KIGALI, Rwanda — Nearly 40 years after HIV was discovered, scientists are cautiously optimistic they are on the brink of a vaccine effective enough to roll out on a wide scale. Results from advanced vaccine trials are expected in the coming years.
But even if an effective vaccine is found — is the world ready to roll it out?
That’s the question some researchers and advocates are asking, warning that the global health community needs to lay the groundwork in expectation of good results, in order to avoid delays of a vaccine rollout and consequently increased infections that could have been prevented with a vaccine.
“This is the epidemic of our time, and we will be defined by how we handle this.”— Dr. Larry Corey, principal investigator, HVTN
A successful, timely rollout of the vaccine will require discussions and collaboration among the global health community and potential manufacturers of the vaccine, as well as increased resources — starting now, researchers said this month at the International Conference on AIDS and Sexually Transmitted Infections in Africa in Rwanda.
“People are working hard, involved in the science and daily grind, hoping for a safe vaccine that works. But it’s important to start thinking about: What if it works? Are we prepared to actually take it forward?” said Dr. Simba Takuva, regional medical liaison for Sub-Saharan Africa for the HIV Vaccine Trials Network.
If a successful vaccine is found, it will be the most complicated vaccine the world has ever seen, according to HIV vaccine researchers, as the virus has high levels of mutations and different strains are found globally.
While prospects of finding a cure for HIV are more elusive, some researchers also argue that now is the time to also start planning for a rollout.
“This is the epidemic of our time, and we will be defined by how we handle this,” said Dr. Larry Corey, principal investigator at HVTN.
Awaiting vaccine trial results
The HIV crisis, which began in the early 1980s, has claimed the lives of about 32 million people globally.
While there is now a tool kit of prevention and treatment options for HIV, the world will not eradicate the virus without a vaccine, Corey said.
More on HIV/AIDS
But the complexity of the HIV virus has stumped scientists working on a vaccine for decades. There is no natural immune response to model a vaccine, animal studies of the vaccine have failed, the virus does not have a typical response to vaccines, it has a high mutation rate, and different subtypes of HIV occur globally.
In 2009, for the first time, researchers in Thailand published results from a trial where a vaccine showed protection against HIV. But the protection wasn’t high enough, and the duration of the protection wasn’t long enough, to bring it to market. In response, researchers embarked on new vaccine trials, working to build off these gains.
Now, there are three advanced vaccine trials. Results from two of the vaccine trials are expected in 2022.
If a vaccine is found at least 50% efficacious — the percent reduction in the contraction of the disease in vaccinated individuals compared to people not vaccinated — it could trigger efforts to license a vaccine and then roll it out.
If any of these vaccines show above 50% efficacy in the coming years, it could be on the market in less than a decade, Corey said.
“It is really exciting times and we need to be prepared for the outcome — whether it's success or failure,” said Roger Tatoud, deputy director of vaccines in HIV programs and advocacy at the International AIDS Society.
Amid a rollout, scientists continue to work to improve levels and length of protection against HIV for future versions of a vaccine, as well as conduct “bridging” studies, such as testing out the safety of the vaccine when given to adolescents.
But rolling out vaccinations has historically been marred by delays in areas such as the regulatory process, community sensitization, and obtaining funds.
Rolling out the malaria vaccine, for example, experienced delays. After partial efficacy of the vaccine was found in 2014, GlaxoSmithKline and its partners have "been navigating complex regulatory and implementation planning processes,” according to a recent article in The Lancet, which says widespread rollout of the vaccine is years away and needs more funding.
“It is really exciting times and we need to be prepared for the outcome — whether it's success or failure.”— Roger Tatoud, deputy director of vaccines in HIV programs and advocacy, International AIDS Society
Manufacturing at scale
Laying the groundwork for the large-scale manufacturing of the vaccine is key, HIV vaccine researchers told Devex.
“Making a product consistently with millions of doses and a high quality is not an easy job,” Corey said.
Before the efficacy of a vaccine is known, the global health community can start conversations about how many people to vaccinate and engage with potential manufacturers on what pricing could look like at different levels of efficacy, researchers said.
With the help of health economists and disease modelers, the global health community can create a business case to convince potential manufacturers that investing in the vaccine makes sense financially, said Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Centre at the University of Cape Town.
This would also include conversations around funding with organizations such as the Global Alliance for Vaccines and Immunization and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
After a flurry of last-minute commitments, the Global Fund narrowly surpassed its $14 billion target. Devex journalists dive into how the replenishment conference in Lyon unfolded — and what it means for the future of global health financing.
"If you look at the malaria vaccine... it wasn't until the European Medicines Agency approved it that the company came to us as funders, when I was at the Global Fund, and said we need $20 million to start implementing a study — We don't just have $20 million lying around. You need to plan for this, you need to actually have this stuff thought out and planned," said Mark Dybul, former executive director of the Global Fund, during a press conference this month in Kigali.
The Global HIV Vaccine Enterprise, currently housed at the International AIDS Society, is a good platform to help facilitate these conversations and bring stakeholders together, according to HIV vaccine researchers.
Challenges with distribution and stigma
Beyond planning for manufacturing, there are concerns about how the public health sector would distribute a vaccine.
One of the vaccines under trial includes six doses, repeated every few years. No other vaccines in the world require that many doses, according to HIV vaccine researchers. This concerns some in the global health community about whether communities would adhere to the full course of doses.
“Even if we had a 50% efficacy, could we move forward with a vaccine that requires six doses?” Bekker asked.
Researchers might need to increase the potency, in order to decrease the number of doses, Corey said.
The global health community can start discussing now which high-risk groups to target initially, because blanket targeting would be too costly, HIV vaccine researchers said.
“The shortage of existing health-care programmes that target many of the populations that are likely to be prioritised to receive an HIV vaccine, pose a substantial challenge,” according to an article in The Lancet.
Starting conversations on dealing with stigma are also crucial, according to researchers.
“If you target high risk populations, it could stigmatize a vaccine that needs widespread distribution,” Bekker said.
Targeting adolescents could also be a challenge as it involves conversations about sex, she said.
The global health community should take into account lessons from the roll out of the HPV vaccine, which targets adolescents, according to researchers. In some countries, the HPV vaccine was framed as a vaccine targeting a sexually transmitted infection and in other countries, it was framed as a vaccine to prevent cervical cancer.
“Countries that deployed it as a cancer vaccine didn't meet some of the resistance in comparison to other countries where they deployed as an STI vaccine,” Bekker said.
Preparing for a cure
Prospects of a cure are less tangible than those for a vaccine, but some researchers and advocates are also calling for conversations to start on the roll out of a cure.
This includes engagement, particularly at the community-level, Dybul said, to examine how people would respond to a cure and start implementing that feedback into its design.
An initial conversation was held in February in California, where about 30 members of the HIV scientific, pharmaceutical, funding, and NGO communities met to discuss the rollout of a potential cure in the future. Out of the meeting, a public-private partnership called the HIV Cure Acceleration for Africa was created that includes representatives in the fields of research and development, regulatory agencies, health care implementers, civil society, and potential funders that aim to hasten both the development of a cure and ensure the widest possible access.
A working group was also developed to create a “target product profile” to define what characteristics of a product would make it widely acceptable for communities to implement. The working group will examine areas such as which populations to target, the costs of a future cure, and the ways in which it could be delivered to communities. The working group includes representatives from the pharmaceutical industry, research institutions, advocacy groups, and potential funders.
"The purpose is two-fold so that we can move as quickly as possible as products become available because everyone's been engaged from the beginning. But also so that there can be feedback, and people can modify their approach based on the conversations," Dybul said.
One reason behind these conversations is to avoid community resistance during the roll out of a cure, Dybul said. In the early days of antiretroviral therapy for HIV, there was resistance to the pills for reasons including concerns that the pills were killing people rather than treating them, he said. This is because communities weren’t involved in the early conversations.
“We keep thinking that human beings are lab animals,” Dybul said. “If we don't start engaging now, then when we do have something we are going to be behind and a lot of lives are going to be lost.”
Editor’s note: The International AIDS Society facilitated Devex's travel and logistics for this reporting. Devex maintains full editorial independence and control of the content.