Ongoing Clinical Trials for Rubella
This article provides information about ongoing clinical trials focused on rubella. Currently, there are 3 clinical trials studying vaccines that protect against rubella, along with other related viral infections such as measles, mumps, and chickenpox. These trials are being conducted in several European countries and involve different patient groups, from young cancer survivors to healthy children and adults. (Also known as: German measles)
Clinical trial locations
- Denmark
- Latvia
- Spain
- Sweden
Study on Immunity to Measles and Chickenpox in Children with Cancer Using Measles, Mumps, Rubella, and Varicella Vaccines
This trial is focused on children and adolescents aged 0 to 18 years who have been treated for cancer. The study aims to understand how well these young patients can rebuild their immunity against measles and chickenpox after completing cancer treatment.
Who can join: Participants must be children or adolescents starting cancer treatment whose vaccination status for measles and chickenpox before cancer treatment is known. Female participants who have started menstruating and are sexually active must agree to use effective birth control methods, including combined pills, intravaginal rings, contraceptive patches, progesterone-only methods, intrauterine devices, sterilization, or abstinence. They must also have a negative pregnancy test at the time of all vaccinations. Parents or guardians must provide signed consent after receiving oral and written information about the trial.
Who cannot join: The trial excludes patients who have not completed their cancer treatment or reached a stable health condition afterward. Those with known allergies to the varicella or measles vaccines, patients with weakened immune systems, and those currently taking immune-suppressing medications like steroids are not eligible. Patients who have recently received blood transfusions or blood products, or who have other serious health conditions that doctors believe would make participation unsafe, are also excluded.
What the trial studies: The trial examines how the immune system responds to revaccination with combination vaccines for measles, mumps, and rubella, as well as a separate vaccine for varicella. Researchers will measure the levels of specific antibodies in the blood before and after vaccination to determine if the vaccines are effective in providing protection. The study will compare immune responses among participants based on factors such as the type of cancer, treatment intensity, and whether participants had immunity to these diseases before their cancer treatment. The study is expected to continue until 2028.
Vaccines being tested: The trial uses the varicella vaccine to protect against chickenpox and the measles vaccine to protect against measles. Both vaccines are administered through intramuscular injection and contain live, attenuated forms of the viruses, which are weakened versions that cannot cause disease but can trigger an immune response.
Study on Immune Response and Safety of Measles, Mumps, Rubella, and Varicella Vaccine in Healthy Children Aged 4 to 6 Years
This trial studies the immune response and safety of a new vaccine designed to protect against measles, mumps, rubella, and varicella in healthy children aged 4 to 6 years. The new vaccine is being compared to an existing vaccine called ProQuad.
Who can join: Participants must be healthy children between 4 and 6 years old, as determined by their medical history and clinical examination. They must have received their first dose of a varicella vaccine and a single dose of an MMR vaccine during their second year of life. Written informed consent must be obtained from parents or legally acceptable representatives before any study procedures are performed, and the child will also be asked for their agreement to participate according to local rules. Parents or guardians must be able and willing to follow study requirements, including completing electronic diaries and attending follow-up visits.
Who cannot join: The trial excludes participants with serious health conditions or weakened immune systems, whether due to diseases or medications that affect the body’s ability to fight infections. Pregnant or breastfeeding individuals, those with a history of allergic reactions to vaccines, and participants who have received other vaccines within a certain period before the study are not eligible. Those taking medications that might affect the immune system, individuals with uncontrolled chronic illnesses, those with a history of substance abuse, and participants who have recently participated in another clinical trial are also excluded.
What the trial studies: The study evaluates how well the new vaccine generates an immune response compared to the ProQuad vaccine. Researchers will measure the levels of antibodies in the children’s blood to determine how effectively the vaccines protect against the viruses. The study will also track common side effects such as fever or rash, as well as any serious adverse events. Children will receive either the new vaccine or ProQuad as a single injection under the skin and will be followed for several months to observe their immune response and safety outcomes.
Vaccines being tested: The trial tests two vaccines: MMRVNS vaccine, a new vaccine designed to protect against measles, mumps, rubella, and varicella, and MMRV vaccine, a combination vaccine already in use. Both vaccines help the body build up its immune system to fight off these viruses if exposed in the future. They are classified as live attenuated vaccines, containing weakened forms of the viruses.
Study on the Effectiveness of Skin Patch Vaccination with Measles, Mumps, and Rubella Vaccine in Healthy Volunteers
This trial explores a new method of administering the MMR vaccine by comparing traditional injection under the skin with a new approach called epicutaneous vaccination, where the vaccine is applied to the skin surface. The study involves healthy adult volunteers.
Who can join: Participants must be between 18 and 34 years old and must not have received the MMR vaccine before. They must be in good health, and female participants must use safe methods to prevent pregnancy during the study.
Who cannot join: The trial excludes individuals who have had severe allergic reactions to any component of the MMR vaccine, people with weakened immune systems, and pregnant women. Anyone who has received another vaccine within the last 4 weeks, participants with a fever or other signs of illness at the time of the study, and those currently taking immune-affecting medications such as steroids are not eligible. People with a history of blood disorders or bleeding problems, anyone who has received a blood transfusion or blood products in the last 3 months, and participants who have joined another clinical trial within the last 30 days are also excluded.
What the trial studies: The study compares two different methods of administering the MMR vaccine to see if the new skin patch method can generate a similar immune response to the traditional injection method. Researchers will focus on the production of IgA antibodies, which play a crucial role in the body’s defense against respiratory infections. Participants will receive both types of vaccine administration at different times, and their immune responses will be measured over three months through tests on nasal secretions, blood samples, and possibly tonsil brushings. The study will also monitor any side effects that may occur after vaccination.
Vaccine being tested: The trial uses the M-M-RvaxPro vaccine, a combination vaccine that protects against measles, mumps, and rubella. In this study, the vaccine is applied using epicutaneous vaccination to see if this method can effectively trigger immune responses in the respiratory system. The MMR vaccine is classified as a live attenuated vaccine, containing weakened forms of the viruses that do not cause disease in healthy people.
Summary
The three ongoing clinical trials for rubella focus on different aspects of vaccination and involve diverse patient populations. One notable observation is the concentration of trials in Northern and Central European countries, including Sweden, Latvia, Spain, and Denmark. Two trials focus on pediatric populations: one studying revaccination in children who have undergone cancer treatment, and another testing a new vaccine formulation in healthy children aged 4 to 6 years. The third trial explores an innovative vaccination method in healthy adults.
All three trials involve vaccines that protect against multiple diseases, with rubella being one component alongside measles, mumps, and in some cases, varicella. The trials examine both the effectiveness of these vaccines in generating immune responses and their safety profiles. The study in Sweden is particularly focused on vulnerable populations who may have weakened immune systems due to cancer treatment, while the Danish trial explores new delivery methods that could potentially make vaccination more accessible in the future.