood vaccination coverage are unclear. To compare trends in pediatric vaccination before and during the pandemic and to…

Read more

Laboratory-Confirmed COVID-19 Among Adults Hospitalized with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity – Nine States, January-September 2021

Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared…

Read more

Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults – Nine States, January-September 2021

Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately 3% of the U.S. adult population (1). Immunocompromised adults are at increased risk for severe COVID-19 outcomes (2) and might…

Read more

Tuberculosis Epidemiologic Studies Consortium III

This study will identify primary care systems and settings that serve non-U.S.-born persons at risk for latent tuberculosis infection (LTBI) and tuberculosis disease; collect retrospective and prospective electronic medical record data; design and implement clinical care-based interventions to improve performance…

Read more

COVID-19 Vaccination and Non-COVID-19 Mortality Risk – Seven Integrated Health Care Organizations, United States, December 14, 2020-July 31, 2021

By September 21, 2021, an estimated 182 million persons in the United States were fully vaccinated against COVID-19.* Clinical trials indicate that Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Johnson & Johnson; Ad.26.COV2.S) vaccines are effective and generally well tolerated (1-3).…

Read more

The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine

Efficacy of the live-attenuated herpes zoster (HZ) vaccine (ZVL) wanes substantially over time. We evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) in previous ZVL recipients. Adults aged ≥65 years who were previously vaccinated with ZVL ≥5 years earlier…

Read more

Clinical effectiveness of integrase strand transfer inhibitor-based antiretroviral regimens among adults with human immunodeficiency virus: a collaboration of cohort studies in the United States and Canada

Integrase strand transfer inhibitor (InSTI)-based regimens are now recommended as first-line antiretroviral therapy (ART) for adults with human immunodeficiency virus, but evidence on long-term clinical effectiveness of InSTI-based regimens remains limited. We examined whether InSTI-based regimens improved longer-term clinical outcomes.…

Read more

Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19-Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance – Nine States, June-August 2021

Data on COVID-19 vaccine effectiveness (VE) since the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, became the predominant circulating strain in the United States are limited (1-3). CDC used the VISION Network* to examine medical encounters (32,867)…

Read more

A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age

Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes not in PCV13 continue to present a substantial disease burden. The 20-valent PCV (PCV20) was developed to expand protection against…

Read more

Current and Past Immunodeficiency Are Associated With Higher Hospitalization Rates Among Persons on Virologically Suppressive Antiretroviral Therapy for up to 11 Years

Persons with human immunodeficiency virus (PWH) with persistently low CD4 counts despite efficacious antiretroviral therapy could have higher hospitalization risk. In 6 US and Canadian clinical cohorts, PWH with virologic suppression for ≥1 year in 2005-2015 were followed until virologic…

Read more

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices – United States, July 2021

In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the…

Read more

A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year-Old Boys and Girls Compared with a Standard 3-dose

This study will evaluate extended 2-dose regimens in boys and girls ages 10 to 15 who previously received 1 dose of 9vHPV vaccine and did not complete the series and in HPV vaccine-naive boys and girls ages 9 to 14.…

Read more

COVID-19 Vaccination Coverage Among Insured Persons Aged ≥16 Years, by Race/Ethnicity and Other Selected Characteristics – Eight Integrated Health Care Organizations, United States, December 14, 2020-May 15, 2021

COVID-19 vaccination is critical to ending the COVID-19 pandemic. Members of minority racial and ethnic groups have experienced disproportionate COVID-19-associated morbidity and mortality (1); however, COVID-19 vaccination coverage is lower in these groups (2). CDC used data from CDC's Vaccine…

Read more

Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

This is a Brighton Collaboration Case Definition of the term "Multisystem Inflammatory Syndrome in Children and Adults (MIS-C/A)" to be utilized in the evaluation of adverse events following immunization. The case definition was developed by topic experts convened by the…

Read more

Rationale and Design of the Pragmatic Randomized Trial of Icosapent Ethyl for High Cardiovascular Risk Adults (MITIGATE)

The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD). IPE is…

Read more

Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial

In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV…

Read more

Current and Past Immunodeficiency are Associated with Higher Hospitalization Rates among Persons on Virologically Suppressive Antiretroviral Therapy for up to Eleven Years

Persons with HIV (PWH) with persistently low CD4 counts despite efficacious antiretroviral therapy could have higher hospitalization risk. In six US and Canadian clinical cohorts, PWH with virologic suppression for ≥1 year in 2005-2015 were followed until virologic failure, loss…

Read more

Shouting at each other into the void: A linguistic network analysis of vaccine hesitance and support in online discourse regarding California law SB277

In 2015, California passed Senate Bill 277 and became the third state in the United States to ban all nonmedical exemptions from school immunization requirements, effectively prohibiting religious and personal belief exemptions. This attracted grassroots opposition and considerable debate among…

Read more

Identification and description of mumps cases in a non-outbreak setting and evaluation of the effectiveness of mumps-containing vaccines over time

Mumps outbreaks among previously vaccinated young adults raise concerns regarding waning vaccine immunity. This study identified, described and assessed the changing incidence of mumps cases following mumps-containing vaccination (MMR/MMRV) in a non-mumps outbreak setting. Potential cases between 1996 and 2018…

Read more

Health care utilization and HIV clinical outcomes among newly enrolled patients following Affordable Care Act implementation in a California integrated health system: a longitudinal study

The Affordable Care Act (ACA) has increased insurance coverage for people with HIV (PWH) in the United States. To inform health policy, it is useful to investigate how enrollment through ACA Exchanges, deductible levels, and demographic factors are associated with…

Read more

SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics – Eight U.S. Health Care Centers, March 1-May 30, 2020

Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19), possibly related to changes in their immune system and respiratory physiology* (1). Further, adverse birth outcomes, such as preterm delivery and stillbirth, might be more common among…

Read more

Obesity and Mortality Among Patients Diagnosed With COVID-19: Results From an Integrated Health Care Organization

Obesity, race/ethnicity, and other correlated characteristics have emerged as high-profile risk factors for adverse coronavirus disease 2019 (COVID-19)-associated outcomes, yet studies have not adequately disentangled their effects. To determine the adjusted effect of body mass index (BMI), associated comorbidities, time,…

Read more

Sensorineural hearing loss (SNHL) as an adverse event following immunization (AEFI): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

This is a Brighton Collaboration case definition of the term "Sensorineural Hearing Loss" to be utilized in the evaluation of adverse events following immunization. The case definition was developed by a group of experts convened by the Coalition for Epidemic…

Read more

Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data

In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with…

Read more

Epidemiology and clinical outcomes of hospitalizations for acute respiratory or febrile illness and laboratory-confirmed influenza among pregnant women during six influenza seasons, 2010-2016

Pregnant women are at increased risk of seasonal influenza hospitalizations, but data about the epidemiology of severe influenza among pregnant women remain largely limited to pandemics. To describe the epidemiology of hospitalizations for acute respiratory infection or febrile illness (ARFI)…

Read more

Evaluating screening participation, follow-up and outcomes for breast, cervical and colorectal cancer in the PROSPR consortium

Cancer screening is a complex process encompassing risk assessment, the initial screening examination, diagnostic evaluation, and treatment of cancer precursors or early cancers. Metrics that enable comparisons across different screening targets are needed. We present population-based screening metrics for breast,…

Read more

Homeschooling parents in California: Attitudes, beliefs and behaviors associated with child’s vaccination status

Senate Bill 277 (SB277) banned nonmedical exemptions from school-entry vaccination requirements for children attending classroom-based schools in California, but excluded homeschooled children from vaccination requirements. Thus, it was hypothesized that more parents would choose to homeschool to avoid vaccination requirements…

Read more

Background rates of maternal, fetal, neonatal, and infant outcomes and events of interest to inform maternal immunization clinical trials

GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in…

Read more

LIFE EXPECTANCY DISPARITIES AMONG ADULTS WITH HIV IN THE UNITED STATES AND CANADA: THE IMPACT OF A REDUCTION IN DRUG- AND ALCOHOL-RELATED DEATHS USING THE LIVES SAVED SIMULATION (LISSO) MODEL

Improvements in life expectancy among people living with human immunodeficiency virus (PLWH) receiving antiretroviral treatment in the United States and Canada might differ among key populations. Given the difference in substance use among key populations and the current opioid epidemic,…

Read more

Prevalence of human papillomavirus (HPV)-vaccine types by race/ethnicity and sociodemographic factors in women with high-grade cervical intraepithelial neoplasia (CIN2/3/AIS), Alameda County, California, United States

We evaluated racial/ethnic differences in prevalence of oncogenic HPV types targeted by the quadrivalent HPV vaccine (16/18) and nonavalent HPV vaccine (31/33/45/52/58) in women diagnosed with CIN2/3/AIS after quadrivalent HPV vaccine introduction (2008-2015). Typing data from 1810 cervical tissue specimen…

Read more

Implementing electronic substance use disorder and depression and anxiety screening and behavioral interventions in primary care clinics serving people with HIV: Protocol for the Promoting Access to Care Engagement (PACE) trial

Substance use disorders (SUDs) and psychiatric disorders are common among people with HIV (PWH) and lead to poor outcomes. Yet these conditions often go unrecognized and untreated in primary care. The Promoting Access to Care Engagement (PACE) trial currently in…

Read more

The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial

Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and…

Read more

Influenza Vaccine Effectiveness in Preventing Influenza-associated Hospitalizations During Pregnancy: A Multi-country Retrospective Test Negative Design Study, 2010-2016

To date, no study has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy. The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) consisted of public health or healthcare systems with integrated laboratory, medical, and vaccination records in Australia, Canada…

Read more

Comparison of msp genotyping and a 24 SNP molecular assay for differentiating Plasmodium falciparum recrudescence from reinfection

Current World Health Organization guidelines for conducting anti-malarial drug efficacy clinical trials recommend genotyping Plasmodium falciparum genes msp1 and msp2 to distinguish recrudescence from reinfection. A more recently developed potential alternative to this method is a molecular genotyping assay based…

Read more

One Size Fits (n)One: The Influence of Sex, Age, and Sexual Human Immunodeficiency Virus (HIV) Acquisition Risk on Racial/Ethnic Disparities in the HIV Care Continuum in the United States

The United States National HIV/AIDS Strategy established goals to reduce disparities in retention in human immunodeficiency virus (HIV) care, antiretroviral therapy (ART) use, and viral suppression. The impact of sex, age, and sexual HIV acquisition risk (ie, heterosexual vs same-sex…

Read more

Contributions of traditional and HIV-related risk factors on non-AIDS-defining cancer, myocardial infarction, and end-stage liver and renal diseases in adults with HIV in the USA and Canada: a collaboration of cohort studies

Adults with HIV have an increased burden of non-AIDS-defining cancers, myocardial infarction, end-stage liver disease, and end-stage renal disease. The objective of this study was to estimate the population attributable fractions (PAFs) of preventable or modifiable HIV-related and traditional risk…

Read more

Exploring California’s new law eliminating personal belief exemptions to childhood vaccines and vaccine decision-making among homeschooling mothers in California

California's Senate Bill 277 (SB-277) law eliminated the personal belief exemption to school immunization requirements. A potential consequence may be that parents choose homeschooling to avoid immunization. Vaccine attitudes and behaviors have not been well studied among the home-schooling population.…

Read more

Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses…

Read more

Healthcare Effectiveness Data and Information Set (HEDIS) measures of alcohol and drug treatment initiation and engagement among people living with the human immunodeficiency virus (HIV) and patients without an HIV diagnosis

Background: Problematic use of alcohol and other drugs (AOD) is highly prevalent among people living with the human immunodeficiency virus (PLWH), and untreated AOD use disorders have particularly detrimental effects on human immunodeficiency virus (HIV) outcomes. The Healthcare Effectiveness Data…

Read more

Patient characteristics associated with treatment initiation and engagement among individuals diagnosed with alcohol and other drug use disorders in emergency department and primary care settings

Background: Treatment initiation and engagement rates for alcohol and other drug (AOD) use disorders differ depending on where the AOD use disorder was identified. Emergency department (ED) and primary care (PC) are 2 common settings where patients are identified; however,…

Read more

The association between medical comorbidity and Healthcare Effectiveness Data and Information Set (HEDIS) measures of treatment initiation and engagement for alcohol and other drug use disorders

Background: Medical comorbidity may influence treatment initiation and engagement for alcohol and other drug (AOD) use disorders. We examined the association between medical comorbidity and Healthcare Effectiveness Data and Information Set (HEDIS) treatment initiation and engagement measures.Methods: We used electronic…

Read more

The prevalence of Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement in treatment among patients with cannabis use disorders in 7 US health systems

Background: Cannabis use disorders (CUDs) have increased with more individuals using cannabis, yet few receive treatment. Health systems have adopted the Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of initiation and engagement in alcohol and other drug (AOD)…

Read more

Psychiatric comorbidity and Healthcare Effectiveness Data and Information Set (HEDIS) measures of alcohol and other drug treatment initiation and engagement across 7 health care systems

Background: Psychiatric comorbidity is common among patients with alcohol and other drug (AOD) use disorders. To better understand how psychiatric comorbidity influences AOD treatment access in health care systems, the present study examined treatment initiation and engagement among a large,…

Read more

Predictors of Healthcare Effectiveness Data and Information Set (HEDIS) treatment initiation and engagement among patients with opioid use disorder across 7 health systems

Background: The prevalence of opioid use disorder (OUD) has increased rapidly in the United States and improving treatment access is critical. Among patients with OUD, we examined factors associated with the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures…

Read more

Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States

Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in…

Read more

Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial

Immune responses to 13-valent pneumococcal conjugate vaccine (PCV13) and quadrivalent inactivated influenza vaccine (QIV) in older adults may vary with coadministration and previous pneumococcal polysaccharide vaccination. This study assessed safety and noninferiority of immune responses to coadministered PCV13 and QIV…

Read more

Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants

This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate…

Read more

Association of raltegravir use with long-term health outcomes in HIV-infected patients: an observational post-licensure safety study in a large integrated healthcare system

Raltegravir became the first integrase inhibitor to gain FDA approval; but with limited evidence documenting long-term risks in real world care, especially for major health outcomes of interest. Assess raltegravir safety in clinical practice within an integrated health system. We…

Read more

Factors associated with hazardous alcohol use and motivation to reduce drinking among HIV primary care patients: Baseline findings from the Health & Motivation study

Limited primary care-based research has examined hazardous drinking risk factors and motivation to reduce use in persons with HIV (PWH). We computed prevalence ratios (PR) for factors associated with recent (5) included: moderate/severe depression (PR: 1.43; 1.03, 2.00) and other…

Read more

A Phase IIIB Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants

This is a phase IIIB, observer-blind, randomized, placebo-controlled, multi-center study to assess the safety and immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when administered concomitantly with routine vaccines to healthy infants

Read more

A Continuation of Assessment of the Impact of Prevnar 13 on Invasive Pneumococcal Disease Caused by Vaccine Serotypes of Streptococcus pneumoniae After Introduction Into Routine Pediatric and Adult Use for the Period of May 2015 – April 2020

This project will estimate Prevnar 13 (PCV13) vaccine effectiveness against invasive pneumococcal disease using a test-negative design in the Kaiser Permanente Northern California adult population from September 1, 2014, through December 31, 2017. Positive cases will be defined as patients…

Read more

HIV Infection, Use of Tenofovir and Other Antiretrovirals, and Risk of Fatal and Non-Fatal Comorbidities: Cohort Study in Kaiser Permanente

Although the benefits of combination antiretroviral therapy (ART) for reducing HIV-related morbidity and mortality are well-recognized, toxicity from some ART may potentially contribute to excess age-related comorbidities. Certain antiretrovirals, including tenofovir, have known renal toxicity, but recent formulations may be…

Read more