Ongoing Clinical Trials for Monkeypox (Mpox)
There are currently 5 clinical trials ongoing across Europe studying treatments and vaccines for monkeypox. These trials are taking place in multiple countries including the Netherlands, Ireland, France, Sweden, Spain, Portugal, Belgium, Italy, Norway, and Germany. The research focuses on both vaccine effectiveness and antiviral treatment options, particularly testing the MVA-BN vaccine and the antiviral medication tecovirimat. (Also known as: Mpox, Monkeypox virus disease)
Clinical trial locations
- Belgium
- France
- Study on Monkeypox Virus Disease: Effects of Tecovirimat in Patients with and without Antiviral Treatment
- Study on the Safety and Immune Response of the MVA-BN Vaccine Booster for Monkeypox Prevention in Previously Vaccinated Patients
- Study on Tecovirimat for Treating Monkeypox in Patients with Confirmed Infection
- Germany
- Ireland
- Study on the Effectiveness of Modified Vaccinia Ankara Vaccine in Preventing Mpox Infection in Adults
- Study on Monkeypox Virus Disease: Effects of Tecovirimat in Patients with and without Antiviral Treatment
- Study on the Safety and Immune Response of the MVA-BN Vaccine Booster for Monkeypox Prevention in Previously Vaccinated Patients
- Italy
- Netherlands
- Norway
- Portugal
- Spain
- Sweden
Study of Different Doses of MVA-BN Vaccine Booster for Adults with Mpox: Comparing Standard and Reduced Doses
This trial is testing whether a smaller dose of the MVA-BN vaccine can provide the same level of protection as the standard dose when given as a booster shot. The vaccine, known as IMVANEX, contains a modified form of the vaccinia virus designed to help the body build immunity against mpox.
Main inclusion criteria: Participants must be adults aged 18 years or older who were born after 1974 and have already received two doses of the MVA-BN vaccine at least one year before joining. They should be generally healthy, though people with stable pre-existing conditions can participate if their condition hasn’t required significant treatment changes in the previous six weeks. Those who can become pregnant must agree to use effective birth control for at least four weeks after vaccination and must not be pregnant or breastfeeding at the time of joining.
Main exclusion criteria: People cannot participate if they are under 18 or over 64 years old, have been previously diagnosed with mpox infection, are currently pregnant or breastfeeding, have known allergies to vaccine components, have a weakened immune system, have severe bleeding disorders, or have participated in other clinical trials within the past 30 days.
Focus and goal: The trial aims to determine if a reduced dose of the vaccine can produce a similar immune response to the standard dose. Participants receive one booster injection under the skin and are monitored for six months. Blood samples are collected at specific intervals to measure antibody levels and assess how well the vaccine is working.
Investigational drug: The study uses MVA-BN vaccine, a live modified form of the vaccinia virus that has been adapted to be safer while still providing immunity. It is administered as a subcutaneous injection to boost immune protection in previously vaccinated individuals.
Study on the Effectiveness of Modified Vaccinia Ankara Vaccine in Preventing Mpox Infection in Adults
This Irish trial is studying how the body’s immune response changes over time after receiving the IMVANEX vaccine. The research focuses on understanding how long the vaccine’s protection lasts and what factors might influence this.
Main inclusion criteria: Participants must be at least 18 years old, understand the study procedures, and provide voluntary written consent. They must be eligible for one or two doses of the MVA vaccine according to health authority guidelines, or have received their first dose less than 28 days ago.
Main exclusion criteria: Individuals who currently have an active mpox infection cannot participate in the study.
Focus and goal: The trial monitors antibody levels at various time points over 48 weeks following vaccination. It also tracks the presence of mpox virus DNA through throat, anorectal, or vaginal swabs at regular intervals. The study examines the vaccine’s ability to neutralize the virus in laboratory settings and monitors for any other infections that might occur during the study period.
Investigational drug: The MVA vaccine is administered to help the body develop protective antibodies against the mpox virus. The study aims to provide information on how effective this vaccine is in preventing mpox infection.
Study on the Safety and Immune Response of the MVA-BN Vaccine Booster for Monkeypox Prevention in Previously Vaccinated Patients
This multi-country trial across Sweden, Ireland, and France is comparing two different methods of giving the MVA-BN vaccine booster: one injected just under the skin and another injected into the skin itself. The goal is to determine if both methods produce similar immune responses.
Main inclusion criteria: Adults aged 18 years or older who received a dose of the MVA-BN vaccine at least four months ago and are willing to participate throughout the entire study period. At specific trial sites, eligibility is focused on men who have sex with men, and women must test negative in a pregnancy test.
Main exclusion criteria: People cannot join if they are not within the specified age range, belong to vulnerable populations, have medical conditions that could interfere with the study, have had severe allergic reactions to vaccine components, are currently in another clinical trial, are pregnant or breastfeeding, have a weakened immune system, received a live vaccine within 30 days, have certain skin conditions like eczema, or have serious uncontrolled chronic illnesses.
Focus and goal: The trial monitors participants’ immune responses at various intervals including one, three, six, and up to 24 months after the booster dose. Blood samples are taken to measure antibody levels, which are proteins that help fight infections. The study aims to identify the best way to administer the MVA-BN vaccine for optimal protection.
Investigational drug: The MVA-BN vaccine is being tested as a booster shot to enhance the body’s immune response. The trial compares intradermal administration (into the skin) with subcutaneous administration (under the skin) to determine which method produces better results.
Study on Monkeypox Virus Disease: Effects of Tecovirimat in Patients with and without Antiviral Treatment
This large observational study is taking place across eight European countries: Portugal, Belgium, Spain, Italy, France, Norway, Ireland, and the Netherlands. It examines the clinical outcomes in patients with mpox who are treated with tecovirimat or other antiviral drugs, as well as those who receive no antiviral treatment.
Main inclusion criteria: Patients must have either a laboratory-confirmed case of mpox or be managed as a presumptive case while awaiting lab results. They must provide informed consent to participate. Both males and females of all ages, including children, adults, and the elderly, can participate. Patients from vulnerable populations are also eligible.
Main exclusion criteria: Patients without a diagnosis of mpox, those outside the specified age range, those unwilling to follow study procedures, those currently in another clinical trial, those with medical conditions making participation unsafe, pregnant or breastfeeding women, those with known allergies to the study medication, and those who have already received certain treatments for mpox before the study starts cannot participate.
Focus and goal: The study monitors how quickly skin lesions heal, starting from the date of a positive test or beginning of treatment, for up to 14 days. It assesses overall health status on days 14 and 28, and checks for disease recurrence on days 60 and 180. The study also tracks mpox virus DNA levels in throat, blood, and lesion swabs, monitors for serious side effects within 28 days, and considers outcomes for pregnant participants.
Investigational drug: Tecovirimat is taken in the form of 200 mg hard capsules. It works by stopping the virus from spreading in the body, helping to reduce disease severity and speed up recovery.
Study on Tecovirimat for Treating Monkeypox in Patients with Confirmed Infection
This randomized trial is being conducted across eight European countries: Spain, Netherlands, Germany, France, Portugal, Norway, Italy, and Belgium. It evaluates the effectiveness of tecovirimat by comparing patients who receive the active treatment against those who receive a placebo.
Main inclusion criteria: Participants must have a PCR or NAAT test-confirmed mpox infection and have active skin or mucosal lesions. They must provide signed informed consent. Both males and females within the specified age range, including adults and children, can participate.
Main exclusion criteria: Patients without a confirmed diagnosis of mpox, those not within the specified age range, and those belonging to vulnerable populations with certain health conditions that make them more at risk cannot participate.
Focus and goal: The trial’s primary aim is to observe the time it takes for all skin and mucosal lesions to heal completely. Participants are assessed at days 7, 14, 21, and 28 to check lesion status and symptoms such as fatigue, nausea, or pain. The study also evaluates quality of life changes, monitors for negative mpox tests, assesses any scars or skin discoloration, and tracks complications, hospital admissions, or deaths that may occur.
Investigational drug: Tecovirimat SIGA 200 mg hard capsules are taken orally. The medication is designed to help clear up skin and mucosal lesions and speed up the healing process for patients with mpox.
Summary
The current landscape of mpox clinical trials in Europe reveals a balanced focus between prevention and treatment approaches. Three trials concentrate on vaccine optimization, specifically examining the MVA-BN vaccine in various dosing strategies and administration methods. These vaccine studies are distributed across the Netherlands, Ireland, France, and Sweden, with a particular emphasis on booster dose effectiveness and different injection techniques.
On the treatment side, two major trials are evaluating tecovirimat, an antiviral medication, across multiple countries including Spain, Portugal, Belgium, Netherlands, Germany, France, Norway, and Italy. The widespread geographic distribution of the treatment trials, spanning eight countries, indicates a coordinated European effort to gather comprehensive data on antiviral effectiveness.
The Netherlands, France, and Ireland emerge as key research hubs, each hosting multiple trials. The vaccine trials primarily target previously vaccinated individuals seeking booster protection, while the treatment trials welcome a broader population including those with confirmed infections. This dual approach reflects the medical community’s commitment to both preventing new infections and improving outcomes for those already affected by mpox.
