As a result of the COVID-19 pandemic, and to help ensure the safety of participants and study staff, the leadership of the Mosaico Study has temporarily paused all new screening, enrollments, and vaccination visits. The pause will be reassessed in the coming weeks to determine next steps. Study participants that have been screened or enrolled should reach out to their study site for information and updates. For general inquiries about the Mosaico Study, please contact email@example.com. Please follow the guidance of your local health authorities and government agencies on how to protect yourself and others from COVID-19 infection. ______________________________________________________________________
A vaccine teaches the body to prevent a particular infection or fight a disease. In order to develop a vaccine, researchers need to test it in people. A vaccine study tests whether the vaccine is safe (does not cause health problems) and whether people’s immune systems respond to the study vaccines. Your immune system protects you from disease. A vaccine study can also be used to find out if a vaccine might help prevent or fight an infection or disease. It takes many vaccine studies to produce a safe, effective vaccine.
Currently there is no licensed vaccine against HIV or AIDS.
HVTN 706/HPX3002 tests 2 experimental vaccines against HIV. The study vaccines are called Ad26.Mos4.HIV and Bivalent gp140. Bivalent gp140 is made of 2 proteins called Clade C gp140 and Mosaic gp140. These vaccines are developed by Janssen Vaccines & Prevention B.V. From here on, we will call them the Ad26 vaccine and the Protein vaccine and refer to them together as the study vaccines. The study vaccines are not made from live HIV, killed HIV, or HIV-infected human cells. These study vaccines cannot cause HIV infection or AIDS.
The Ad26 vaccine
The Ad26 vaccine is made from a virus called Adenovirus type 26. This vaccine has parts of HIV inserted. It is designed to tell the body to make proteins that are similar to proteins found in HIV. (Proteins are natural substances that are found in all living things, such as the human body and viruses such as HIV.) The body’s immune system may respond to the copies of HIV proteins in the study vaccine. This is called an immune response. An immune response prepares the body to recognize the same proteins in HIV and fight the virus if a person is exposed to HIV in the future. Adenovirus type 26 is a common virus in everyday life and can cause colds and respiratory infections. However, the adenovirus used in this study vaccine has been weakened so it cannot cause colds.
The Protein vaccine
The protein vaccine is made from man-made proteins that are similar to a protein found on the surface of HIV. The Clade C gp140 protein is made to resemble an HIV protein most commonly found in southern Africa. The Mosaic gp140 is made to resemble a mix of many different HIV proteins found around the world. The body’s immune system may respond to these proteins and recognize the same proteins in HIV and fight the virus if a person is exposed to HIV in the future.
Bivalent gp140 is mixed with an adjuvant called Aluminum Phosphate. An adjuvant is a substance added to a vaccine to increase the immune response. Aluminum is used in many common vaccines such as those for Hepatitis A and B, diphtheria, and tetanus.
We can give you more detailed information about the study vaccines, if you would like.
Janssen Vaccines & Prevention B.V., the National Institute of Allergy and Infectious Diseases (NIAID), and the HIV Vaccine Trials Network (HVTN) developed this study. Janssen Vaccines & Prevention B.V. is the regulatory sponsor and is also supplying the study vaccines. NIAID is part of the National Institutes of Health (NIH), which is part of the United States government
The HVTN is an international collaboration of scientists, educators, and community members searching for an effective and safe HIV vaccine. The HVTN is funded by NIAID.
The study enrolled the first participant in November 2019, and will continue enrolling participants throughout 2020. It will be conducted in these locations:
Argentina: Buenos Aires, Rosario
Brazil: Belo Horizonte, Curitiba, Manaus, Rio de Janeiro, São Paulo
Mexico: Guadalajara, Merida, Mexico City
Peru: Iquitos, Lima
Italy: Milan, Modena, Rome
Poland: Gdansk, Warsaw, Wroclaw
Spain: Barcelona, Cordoba, Madrid, Valencia
United States of America: Atlanta, Birmingham, Boston, Chicago, Cleveland, Houston, Miami, Memphis, Nashville, New Orleans, New York, Newark, Orlando, Philadelphia, Rochester, San Francisco, Seattle, Washington, DC, West Palm Beach.
The mission is to find a safe and effective HIV vaccine. The main purposes of the study are:
The study involves a target of 3800 participants.
To join this study, a volunteer must be a cis-gender man or a transgender person who has sex with cis-gender men and/or transgender persons. They must be between 18 and 60 years of age, not infected with HIV, and chosen to not use pre-exposure prophylaxis (PrEP) to prevent HIV infection. There are also other criteria that must be met. We will ask people about their medical history; give them a physical exam; and take blood, oral/rectal swabs, and urine samples for testing. We will also ask people about their sexual activity and drug use.
We do not know all the risks of the study vaccines. This Ad26 vaccine in this study (“Ad26.Mos4.HIV”) is being tested in 3 other studies that started before Mosaico. In total, almost 3,000 healthy adult participants have been enrolled into these 3 clinical studies. From these studies, we have unblinded information on 236 participants (from the US, Rwanda, and Kenya) and can report that the vaccine has not made people too uncomfortable. A similar Ad26 vaccine (“Ad26.Mos.HIV”) has been tested in other studies and given to approximately 400 individuals. In those studies, the vaccine similarly did not cause health problems in those people or make people too uncomfortable. The most commonly reported side effects with these Ad26-vectored HIV vaccines are injection site pain (pain where the injection was given), headache, feeling tired, and muscle aches.
The Protein vaccine is made from two parts, Clade C gp140 and Mosaic gp140. The Clade C gp140 part (without the Mosaic gp140 part) has been given in 6 other studies which enrolled over 3000 study participants. To date, the results show that the product does not cause serious health problems, and the most frequently reported side effects are headache, upset stomach, feeling tired, and injection site pain. The Clade C gp140 protein has been given in combination with the Mosaic gp140 protein to only approximately 100 participants in one ongoing study. So far, no significant health problems have been reported in those people, however there is the potential for more serious safety problems to arise.
The Protein vaccine is given with an aluminum phosphate adjuvant. An adjuvant is a substance added to a vaccine to increase the immune response. Aluminum adjuvants have been used safely in vaccines for more than 70 years.
Participants should not expect to be protected from HIV by these study vaccines. In fact, participants may not even get the study vaccines in this study, since some participants (approximately half) will get a placebo. A placebo is an injection that contains no study vaccine, such as sterile salt water.
This study is designed to find out if the study vaccines work to prevent or fight HIV. However, more studies may need to be done to learn if they do.
Because we don’t know if the study vaccines will prevent HIV/AIDS, participants in this study will be counseled on how to avoid behavior that will put them at risk of HIV infection.
The study is expected to take around 4 years.
Protecting the health and respecting the rights of participants are top priorities for everyone in the HVTN and at Janssen. Without volunteers, we would never be able to find an HIV vaccine.
A first step in protecting the rights of study participants is to give them information about the study before they join. Clinic staff will give people information about the study products and procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they wish to continue in the study, and the right to leave the study at any time.
During the study, the clinic staff will monitor participants to make sure the study vaccines are not causing health problems. The clinic staff will also ask participants about any social problems they may experience from being in the study. If a participant has a health or social problem related to being in the study, clinic staff will work with them to find ways to resolve them.
There are several groups involved in protecting participants’ rights and well-being:
Yes, the study vaccines are likely to cause you to test positive on some types of HIV tests. If a participant gets an HIV study vaccine, their body may make antibodies to HIV. Antibodies help you fight infection. Standard HIV tests search for HIV antibodies as a sign of infection. Because of this, a person could have a positive HIV test result even if they are not infected with HIV. This is called a vaccine-induced seropositive (VISP) test result. You may also see this called Vaccine-Induced Seroreactive. We do not know who will have VISP test results or how long these test results may last.
People with VISP test results need specific HIV tests to determine if a positive test result is due to VISP or a true infection. Clinics participating in this study have access to these specific tests that look for the virus itself instead of looking for antibodies.
No health problems are associated with a VISP test result, but VISP test results may cause problems in several areas such as medical or dental care, employment, insurance, a visa for traveling, or entry into the military. You might not be allowed to donate blood or other organs. If you are planning to apply for insurance, employment, or the military inform your study site right away. The insurance company, employer, or military agency may not accept HIV test results from the HVTN. However, the HVTN can work with them to ensure the right test is done that will show your true HIV status.
About HIV vaccine clinical studies: www.clinicaltrials.gov
About the HIV Vaccine Trials Network: www.hvtn.org
If you have additional questions that were not answered by this document, please ask us.
You can contact: firstname.lastname@example.org