(Image from Mosaico Study website)
In the ongoing fight to combat the HIV pandemic around the world, a new study — partially happening in Orlando — could potentially hold the answer to a vaccine.
Mosaico is a study testing two experimental vaccines against HIV: referred to as the Ad26 vaccine and the protein vaccine. The vaccines are designed to create an immune response against not only common strands of the HIV virus found in the western world but also common strands from Africa and Asia as well, potentially laying a path for a vaccination that could be used worldwide.
The study is sponsored by Johnson & Johnson’s Janssen Pharmaceutical Companies, who is also supplying the study vaccines, and was developed along the HIV Vaccine Trials Network and the National Institute of Allergy and Infectious Disease. The study will involve cisgender men and transgender people— between the ages 18 and 60 — who have not been infected with HIV but are at high risk due to their sexual relations with other cisgender men or transgender people.
The study is taking place at multiple clinics in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain and the United States. Currently, 19 clinics across the U.S. are a part of the study, including two in Florida — the University of Miami’s ID CRU at Jackson Memorial Hospital and the Orlando Immunology Center.
Dr. Charlotte Rolle, director of research operations at the OIC and the lead researcher for the Mosaico study in Orlando, broke down the process of the Mosaico trial.
“This is a four-dose vaccine strategy, the last two doses of the vaccine are actually given with an adjuvant. In this trial, it is aluminum phosphate,” Rolle says. “This is a very popular adjuvant used in vaccine studies, it boosts immune responses. The body recognizes aluminum is extremely foreign and so when a vaccine is attached to that it forces the body to make a powerful immune response.”
Only half of the participants will receive the preventative vaccine, while half will receive a placebo. The study is designed to find out if the study vaccines actually work in preventing or fighting HIV.
Finding active and willing participants had been difficult throughout the study. Rolle’s research team was actively seeking participants of color, in order to gather more research on how these vaccines actively affect those communities.
“It’s been very challenging selling the vaccine study to individuals in the community, especially when you think about the target population which is actually not only people who are at high risk of acquiring HIV but the Mosaico study has very specific racial and ethnic benchmark targets they were trying to meet,” Rolle says. “They did actually encourage us to only enroll patients from diverse backgrounds, which was a bit hard. We were asked to enroll MSM — men who have sex with men — and transgender individuals of color, specifically, individuals from Latinx or African American communities. That was sort of really tough because those communities are sort of traditionally not as engaged in the health care system in general, so finding them and talking to them about a vaccine study has been difficult.”
Rolle and the OIC team worked with a community advisory board, which was made up of the target community to gather their opinions and more information.
Though research had been done with the similar Imbokodo study with female participants in southern Africa, which was not found to offer protection against HIV, it was decided that although the two had similar vaccine regimens, the addition of a second component in the protein vaccine and participants’ genetic biology differed enough to continue with the Mosaico vaccine trials.
Researchers for the Mosaico study have heavily emphasized the fact that the vaccines are made from synthetic (laboratory-made) copies of HIV pieces and cannot cause HIV infection in participants. The study vaccine regimen is currently planned only to be used for research.
The study began enrolling participants in November 2019 and had been enrolling individuals throughout 2020 and 2021. The full study has enrolled 3,800 participants, along with being between the ages of 18-60, participants tested negative on an HIV test, had to be in good health and could not be actively taking PrEP, or pre-exposure prophylaxis.
According to the Kaiser Family Foundation, nearly 38 million people are currently living with HIV around the world. If the Mosaico trials are successful it could potentially open the door for more comprehensive studies in the future. The study is expected to take around four years to complete.
For more information on the Mosaico vaccine study, visit MosaicoStudy.com.
