Since the COVID-19 pandemic began, data for decision-making have been needed by public health practitioners worldwide. In the U.S., the Centers for Disease Control and Prevention (CDC) plays a critical role in combatting the pandemic and conducting research. CDC’s real-time surveillance of COVID-19 cases and analyses of surveillance data inform public health policies, communication about protective behaviors, and guidance to public health and healthcare providers, communities, businesses, and schools.
This need continues today, but early in the pandemic CDC urgently required research data to inform the COVID-19 response, especially related to risk and protective factors across key population groups. They included healthcare personnel, first responders, and essential workers; pregnant women and infants; individuals 50 years and older; older adults in continuting care retirement communities; and households.
Methods
From the first few months of the COVID-19 pandemic, Abt supported a variety of CDC COVID-19 research initiatives. Since 2013 under a contract with CDC, Abt managed an infrastructure of clinical health organizations set up to conduct network studies to assess risk and characterize disease epidemiology of novel influenza or other novel respiratory viruses among different population cohorts. Abt recognized that it could pivot and use this infrastructure to perform these tasks for COVID-19. Abt has significant experience with the approaches needed to provide the studies and data CDC required. They include:
- Study design
- Recruitment
- Data collection and coordination
- Data management, cleaning, and analytic file preparation
- Specimen collection, processing, and testing
- Technical assistance and training
- Project management
In addition, under a separate contract, Abt provided staff to the CDC’s COVID-19 Epidemiology Task Force. The CDC Epidemiology Task Force was responsible for identifying and tracking COVID-19 cases, spread, and containment and was critical to accomplishing CDC’s mission and goals during the COVID-19 pandemic.
Research
Studying cohorts with different characteristics and vulnerabilities is critical to understanding how an infectious disease spreads and affects the human population. It’s especially important for monitoring vaccine safety and effectiveness. Our infectious diseases and clinical research experts have led COVID-19 cohort studies with CDC and partners to assess:
- household transmission
- transmissibility of infection
- rates of infection and illness
- clinical epidemiology of the disease
- characteristics of medically and non-medically attended cases.
Dive into the Abt team’s six cohort studies below.
Research on the Epidemiology of SARS-CoV-2 in Essential Response personnel (RECOVER) Study
The RECOVER study was a prospective, longitudinal cohort study of approximately 3,000 healthcare personnel, first responders, and essential workers from six U.S. geographies. This research offered CDC timely information on COVID-19 illness characterization and correlates of protection in this highly-exposed cohort. The research also provided rates of asymptomatic infection and re-infection and estimates of vaccine effectiveness for the COVID-19 vaccines against different variants. Data collection started in July 2020 and continued through June 2023.
Read More About the Research:
- Data Collection on COVID-19 Vaccine Effectiveness for CDC Required Quick Pivot (Press Release)
- Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers - Eight U.S. Locations, December 2020-March 2021 (Journal Article - CDC Morbidity and Mortality Weekly Report)
- Prevention and Attenuation of COVID-19 with the BNT162b2 and mRNA-1273 Vaccines (Journal Article – New England Journal of Medicine)
- Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance – Eight U.S. Locations, December 2020 – August 2021 (Journal Article – CDC Morbidity and Mortality Weekly Report)
- Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER): Protocol for a Multisite Longitudinal Cohort Study (Journal Article – JMIR Publications)
- COVID-19 Vaccine Perceptions and Uptake in a National Prospective Cohort of Essential Workers (Journal Article – Vaccine)
- Neutralizing Antibody Response to Pseudotype Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Differs Between mRNA-1273 and BNT162b2 Coronavirus Disease 2019 (COVID-19) Vaccines and by History of SARS-CoV-2 Infection (Journal Article – Oxford Academic)
- Incidence of SARS-CoV-2 infection among COVID-19 vaccinated and unvaccinated healthcare personnel, first responders, and other essential and frontline workers: Eight US Locations, January-September 2021 (Journal Article – Wiley Online Library)
- Protection of a Third Dose of mRNA Vaccine against SARS-CoV-2 Variants in Frontline Workers (Journal Article – New England Journal of Medicine)
- Detection and Stability of SARS-CoV-2 in Three Self-Collected Specimen Types: Flocked Midturbinate Swab (MTS) in Viral Transport Media, Foam MTS, and Saliva (Journal Article – ASM Journals)
- COVID-19 Vaccination Perspectives and Illnesses Among Law Enforcement Officers, Firefighters, and Other First Responders in the US, January to September 2021 (Journal Article – JAMA Network Open)
- Association of mRNA Vaccination with Clinical and Virologic Features of COVID-19 Among US Essential and Frontline Workers (Journal Article – Journal of the American Medical Association)
- Severe Acute Respiratory Syndrome Coronavirus 2 Infection History and Antibody Response to 3 Coronavirus Disease 2019 Messenger RNA Vaccine Doses (Journal Article – Oxford Academic)
- Risk Factors for Reinfection with SARS-CoV-2 Omicron Variant among Previously Infected Frontline Workers (Journal Article – Emerging Infectious Diseases)
Epidemiology of SARS-CoV-2 in Pregnancy and Infancy (ESPI) Network Study
Pregnant women may be more vulnerable to respiratory infections and severe respiratory complications, and more research is needed on potential effects of these on birth outcomes. ESPI leveraged an existing network of sites and protocols from the CDC Pandemic Flu and Global Flu contracts to conduct two separate cohort studies among pregnant women. Findings from this study provided timely information for CDC on the risk factors for infection and characteristics of COVID-19 illness and complications, as well as the effects of infection on pregnancy and infant outcomes. A better understanding of this burden may help inform future public health policy regarding pregnant women, young infants, and COVID-19.
Read More About the Research:
- Association between SARS-CoV-2 infections during pregnancy and preterm live birth (Journal Article - Influenza and Other Resp Viruses)
- Neutralizing Antibody Responses to mRNA COVID-19 Vaccines versus SARS-CoV-2 Infection Among Pregnant Women and Vaccine Induced Antibody Transfer to Infants (Journal Article - Open Forum Infectious Diseases)
- Assessment of Neurodevelopment in Infants With and Without Exposure to Asymptomatic or Mild Maternal SARS-CoV-2 Infection During Pregnancy (Journal Article - JAMA Network)
- Incidence Rates of Medically Attended COVID-19 in Infants Less Than 6 Months of Age (Journal Article - Pediatric Infectious Disease Journal)
- Agreement Between Pregnant Individuals' Self-Report of Coronavirus Disease 2019 (COVID-19) Vaccination and Medical Record Documentation (Journal Article — Obstetrics & Gynecology)
- Medically-attended Influenza During Pregnancy in the 2019-20 and 2020-21 Influenza Seasons (Journal Article — Obstetrics & Gynecology)
- SARS-CoV-2 Testing and Detection During Peripartum Hospitalizations Among a Multi-center Cohort of Pregnant Persons, March 2020–February 2021 (Journal Article — Clinical Infectious Diseases)
- Incidence and Clinical Characteristics of and Risk Factors for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Pregnant Individuals in the United States (Journal Article — Clinical Infectious Diseases)
- Factors Associated with Hospitalization with Symptomatic COVID-19 Illness Among Pregnant Individuals: A Multi-Center Retrospective Cohort Study (Journal Article — Open Forum Infectious Diseases)
- Attitudes Toward COVID-19 Illness and COVID-19 Vaccination among Pregnant Women: A Cross-Sectional Multicenter Study during August-December 2020 (Journal Article — American Journal of Perinatology)
Geisinger Electronic Cohort Study and Geisinger Prospective Case-Control Study
Older adults are at high risk for contracting novel coronavirus and for developing severe COVID-19 illness if infected. This study consisted of two activities:
- an electronic cohort that used electronic medical record extraction to monitor and describe medical care for hospitalized patients aged ≥50 years old in a rural health care system.
- prospective enrollment and follow-up of a subset of test-positive study participants and matched test-negative controls who were admitted to inpatient care and tested for novel coronavirus.
The study examined serologic indicators of infection, correlates of protection, and patterns of medical care and health outcomes among three age groups (50-64 years, 65-79 years, 80+ years old).
COVID-19 Illness and Testing among Retirement Communities in the US (CITRUS) Cohort Study
Older adults are among those with the highest risk for medically attended COVID-19. Characterization of risk factors and clinical epidemiology of COVID-19 among older adults may inform public health strategies to prevent infection and reduce the burden of severe disease in this population. Within participating retirement communities, the CITRUS project enrolled nearly 300 residents from different resident groups (independent living homes and assisted living facilities). Active surveillance captured COVID-19 cases among both symptomatic and asymptomatic participants. The primary objectives of the CITRUS cohort were to: 1) estimate the cumulative incidence of asymptomatic and symptomatic infection in community-dwelling older adults in the US; and 2) establish kinetics of immunity over time. Secondary objectives included describing illness severity, risk factors for infection, healthcare utilization, and immune response to vaccination and vaccine effectiveness when the SARS-CoV-2 vaccines became available.
Coronavirus Household Evaluation and Respiratory Testing (C-HEaRT) Cohort Study
Household studies offer researchers a unique opportunity to capture illnesses among individuals who do not seek medical care. These studies allow for a better understanding of the true burden of disease and other characteristics of the illness. C-HEaRT adapted existing methodologies used during influenza pandemics to assess epidemiological and clinical characteristics of COVID-19. They included incidence, risk of transmission and infection, illness progression, clinical characteristics of severity, modifying behaviors, serum biomarkers, and other characteristics. Findings from this study supported CDC’s role during a pandemic for monitoring pandemic-related illness, describing the epidemiology of pandemic virus infection and the burden of disease, and monitoring and evaluating the use of public health interventions, antiviral treatment, and vaccine effectiveness.
In addition to C-HEaRT, Abt led data management-related activities for its sister study, SARS-CoV-2 Epidemiology And Response in Children (SEARCh), which was led by researchers at Johns Hopkins University.
Read More About the Research:
- Study Finds COVID-19 Vaccines Reduce Chance of Infection and Isolation Measures Reduce Household Transmission (Press Release)
- Impact of Age and Symptom Development on SARS-CoV-2 Transmission in Households With Children—Maryland, New York, and Utah, August 2020–October 2021 (Journal Article — Open Forum Infectious Diseases)
- Study Shows COVID-19 Saliva Samples Yield Test Results as Accurate as Nasal Swabs (Press Release)
- Detection and Stability of SARS-CoV-2 in Three Self-Collected Specimen Types: Flocked Midturbinate Swab (MTS) in Viral Transport Media, Foam MTS, and Saliva (Journal Article - Microbiology Spectrum)
- Abt/CDC Study Finds Children and Adults Have Similar Coronavirus Infection Rates (Press Release)
- Incidence Rates, Household Infection Risk, and Clinical Characteristics of SARS-CoV-2 Infection Among Children and Adults in Utah and New York City, New York (Journal Article - JAMA Pediatrics)
Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) Study
The PROTECT study was a longitudinal pediatric cohort study that evaluated COVID-19 vaccines’ real-world effectiveness in 2,300 U.S. children in four geographies. The study provided recruitment and retention support, and ongoing estimates of COVID-19 vaccines’ real-world effectiveness (including boosters and additional doses) in children aged 6 months to 17 years as vaccine products were authorized for certain pediatric populations. In addition, the study monitored the incidence of SARS-CoV-2 and influenza infection in this pediatric population. Data collection began in July 2021 and continued through May 2023.
Read More About the Research:
- Effectiveness of Bivalent mRNA COVID-19 Vaccines in Preventing SARS-CoV-2 Infection in Children and Adolescents Aged 5 to 17 Years (Journal Article - JAMA)
- Humoral Immune Response to Messenger RNA Coronavirus Disease 2019 Vaccination Among Children Aged 5-11 Years in a Multisite Prospective Cohort Study, September 2021 - September 2022 (Journal Article - Open Forum Infectious Diseases)
- Parental Intentions and Perceptions toward COVID-19 Vaccination Among Children Aged 4 Months to 4 Years — PROTECT Cohort, Four States, July 2021–May 2022 (Journal Article — CDC Morbidity and Mortality Weekly Report)
- Study Shows Declining Parental Interest in COVID-19 Vaccine for Young Children (Press Release)
- Effectiveness of 2-Dose BNT162b2 (Pfizer BioNtech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5-11 Years and Adolescents Aged 12-15 Years – PROTECT Cohort, July 2021 – February 2022 (Journal Article – CDC Morbidity and Mortality Weekly Report)
- Interim Estimate of Vaccine Effectiveness of BNT162b2 (Pfizer-BioNTech) Vaccine in Preventing SARS-CoV-2 Infection Among Adolescents Aged 12-17 Years—Arizona, July-December 2021 (Journal Article – CDC Morbidity and Mortality Weekly Report)
- Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study (Journal Article – JMIR Publications)