A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

Phase 3

Completed

Conditions: Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol

Interventions: Biological: Ad26.COV2.S
Other: Placebo

Registration Number: NCT04505722

Lead Sponsor: Janssen Vaccines & Prevention B.V.

Brief Summary: The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44325

Inclusion Criteria

Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires

Exclusion Criteria

Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
Participant previously received a coronavirus vaccine
Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Ad26.COV2.S	Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\10\^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\10\^10 vp dose level.
Ad26.COV2.S	Ad26.COV2.S	Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5\10\^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\10\^10 vp dose level.
Placebo	Placebo	Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5\10\^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5\10\^10 vp dose level.

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase	From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6	Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription/polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute, oxygen saturation (SpO2) \<= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase	From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6	Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute, SpO2 less than or equal to (\<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1])	Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])	Participants who received the booster dose were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase)	Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1])	Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature \>= 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Double Blind Phase)	Month 6	Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 28 Days After Double-blind Vaccination on Day 1 (Day 29): Double-blind Phase	From 28 days after double-blind vaccination on Day 1 (Day 29) up to Month 6	Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute,SpO2 \<=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Area Under the Curve (AUC) of SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Double Blind Phase)	From Day 15 to end of the COVID-19 episode (Day 189)	AUC of SARS-CoV-2 Viral Load was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status With Onset at Least 14 Days After Double-blind Vaccination on Day 1 (Day 15): Double-blind Phase	From 14 days after double-blind vaccination on Day 1 (Day 15) up to Month 6	Molecularly confirmed severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute,SpO2 \<=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Double Blind Phase)	28 days after double-blind vaccination on Day 1 (Day 29)	Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute,SpO2 \<=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
Number of Participants With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)	28 Days after double-blind vaccination on Day 1 (Day 29)	BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Number of Participants With First Occurrence of Molecularly Confirmed, Moderate to Severe/Critical COVID-19 for Seronegative Participants (Double Blind Phase)	1 day after double-blind vaccination on Day 1 (Day 2)	Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate \>= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate \>= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate \>=30 breaths/minute, heart rate \>=125 beats/minute,SpO2 \<=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance. Seronegative is defined as N-serology seronegative at the time of boosting or at the Year 1 visit if not boosted.
Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Double Blind Phase)	28 Days after double-blind vaccination on Day 1 (Day 29)	Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase)	28 Days after double-blind vaccination on Day 1 (Day 29)	Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (\>=38°C or \>=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Double Blind Phase)	14 Days after double-blind vaccination on Day 1 (Day 15)	BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Double Blind Phase)	From Day 29 until end of double-blind phase at Month 6	Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Double Blind Phase)	28 days after double-blind vaccination on Day 1 (Day 29)	Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Double Blind Phase	14 Days after double-blind vaccination on Day1 (Day 15)	Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (\>=38°C or \>=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
Number of Participants With Adverse Events of Special Interest (AESI) (Double Blind Phase)	Baseline (Day 1) up to 35 weeks	Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Double Blind Phase)	28 Days after double-blind vaccination on Day 1 (Day 29)	Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Number of Participants With MAAEs Leading to Study Discontinuation (Double Blind Phase)	Up to 35 weeks	MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Double Blind Phase)	Up to Day 8 (7 Days after double-blind vaccination on Day 1)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Double Blind Phase)	Up to Day 8 (7 Days after double-blind vaccination on Day 1)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with pharmaceutical/biological agent under study. Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature \>= 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Number of Participants With Binding Antibodies to SARS- CoV-2S Protein as Measured by ELISA (Booster Phase)	29 days after booster vaccination on Day 365 (Day 394)	Number of participants with binding antibodies to SARS- CoV-2S protein as measured by ELISA was reported.
Number of Participants With Serious Adverse Events (SAEs) (Double Blind Phase)	Baseline (Day 1) up to 35 weeks	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Number of Participants With Medically-Attended Adverse Events (MAAEs) (Double Blind Phase)	Up to 6 months after double-blind vaccination on Day 1 (up to 6 months)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Double Blind Phase)	Up to Day 29 (28 Days after double-blind vaccination on Day 1)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Double Blind Phase)	Baseline (Day 1), Day 29, and Day 71	Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (\>LLOQ).
Number of Participants With Antibody Titers to Ad26.COV2.S (Booster Phase)	28 days after booster vaccination on Day 365 (up to Day 393)	Number of participants with antibody titers to Ad26.COV2.S to measure immune response were reported.

Trial Locations

Locations (205): Synexus Clinical Research US Inc
🇺🇸
Murray, Utah, United States
University of Alabama Birmingham
🇺🇸
Birmingham, Alabama, United States
Alabama Vaccine Research Clinic at UAB
🇺🇸
Birmingham, Alabama, United States
Optimal Research
🇺🇸
Rockville, Maryland, United States
James A Haley VA Hospital GNS
🇺🇸
Tampa, Florida, United States
Emory University of Medicine
🇺🇸
Atlanta, Georgia, United States
The Hope Clinic at Emory University
🇺🇸
Decatur, Georgia, United States
Johnson County Clin-Trials
🇺🇸
Lenexa, Kansas, United States
Harlem Hospital Center
🇺🇸
New York, New York, United States
Durham VAMC
🇺🇸
Raleigh, North Carolina, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
Gordon Crofoot, MD
🇺🇸
Houston, Texas, United States
Clinical Trials of Texas Inc
🇺🇸
San Antonio, Texas, United States
Hospital Civil Fray Antonio Alcalde
🇲🇽
Guadalajara, Mexico
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
🇲🇽
Merida, Mexico
Centro Medico Nacional Siglo XXI IMSS
🇲🇽
Mexico, Mexico
CAIMED Investigacion en salud S.A de C.V.
🇲🇽
Mexico, Mexico
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
🇿🇦
Soweto, South Africa
The Aurum Institute: Tembisa - Clinic 4
🇿🇦
Tembisa, South Africa
CAPRISA Vulindlela Clinic
🇿🇦
Vulindlela, South Africa
Instituto Brasil de Pesquisa Clinica
🇧🇷
Rio de Janeiro, Brazil
Santa Casa de Misericordia de Belo Horizonte
🇧🇷
Belo Horizonte, Brazil
L2IP Instituto de Pesquisas Clinicas
🇧🇷
Brasilia, Brazil
Centro de Reumatologia y Ortopedia
🇨🇴
Barranquilla, Colombia
Hospital Universidad del Norte
🇨🇴
Barranquilla, Colombia
Centro de Atencion e Investigacion Medica S.A. - CAIMED
🇨🇴
Bogota, Colombia
Medplus Medicina Prepagada S.A.
🇨🇴
Bogota, Colombia
Solano y Terront Servicios Médicos Ltda.
🇨🇴
Bogota, Colombia
Centro de Investigaciones Clinicas S A S
🇨🇴
Cali, Colombia
Fundación Valle del Lili
🇨🇴
Cali, Colombia
SA Medical Research Council
🇿🇦
Durban, South Africa
CRISMO Bertha Gxowa Research Centre
🇿🇦
Johannesburg, South Africa
Shandukani Research Centre
🇿🇦
Johannesburg, South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
🇿🇦
Klerksdorp, South Africa
Qhakaza Mbokodo Research Centre
🇿🇦
KwaZulu-Natal, South Africa
South African Medical Research Council Chatsworth Clinical Research Site
🇿🇦
KwaZulu-Natal, South Africa
VA Medical Center
🇺🇸
Columbia, South Carolina, United States
Central Phoenix Medical Clinic
🇺🇸
Phoenix, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Central Arkansas Veterans Healthcare System
🇺🇸
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
Ark Clinical Research
🇺🇸
Long Beach, California, United States
Anthony Mills Medical, Inc
🇺🇸
Los Angeles, California, United States
Stanford University Medical Center
🇺🇸
Palo Alto, California, United States
UCSD Antiviral Research Center AVRC
🇺🇸
San Diego, California, United States
Wr McCr Llc
🇺🇸
San Diego, California, United States
Childrens Hospital Colorado
🇺🇸
Aurora, Colorado, United States
Rocky Mountain Regional VA Medical Center
🇺🇸
Denver, Colorado, United States
Avail Clinical Research, LLC
🇺🇸
DeLand, Florida, United States
North Florida South Georgia Veteran Health System
🇺🇸
Gainesville, Florida, United States
Velocity Clinical Research, Hallandale Beach
🇺🇸
Hallandale Beach, Florida, United States
Research Centers of America, LLC
🇺🇸
Hollywood, Florida, United States
Suncoast Research Group
🇺🇸
Miami, Florida, United States
University of Miami - Miller School of Medicine
🇺🇸
Miami, Florida, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Advent Health Orlando
🇺🇸
Orlando, Florida, United States
Atlanta VA Medical Center
🇺🇸
Decatur, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Jesse Brown VAMC Department of Surgery
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of IL Chicago
🇺🇸
Chicago, Illinois, United States
The University Of Chicago Medicine
🇺🇸
Chicago, Illinois, United States
Buynak Clinical Research
🇺🇸
Valparaiso, Indiana, United States
Central Kentucky Research Associates, Inc.
🇺🇸
Lexington, Kentucky, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Benchmark Research
🇺🇸
Austin, Texas, United States
Clinical Trials Management, LLC
🇺🇸
Metairie, Louisiana, United States
New Orleans Adolescent Trials Unit CRS
🇺🇸
New Orleans, Louisiana, United States
Southeast Louisiana Veterans Health Care Center
🇺🇸
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Baltimore VA Medical Center
🇺🇸
Baltimore, Maryland, United States
Meridian Clinical Research, LLC
🇺🇸
Endwell, New York, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
The Brigham and Women's Hospital, Inc.
🇺🇸
Boston, Massachusetts, United States
University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center
🇺🇸
Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Cherry Street Services, Inc.
🇺🇸
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital Clinic
🇺🇸
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
MediSync Clinical Research
🇺🇸
Petal, Mississippi, United States
The Center For Pharmaceutical Research
🇺🇸
Kansas City, Missouri, United States
Saint Louis University
🇺🇸
Saint Louis, Missouri, United States
Washington University School Of Medicine
🇺🇸
Saint Louis, Missouri, United States
Clinical Research Center of Nevada
🇺🇸
Las Vegas, Nevada, United States
Clinical Research Consortium, an AMR company
🇺🇸
Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
🇺🇸
Reno, Nevada, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸
New Brunswick, New Jersey, United States
Saint Michaels Medical Center
🇺🇸
Newark, New Jersey, United States
Raymond G. Murphy VA Medical Center
🇺🇸
Albuquerque, New Mexico, United States
Bronx Veterans Affairs Medical Center
🇺🇸
Bronx, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
New York Blood Center
🇺🇸
New York, New York, United States
Rochester Clinical Research, Inc
🇺🇸
Rochester, New York, United States
Tryon Medical Group
🇺🇸
Charlotte, North Carolina, United States
Carolina Institute for Clinical Research
🇺🇸
Fayetteville, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
CTI Clinical Trial and Consulting Services
🇺🇸
Cincinnati, Ohio, United States
Velocity Clinical Research
🇺🇸
Cincinnati, Ohio, United States
Rapid Medical Research
🇺🇸
Cleveland, Ohio, United States
Corvallis Clinic PC
🇺🇸
Corvallis, Oregon, United States
Clinical Research Institute of Southern Oregon, P.C.
🇺🇸
Medford, Oregon, United States
Oregon Health And Science University
🇺🇸
Portland, Oregon, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
PMG Research of Charleston, LLC
🇺🇸
Mount Pleasant, South Carolina, United States
Spartanburg Medical Research
🇺🇸
Spartanburg, South Carolina, United States
St Jude Children's Research Hospital
🇺🇸
Memphis, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Optimal Research, LLC
🇺🇸
Austin, Texas, United States
AIDS Arms Incorporated Trinity Health and Wellness Center
🇺🇸
Dallas, Texas, United States
Baylor Scott and White Research Institute
🇺🇸
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
🇺🇸
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Texas Center for Drug Development Inc
🇺🇸
Houston, Texas, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
Advanced Clinical Research
🇺🇸
West Jordan, Utah, United States
Kaiser Permanente Washington Health Research Institute
🇺🇸
Seattle, Washington, United States
CIPREC
🇦🇷
Buenos Aires, Argentina
Helios Salud Sa
🇦🇷
Buenos Aires, Argentina
CEMEDIC
🇦🇷
Buenos Aires, Argentina
Centro Medico Viamonte SRL
🇦🇷
Ciudad Autonoma Buenos Aires, Argentina
Clinical Trials Division-Stamboulian Servicios de Salud
🇦🇷
Ciudad Autonoma Buenos Aires, Argentina
Clínica y Maternidad Suizo Argentina
🇦🇷
Ciudad Autonoma de Buenos Aires, Argentina
Fundacion Huesped
🇦🇷
Ciudad Autonoma De Buenos Aire, Argentina
CEMIC Saavedra
🇦🇷
Ciudad de Buenos Aires, Argentina
Hospital J. M. Ramos Mejía
🇦🇷
Ciudad de Buenos Aires, Argentina
Instituto Medico Platense
🇦🇷
La Plata, Argentina
Hospital Italiano de La Plata
🇦🇷
La Plata, Argentina
DIM Clinica Privada
🇦🇷
Ramos Mejia, Argentina
Faculdade de Medicina Barretos FACISB
🇧🇷
Barretos, Brazil
Universidade Federal De Minas Gerais - Hospital das Clínicas
🇧🇷
Belo Horizonte, Brazil
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
🇧🇷
Campinas, Brazil
Fundacao Universidade Federal de Mato Grosso do Sul
🇧🇷
Campo Grande, Brazil
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
🇧🇷
Criciúma, Brazil
Oncovida - Centro de Onco-Hematologia de Mato Grosso
🇧🇷
Cuiaba, Brazil
Hospital Nossa Senhora Das Gracas
🇧🇷
Curitiba, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas
🇧🇷
Natal, Brazil
Hospital das Clinicas de Porto Alegre
🇧🇷
Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao S A
🇧🇷
Porto Alegre, Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
🇧🇷
Ribeirao Preto, Brazil
Ministerio da Saude - Hospital dos Servidores do Estado - RJ
🇧🇷
Rio de Janeiro, Brazil
Fundacao Oswaldo Cruz
🇧🇷
Rio de Janeiro, Brazil
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
🇧🇷
Rio de Janeiro, Brazil
Fundacao Bahiana De Infectologia
🇧🇷
Salvador, Brazil
Universidade Municipal de Sao Caetano do Sul
🇧🇷
Sao Caetano do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
🇧🇷
Sao Jose do Rio Preto, Brazil
Instituto de infectologia Emilio Ribas
🇧🇷
Sao Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
🇧🇷
Sao Paulo, Brazil
Centro de Referencia E Treinamento Dst/Aids
🇧🇷
Sao Paulo, Brazil
CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
🇧🇷
Sao Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
🇧🇷
Sao Paulo, Brazil
CPQuali Pesquisa Clinica LTDA ME
🇧🇷
São Paulo, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
🇧🇷
São Paulo, Brazil
Centro de Estudios Clínicos e Investigación Médica (CeCim)
🇨🇱
Santiago, Chile
Facultad de Medicina Universidad de Chile
🇨🇱
Santiago, Chile
Hospital Padre Hurtado
🇨🇱
Santiago, Chile
Centro de Investigacion del Maule
🇨🇱
Talca, Chile
Hospital Dr Hernan Henriquez Aravena
🇨🇱
Temuco, Chile
Centro de Estudios Clinicos V Region Ltda
🇨🇱
Vina del Mar, Chile
Clinica de la Costa
🇨🇴
Barranquilla, Colombia
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
🇨🇴
Floridablanca, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
🇨🇴
Floridablanca, Colombia
Programa de Estudio y Control de Enfermedades Tropicales
🇨🇴
Medellin, Colombia
Fundacion Centro de Investigacion Clinica CIC
🇨🇴
Medellin, Colombia
Hospital Pablo Tobon Uribe
🇨🇴
Medellín, Colombia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽
Ciudad de Mexico, Mexico
Instituto Nacional de Salud Publica
🇲🇽
Cuernavaca, Mexico
Instituto Nacional de Enfermedades Respiratorias
🇲🇽
Mexico, Mexico
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
🇲🇽
Monterrey, Mexico
Infectolab
🇲🇽
Tijuana, Mexico
Centro de Invetigaciones Medicas
🇵🇪
Callao, Peru
Hospital Nacional Daniel Alcides Carrion
🇵🇪
Callao, Peru
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
🇵🇪
Callao, Peru
Asociacion Civil Selva Amazonica (ACSA)
🇵🇪
Iquitos, Peru
Asociacion Civil Impacta Salud y Educacion - Barranco
🇵🇪
Lima - Barranco, Peru
Hospital Nacional Edgardo Rebagliati Martins
🇵🇪
Lima, Peru
Hospital Nacional Arzobispo Loayza
🇵🇪
Lima, Peru
Asociacion Civil Via Libre
🇵🇪
Lima, Peru
Instituto de Investigacion Nutricional
🇵🇪
Lima, Peru
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
🇵🇪
Lima, Peru
Josha Research
🇿🇦
Bloemfontein, South Africa
Synexus Helderberg Clinical Research Centre
🇿🇦
Cape Town, South Africa
Family Clinical Research Unit FAM-CRU
🇿🇦
Cape Town, South Africa
TASK Central
🇿🇦
Cape Town, South Africa
Desmond Tutu HIV Foundation
🇿🇦
Cape Town, South Africa
University of Cape Town IDM/CIDRI Research Site
🇿🇦
Cape Town, South Africa
Desmond Tutu Hiv Foundation - University Of Cape Town
🇿🇦
Cape Town, South Africa
Masiphumelele Research Centre
🇿🇦
Cape Town, South Africa
Ndlovu Elandsdoorn Site
🇿🇦
Dennilton, South Africa
Centre for the AIDS Programme of Research in South Africa
🇿🇦
KwaZulu-Natal, South Africa
Stanza Clinical Research Centre : Mamelodi
🇿🇦
Mamelodi East, South Africa
Mzansi Ethical Research Centre
🇿🇦
Middelburg, South Africa
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
🇿🇦
Mthatha, South Africa
PHOENIX PHARMA (Pty) Ltd
🇿🇦
Port Elizabeth, South Africa
MeCRU Clinical Research Unit
🇿🇦
Pretoria, South Africa
Synexus Watermeyer
🇿🇦
Pretoria, South Africa
The Aurum Institute Rustenburg Clinical Research Site
🇿🇦
Rustenburg, South Africa
Setshaba Research Centre
🇿🇦
Soshanguve, South Africa
Perinatal HIV Research Unit (PHRU), Kliptown
🇿🇦
Soweto, South Africa
University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre
🇿🇦
Westdene Johannesburg Gauteng, South Africa
SATVI, Brewelskloof Hospital
🇿🇦
Worcester, South Africa