Infections

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Infectious Mononucleosis

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). 91 routinely collected samples were analyzed by Immulite, Architect, and Liaison Blood samples were centrifuged for 15 min at 2500g at room temperature. Sera were aliquoted and first analyzed by Immulite. All samples were tested for EBV VCA IgG, EBV VCA IgM and EBV EBNA IgG in order to determine infection status (primary EBV infection, past infection, absence of infection and indeterminate status).

Serological giagnosis

Sandrine Castelain, MD, PhD

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

This retrospective study was conducted on 91 samples collected between 2014 and 2015 for which EBV diagnosis was requested. The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). The median age of patients was 34 years (mean: 38 years, range: 3-82 year) with a sex ratio of 50%. Sixteen of the 91 samples concerned children (\<15 years).

This study compared the performance of three automated immunoassays, Architect (Abbott), Immulite (Siemens) and Liaison (Diasorin), for Epstein-Barr virus (EBV) serology. Ninety-one serum samples collected in Amiens University Hospital were analyzed for the presence of Viral Capsid Antigen (VCA) IgG and IgM and Epstein-Barr Nuclear Antigen (EBNA) IgG. The agreement between the three assays was calculated for each marker individually and for determination of the EBV profile, based on interpretation of the combination of these three EBV markers.

Comparison of Technics for Determination of Epstein-Barr Virus Serological Diagnosis

Comparison of Abbott Architect®, Siemens Immulite®, and Diasorin Liaison® for Determination of Epstein-Barr Virus Serological Diagnosis

The aim of the present study is to evlaute the capacity of the three tests to detect VCA IgM. 91 samples was collected and tested for EBV VCA IgG, EBV VCA IgM and EBV EBNA IgG in order to determine infection status (primary EBV infection, past infection, absence of infection and indeterminate status).

Centre Hospitalier Universitaire, Amiens

Disease Attributes

Leukocyte Disorders

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Anti-Infective Agents

All Drugs and Chemicals

Antiviral Agents

Valomaciclovir 2 grams orally twice daily for 21 days

placebo 2 tablets twice daily for 21 days

4 grams orally of valomaciclovir (2 grams BID) for 21 days.

Valomaciclovir

Placebo tablets orally twice daily for 21 days.

placebo

Henry H Balfour, MD

This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.

Subjects will be seen 2 times a week for 3 weeks and then weekly for 3 weeks. Clinical findings, clinical lab tests, EBV viral loads, and EBV antibody titers will be obtained at each clinic visit.

Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection

Randomized, Placebo-Controlled, Double-Blind Study to Assess Clinical and Antiviral Activity of Valomaciclovir (EPB 348) in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono 6)

All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline

Assessing adverse events in participants to see if this drug causes more or less side effects

Epiphany Biosciences

University of Minnesota

Valomaciclovir 2 grams orally twice daily for 21 days

Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.

placebo 2 tablets twice daily for 21 days

placebo : Placebo tablets orally twice daily for 21 days.

Placebo

Total

<=18 years

Between 18 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Hank Balfour MD

Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline

Valomaciclovir 2 grams orally twice daily for 21 days

Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days.

placebo 2 tablets twice daily for 21 days

placebo: Placebo tablets orally twice daily for 21 days.

Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability

Overall Study

Vaccines

Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.

Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.

mRNA-1189

0.9% sodium chloride (normal saline) injection

The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults and the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old EBV-seronegative healthy adolescents.

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with \> 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.

ModernaTX, Inc.

Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.

mRNA-1195.1

mRNA-1195.2

The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy adults (18 to 55 years of age).

There will be 2 sequential parts to the study:

* Participants will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening.
* Part B will enroll only those participants who are EBV-seronegative at Screening.

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Adults 18 to 55 Years of Age

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Syndrome

Uterine Cervical Dysplasia

Body Weight

Dermatitis

Psoriasis

Thrombocytopenia

Herpes Simplex

Weight Loss

Diarrhea

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Pneumonia

Sexually Transmitted Diseases

Lymphadenopathy

Candidiasis

Herpes Zoster

Leukopenia

Sexually Transmitted Diseases, Viral

Dermatitis, Seborrheic

Skin Diseases

Skin Diseases, Papulosquamous

Blood-Borne Infections

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Body Weight Changes

Signs and Symptoms, Digestive

Blood Platelet Disorders

Cytopenia

Slow Virus Diseases

Chickenpox

Varicella Zoster Virus Infection

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Mycoses

Bacterial Infections

Bacterial Infections and Mycoses

Sebaceous Gland Diseases

Skin Diseases, Eczematous

Cervical Intraepithelial Neoplasia

Chronic Graft Versus Host Disease

Medical specialists in hospitals and their patients aged 18 years and older in the participating hospitals who are diagnosed there with an HIV indicator condition.

General practitioners and their patients aged 18 years and older in the participating general practices who are diagnosed there with an HIV indicator condition.

HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing

Peer to peer feedback

Free HIV rapid tests are provided to non-HIV specialised treating physicians to use in individual patient care in patients at risk of HIV

HIV rapid test

Casper Rokx, MD PhD

Carlijn C Jordans, PhD

Maartje M Wagemaker, RN

Casper C Rokx, PhD MD

Bart B Rijnders, PhD MD

Adam A Anas, PhD MD

Jeroen J van Kampen, PhD MD

Robert Jan Sips, PhD

Jet Gisolf, MD PhD

Annelies Verbon, Prof

Femke Mollema, MD PhD

Rachida El Moussaoudi, MD PhD

Zoltan Szlavik, PhD

David vd Vijver, PharmD PhD

Renee Finkenflugel, Msc

Anna Roukens, MD PhD

Patients are frequently evaluated by physicians for medical work-up of HIV indicator conditions in hospital and in primary care at the general practitioner. Testing for HIV is indicated with HIV indicator disorder but often omitted in clinical work-up. Besides the fact that HIV testing is forgotten, there are other reasons such as an underestimation of the risk of HIV in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. Also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle.

This project focuses on improving HIV indicator condition driven testing in different settings of the HIV epidemic, initially in the Netherlands as low HIV prevalence setting followed by an assessment of its benefit in different international settings. A specific focus will also be on the Rotterdam area in the Netherlands which has a high prevalence of undiagnosed HIV in the Netherlands. The ultimate aim is to decrease the number of undiagnosed HIV in populations, improve the 90-90-90 HIV cascade of care goals particularly its first pillar, and to help supporting the UNAIDS goal to end HIV/AIDS

HIV Indicator Diseases in Hospital and Primary Care

Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.

Costs of the program in relation to the savings in costs and QALY's lost as a consequence of earlier HIV diagnosis with subsequent prevented HIV transmission, AIDS comorbidity and hospital admissions.

Huisartspraktijk Gezondheidscentrum Mathenesserlaan

TU Delft department of Artificial Intelligence and MyTomorrows

Huisartsen Groep Rotterdam

AwareHIV Project Group

Huisartspraktijk Handellaan

Huisartspraktijk Leerdam

Huisartspraktijk Capelle ad IJssel

Leiden University Medical Center

Maasstadziekenhuis

Rijnstate Hospital

Medical Center Haaglanden

Erasmus Medical Center

MD PhD

Antibodies

Immunoglobulins

Antibodies, Blocking

Adult participants with or without prior EBV infection will receive 3 doses of vaccine

A 50 micrograms dose of EBV gp350-Ferritin vaccine will be administered intramuscularly for each vaccination at Days 0, 30, and 180 to all participants.

EBV gp350-Ferritin Vaccine

Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1.

Matrix-M1

Jessica R Durkee-Shock, M.D.

Background:

Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine.

Objective:

To test the safety of and immune response to a new vaccine against EBV.

Eligibility:

Healthy adults ages 18-29

Design:

Participants will be screened with a medical history and physical exam. They will give a blood sample.

Screening tests will be repeated during the study.

Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined.

Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study.

Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose.

Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person.

Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.

Study Description:

Phase 1 study to evaluate the safety and immunogenicity of a 3-dose vaccination regimen of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Based on data reported in animal studies, our hypothesis is that this EBV vaccine will be safe and will induce a potent EBVgp350-specific immune response. Twenty EBV seropositive participants and 20 EBV seronegative participants will receive 3 doses of vaccine at 0, 1, and 6 months. Subjects will be followed until 12 months after the third dose of vaccine with an option to be followed for an additional year.

Objectives:

Primary objective:

To determine the safety and immunogenicity of an adjuvanted EBV gp350- Ferritin vaccine administered as 3 intramuscular injections to healthy adults with or without prior EBV infection.

Secondary objective: To further evaluate the immunogenicity of an adjuvanted EBV gp350-Ferritin vaccine administered to healthy adults.

Endpoints:

Primary endpoint consists of:

* Local and systemic reactogenicity signs and symptoms during the 7-day period after each vaccination
* Unsolicited adverse events up to 30 days after each vaccination
* Serious adverse events through Day 210
* Change in log10 antibody response to EBV from baseline to 1 month after the third dose of vaccine (Day 210) as measured by neutralization assay

Secondary endpoints:

* Change in log10 antibody response to EBV gp350 from baseline to Day 210 as measured by luciferase immunoprecipitation system (LIPS) assay
* Change in log10 CD4 T cell response to EBV gp350 from baseline to Day 210 as measured by intracellular cytokine staining

Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

Phase 1 Study of the Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350- Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Technics for Determination of Epstein-Barr Virus Serological Diagnosis	NCT03650231	EBV	Serological gia...	3 Years - 82 Years	Centre Hospitalier Universitaire, Amiens
Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection	NCT00575185	Infectious Mono...	Valomaciclovir placebo	15 Years -	University of Minnesota
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults	NCT05164094	Epstein-Barr Vi...	mRNA-1189 Placebo	12 Years - 30 Years	ModernaTX, Inc.
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults	NCT05831111	Epstein-Barr Vi...	mRNA-1195.1 mRNA-1195.2 mRNA-1189 Placebo	18 Years - 55 Years	ModernaTX, Inc.
HIV Indicator Diseases in Hospital and Primary Care	NCT05225493	HIV Infections Primary Health ... Acquired Immuno... Sexually Transm... Herpes Zoster Dermatitis, Seb... Pneumonia Infectious Mono... Psoriasis Candida Infecti... Lymphadenopathy Uterine Cervica... Weight Loss Diarrhea Chroni... Leukopenia Thrombocytopeni... AIDS Defining I... HIV Indicator C...	Peer to peer fe... HIV rapid test	18 Years -	Erasmus Medical Center
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults	NCT05831111	Epstein-Barr Vi...	mRNA-1195.1 mRNA-1195.2 mRNA-1189 Placebo	18 Years - 55 Years	ModernaTX, Inc.
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection	NCT04645147	EBV Epstein-Barr Vi... Infectious Mono...	EBV gp350-Ferri... Matrix-M1	18 Years - 29 Years	National Institutes of Health Clinical Center (CC)
Study on Infectious Mononucleosis in Munich	NCT06002802	Infectious Mono... Epstein-Barr Vi...		0 Years - 39 Years	Technical University of Munich
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults	NCT05164094	Epstein-Barr Vi...	mRNA-1189 Placebo	12 Years - 30 Years	ModernaTX, Inc.

Spots Global Cancer Trial Database for infectious mononucleosis