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An Experimental H.I.V. Vaccine Fails in Africa

An Experimental H.I.V. Vaccine Fails in Africa

An advanced H.I.V. vaccine trial in Africa has been shut down after data showed the shots offered only limited protection against the virus, researchers announced on Tuesday.

The vaccine, made by Johnson & Johnson, is one in a long line found to offer little defense against H.I.V., one of medicine’s most intractable adversaries. One candidate vaccine even increased the risk of infection.

Another trial was halted last year in South Africa after a different experimental vaccine failed to offer sufficient protection. Some 1.5 million people were infected with H.I.V. worldwide in 2020, and 38 million are living with the infection.

Scientists were dismayed by the most recent failure.

“I should be used to it by now, but you’re never used to it — you still put your heart and soul into it,” said Glenda Gray, the principal investigator of the trial and chair of the South African Medical Research Council. Dr. Gray has been working to develop an H.I.V. vaccine for more than 15 years.

Entirely new approaches may be needed. This month, Moderna announced that it would test a vaccine based on the mRNA platform used to devise the company’s coronavirus vaccine.

The trial, called Imbokodo, tested an experimental vaccine in 2,600 young women deemed at high risk of H.I.V. infection in five sub-Saharan African countries. Women and girls accounted for almost two-thirds of new H.I.V. infections in the region last year.

The trial was funded by Johnson & Johnson, the Bill and Melinda Gates Foundation, and the National Institutes of Health.

The vaccine relied on an adenovirus called Ad26, modified to carry fragments of four H.I.V. subtypes into the body in hopes of provoking an immune response that might defend against infection.

Mitchell Warren, executive director of AVAC, an advocacy group that lobbies for AIDS prevention and treatment, said the cancellation of the trial was a “reality check” amid excitement about new vaccine technologies.

“It’s a grand reminder that H.I.V. is a pathogen unlike any other in its complexity,” he said. “We know the platform worked, but what do we put in it? Because this virus is infecting the exact same immune system that we’re trying to boost with a vaccine.”

Participants in the Imbokodo trial, which began in 2017, were given two initial shots and two boosters over the course of a year. Researchers tracked the numbers of new infections in the placebo and vaccine groups from the seventh month (one month after the third vaccination) through the 24th month.

Over two years, 63 of 1,109 participants who received the placebo were infected with H.I.V., compared with 51 of 1,079 participants who received the vaccine — giving the vaccine an efficacy rate of 25 percent.

Earlier studies, including one carried out in Thailand, had indicated that the kind of antibodies this vaccine provoked might be sufficient to offer good protection from H.I.V. for at least an initial period of time.

“But in South Africa, the higher rates of H.I.V. incidence means you need something much more potent,” Dr. Gray said. “The kind of immune responses that were induced were just not enough to stop the high attack rates we see in Africa.”

When the disappointing data showed a low efficacy rate, guidelines set up before the trial dictated it should be shut down. A vaccine that offered only 25 percent protection risked giving women a “false sense of security,” Dr. Gray said.

But a parallel trial that uses a different iteration of this vaccine will continue, Johnson & Johnson said. It is being tested on men who have sex with men and transgender people, in eight countries including Poland, Brazil and the United States.

That study, called Mosaico, is testing the vaccine against different subtypes of H.I.V. in different populations, and could produce different efficacy results.

Dr. Gray said that the lesson from the failed trial lies in figuring out why it worked for the 25 percent of people who were protected and not for the others, and then trying to translate those clues into a recipe for a future vaccine.

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World News

PEPFAR Is Nonetheless With out a Chief. H.I.V. Activists Wish to Know Why.

PEPFAR Is Still Without a Leader. H.I.V. Activists Want to Know Why.

The Biden administration has not yet nominated a leader for the President’s Emergency Plan for AIDS Relief, a $7 billion program that sets priorities for AIDS care worldwide — leaving countries that receive funding from the program without guidance during a pandemic that is particularly dire for those with H.I.V.

PEPFAR is led by a global AIDS coordinator, a cabinet-level position that was last held by Dr. Deborah Birx. Dr. Birx served from April 2014 to February 2020, when she left to join the White House coronavirus task force. Dr. Angeli Achrekar, a deputy, has acted as PEPFAR’s interim leader since President Biden took office.

Global health experts sharply criticized the delay in nominating a permanent chief. “Can we not think and act on two pandemics at a time?” asked Gregg Gonsalves, a longtime H.I.V. activist and an epidemiologist at the Yale School of Public Health.

PEPFAR was started in 2003 by President George W. Bush and has had bipartisan support ever since. Funds distributed by PEPFAR are used to support prevention and treatment programs, including offering voluntary male circumcision, as well as testing for H.I.V. and providing antiretroviral therapy to people of all ages.

It is widely regarded as the most successful global health program. Since its inception, the U.S. government has invested more than $85 billion in more than 60 countries, saving an estimated 20 million lives.

“PEPFAR is an example of what can be done when you combine diplomacy and global health,” said Dr. Carlos del Rio, an infectious-disease expert at Emory University in Atlanta and chair of PEPFAR’s scientific advisory board. “Throughout Africa, they love and they respect the U.S. because of PEPFAR.”

Credit…U.S. Department of State

Last week, a group of more than 50 advocacy organizations sent a letter to Mr. Biden, urging him to “immediately appoint a bold, creative and qualified” leader for PEPFAR. “This is unacceptable, particularly during a time of the dueling pandemics of H.I.V. and Covid-19,” they wrote.

The White House did not respond to a request for comment.

The coronavirus pandemic has disrupted access to H.I.V. prevention, diagnosis and treatment, as well as supply chains for condoms, lubricants and antiretroviral drugs, according to a recent report from UNAIDS.

And the pandemic has reversed hard-gained progress on ending H.I.V., including a 23 percent annual decrease in new infections since 2010.

The inertia on naming a leader is particularly damaging “when more leadership, ambition and governance is sorely needed to guide global efforts to make up lost ground on the H.I.V. response,” said Suraj Madoori, a director of the Treatment Action Group, an advocacy organization based in New York.

A new study released last week showed that people living with H.I.V. have a heightened risk of serious illness and death from Covid-19. The coronavirus pandemic could also benefit from the health care infrastructure set up to provide services for H.I.V., experts noted.

“There’s a lot that can happen now, using the PEPFAR structure to confront Covid in those countries,” Dr. del Rio said.

“Not leveraging the PEPFAR infrastructure — I think it’s crazy, it’s a huge missed opportunity,” he added. “This administration has been around for six months. Why have we not appointed them?”

Dr. del Rio said PEPFAR’s chief had been noticeably absent from global conversations, including a recent U.N. resolution to end AIDS by 2030, and efforts to enable PEPFAR sites to respond to the coronavirus pandemic. It’s also important for PEPFAR’s chief to speak up for the program when budget dollars are allocated, Dr. del Rio added: “I almost feel like the program is basically at a standstill.”

The absence of a U.S. voice is also having ripple effects on many issues in African countries, said Richard Lusimbo, a program manager at Pan Africa ILGA in Uganda. Core programs for key populations like L.G.B.T.Q. people have been cut in several countries since the start of the Biden administration. In Ivory Coast, for example, the budget for key population services was cut by half.

In Kenya, a dispute between its government and the U.S. Agency for International Development has led to a shortage of antiretroviral drugs. A permanent PEPFAR leader with political power would have been able to resolve that dispute, Mr. Lusimbo said.

Mr. Biden named Samantha Power to lead USAID on Jan. 13, even before he took office. And last week, the White House announced nominees for seven other positions.

For weeks, the H.I.V. community has heard that the administration is considering five widely known global health experts to lead PEPFAR: Shannon Hader, Charles Holmes, Chris Beyrer, Vanessa Kerry and Paul Farmer. But no candidate has emerged as the front-runner.

“Unfortunately, we are watching as global support for the Covid-19 response in Africa is missing, the AIDS response is being weakened, and it is not clear who the U.S. government’s leader is on this,” Mr. Lusimbo said. “Does the administration not understand that, for our communities, the AIDS response and the Covid-19 response are critically interlinked?”

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Health

Covid Is Particularly Dangerous for Individuals With H.I.V., Giant Research Finds

Covid Is Especially Risky for People With H.I.V., Large Study Finds

“HIV knocks out all the brakes on the immune system, and as a consequence you get this inflammatory response that is robust and persistent – and now you still have Covid,” said Dr. Steven Deeks, an HIV expert at the University of California, San Francisco. “I would be surprised if HIV wasn’t linked to the progression of Covid-19”.

Updated

July 15, 2021, 7:14 p.m. ET

Dr. Deeks disagreed with the study researchers’ decision to adjust the calculations for the presence of other conditions such as obesity, as HIV infection itself can cause many of these diseases. “For 25 years we have argued that a history of HIV infection is an independent risk factor for the progression of heart disease, cancer and aging,” he said. Without this statistical adjustment, the increased risk of death for these patients would most likely have been higher than the 30 percent reported in the study.

Many previous studies had a bias that could have masked some of the risk: Doctors tend to hospitalize Covid-19 patients with HIV out of caution, which means patients are less sick and more likely to survive compared to those who do not having HIV.This larger number of patients would make HIV infection seem less of a problem than it is, said Dr. Matthew Spinelli, an infectious disease doctor at San Francisco General Hospital.

“Early studies may have misled people on this issue,” he said. The results of the new study are more in line with large, population-based studies from South Africa and England showing HIV infection doubles the risk of dying from Covid-19, and from a similar study in New York state, he added added.

The new findings should prompt doctors to give people with HIV quick access to monoclonal antibodies or antiviral drugs to treat Covid-19, said Dr. Deeks. The data also underscores the need to understand how HIV infection affects a person’s response to a Covid vaccine and whether some people with HIV need a booster vaccination, as many immunocompromised people do.

AIDS activists successfully campaigned for the inclusion of people with HIV in clinical trials with coronavirus vaccines, but the data are limited. A clinical study in South Africa showed the coronavirus vaccine, manufactured by Novavax, to be more effective than analysis excluded people with HIV, suggesting that HIV infection undermines the immune response to vaccines.

Out of 100 countries that have released information, 40 listed people with HIV as a priority group for Covid-19 vaccination, said Dr. Meg Doherty, WHO directs HIV programs

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Health

The Metropolis Shedding Its Kids to H.I.V.

The City Losing Its Children to H.I.V.

At a government hospital in Larkana, I watched a nurse leave a needle open after preparing medication in the children’s ward. Then she tossed it in a regular trash can with the tip still exposed. I did not see any containers for sharp objects. Outside, I asked a cleaner how the hospital handles rubbish. He led me past the hospital gates and showed me the trash that was lined up around its perimeter. There were exposed needles, infusion cannulas, and dirty nebulizer masks everywhere. An incinerator was nearby but was not used. (WHO has since donated new incinerators, but the pandemic has delayed their installation.)

As an ambulance, I have provided medical care overseas in all sorts of dire environments. Still, I was shocked here. Even in impoverished, war-drained countries in sub-Saharan Africa, I was held to the strictest infection control standards as a medical student. The nurses in the operating, work, and delivery rooms had eyes in the back of their heads to warn anyone who violated the protocol. In an HIV ward in South Africa, I was shocked by the tearing words of a fellow student, a local woman, when I was clumsy with a needle. She warned me that no matter how rushed I was, this task cannot be compromised. It is the first lesson we learn here as students, she explained.

Syringes with built-in safety locks that slide forward easily to cover the needle are common in American healthcare facilities, but even the Aga Khan does not have them. In the best case scenario, the plunger will be locked so that the syringe cannot be reused. When I went to several pharmacies that dispose of these needles and asked about the correct way to dispose of them, I received terrible advice. A pharmacist bent the needle to 120 degrees. “We’ll do that,” he told me. The sharp point was obviously still exposed. “In the sewer, on the street,” said another pharmacist when I asked him where to throw the needle before I tossed it out the window without looking. I watched the needle float in a puddle of open sewage. Children were hopping around the corner down the street.

At the time, Rajesh Panjwani was the Sindh HealthCare Commission’s deputy director of inspections for the Larkana area, which also includes Ratodero. I managed to see him. He shared an office with Faraz Hussain, an administrator; Their desks were at right angles to each other. “All hospitals use the safety boxes,” Panjwani assured me, referring to sharp rubbish bins. I told him I didn’t see this, but he denied my characterization. We walked back and forth until he had to take a call. I didn’t even know that Hussain was listening as he was typing briskly on a large desktop computer, but now he was speaking. “They’re 100 percent telling the truth about government hospitals,” he told me.

Panjwani later told me that he had inspected many clinics in the area and that they had security boxes available. I said I hadn’t seen a safe in any of the dozen or so clinics I went to. At that point, Hussain said something to Panjwani and they started arguing in Sindhi. My translator said to me softly: “Hussain says: ‘She is telling the truth. Please admit the truth. There are no safety boxes in the clinics. ‘”

Everything, it seems, is always someone else’s job. Aftab Ahmad, a doctor in charge of monitoring and evaluating the Sindh AIDS Control Program, blamed the district health bureau for the outbreak. “There is a refusal, you are right,” said Ahmad. “People don’t quite do what they’re supposed to do.” The Sindh HealthCare Commission can order a clinic to be sealed, but is asking the police to enforce the order. The commission considers its job to be done when it has issued its recommendation to close clinics with violations. The Commission does not see itself responsible for actually closing the facilities or for ensuring that they remain closed.

The cruel dilemma, however, is that without these private health rooms, many people in Ratodero and other remote areas of Pakistan would not have access to medical care. For the poor and the uneducated, there is usually a choice between terrible care or no care at all.

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Health

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia Scraps Covid-19 Vaccine That Produced H.I.V. False Positives

Australia on Friday canceled a roughly $ 750 million plan for a major contract for a locally developed coronavirus vaccine after vaccination resulted in false positive test results for HIV in some volunteers participating in an experimental study.

Of the dozen of coronavirus vaccines tested worldwide, the Australian one was the first to be abandoned. While the developers said the experimental vaccine was safe and effective, the false positives risked confidence in efforts to vaccinate the public.

Prime Minister Scott Morrison said Friday that his government would partially offset the loss of 51 million doses it planned to buy from the Australian consortium by increasing orders for vaccines from AstraZeneca and Novavax. The government has announced that it will start vaccinating citizens in March.

“We can’t have problems with trust,” he told reporters, “and now as a nation with a good portfolio of vaccines we are able to make those choices to best protect the Australian people.”

The Australian setback highlighted the missteps that can inevitably occur when scientists shorten the usual year-long process of vaccine development to a few months during a pandemic that killed more than 1.5 million people.

But just as the Australian scientists made their announcement, the fruits of this breed became clearer. The United States got one step closer to getting its first approval for a Covid-19 vaccine when a panel of experts advising the Food and Drug Administration endorsed a Pfizer vaccine that is already in use in the UK.

The problem with the Australian vaccine, developed by the University of Queensland and biotech company CSL, was related to the use of two fragments of a protein found in HIV

The protein was part of a molecular “clamp” that researchers placed on the spikes surrounding the coronavirus and allowed it to penetrate healthy cells. The bracket stabilizes the spikes and allows the immune system to respond more effectively to the vaccine.

Using the HIV protein did not pose a risk of infecting the volunteers with this virus, the researchers said. However, the clamp produced the production of antibodies that were detected by HIV testing at higher levels than scientists expected.

Because HIV tests couldn’t be quickly revised to take this into account, the researchers decided to stop developing the vaccine. The act could have created widespread fears among Australians that the vaccine could cause AIDS.

Early experiments on hamsters showed that the vaccine protected them from the coronavirus. When Phase 1 human trials began in July, the 216 volunteers were “fully informed about the possibility of a partial immune response” to the clamp, the University of Queensland and CSL said in a statement Friday.

Updated

Apr 11, 2020 at 1:26 am ET

The mistake, said John P. Moore, an immunologist at Weill Cornell Medical College in New York, was an “honest mistake” that cost money, not human life.

“I’m sure a lot of people are very embarrassed,” said Professor Moore. “It’s not great to be associated with a bug like this. But when you run at 90 mph, you sometimes trip. “

The coronavirus outbreak>

Things to know about testing

Confused by Coronavirus Testing Conditions? Let us help:

    • antibody: A protein produced by the immune system that can recognize and attach to certain types of viruses, bacteria or other invaders.
    • Antibody test / serology test: A test that detects antibodies specific to the coronavirus. About a week after the coronavirus infects the body, antibodies start appearing in the blood. Because antibodies take so long to develop, an antibody test cannot reliably diagnose an ongoing infection. However, it can identify people who have been exposed to the coronavirus in the past.
    • Antigen test: This test detects parts of coronavirus proteins called antigens. Antigen tests are quick and only take five minutes. However, they are less accurate than tests that detect genetic material from the virus.
    • Coronavirus: Any virus that belongs to the Orthocoronavirinae virus family. The coronavirus that causes Covid-19 is known as SARS-CoV-2.
    • Covid19: The disease caused by the new coronavirus. The name stands for Coronavirus Disease 2019.
    • Isolation and quarantine: Isolation is separating people who know they have a contagious disease from those who are not sick. Quarantine refers to restricting the movement of people who have been exposed to a virus.
    • Nasopharyngeal smear: A long, flexible stick with a soft swab that is inserted deep into the nose to collect samples from the space where the nasal cavity meets the throat. Samples for coronavirus tests can also be obtained with swabs that do not go as deep into the nose – sometimes called nasal swabs – or with mouth or throat swabs.
    • Polymerase chain reaction (PCR): Scientists use PCR to make millions of copies of genetic material in a sample. With the help of PCR tests, researchers can detect the coronavirus even when it is scarce.
    • Viral load: The amount of virus in a person’s body. In people infected with the coronavirus, viral loads can peak before symptoms, if any.

The University of Queensland’s vaccine was one of several vaccines under development that contain a coronavirus protein that triggers an immune system response. Protein-based vaccines have a longer track record than some of the newer approaches used by competing coronavirus vaccines, such as those based on viral genes or called adenoviruses.

Prominent protein-based vaccines include one from Novavax of Maryland, which is in Phase 3 trials, and another from Clover Biopharmaceuticals of China, which is in Phase 1.

In the case of the Australian vaccine, it was found to produce a strong immune response and, according to the scientists in the phase 1 study, did not cause any serious side effects. However, proceeding with the vaccine study would have required “significant changes” in longstanding HIV testing procedures, they said.

“This would delay development for another 12 months, and while this is a difficult decision, the urgent need for a vaccine must be everyone’s priority,” Paul Young, a virologist at the university who directed the vaccine effort, said in the Explanation. He did not immediately respond to a request for comment on Friday afternoon.

Australian Health Secretary Greg Hunt told reporters the country still has access to 140 million units of coronavirus vaccines – more than enough to feed its population of approximately 25 million people.

“This is the scientific process that works,” said Hunt. “It’s the planning process that works. It’s an honest explanation for some of the challenges we’ve faced. “

Carl Zimmer contributed to the reporting.