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Global HIV vaccine trial ends in disappointment

Experimental vaccine called safe but ineffective

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A worldwide trial of an experimental HIV vaccine involving 3,900 volunteers resulted in disappointment. (Image of HIV courtesy of the NIH)

A worldwide clinical trial of an experimental HIV vaccine involving 3,900 volunteer men who have sex with men and transgender people that some researchers were hopeful would finally result in an effective HIV vaccine was found to be safe but ineffective in preventing HIV infection.

According to a Jan. 18 statement released by the U.S. National Institute of Allergy and Infectious Diseases, which partially funded and helped organize the trial, the vaccine trial is being discontinued and participants were being notified of the findings, with further analysis of the study data planned.

The NIAID statement says the Janssen pharmaceutical company developed the experimental vaccine based on what researchers call ā€œmosaicā€ immunogens or vaccine components featuring elements of multiple HIV subtypes. It says the goal was to induce immune responses against a wide variety of global HIV strains.

The statement says the investigational vaccine regimen consisted of four injections over a period of one year for the volunteers, who were based in the U.S., Latin America, and Europe. It says an independent data and safety monitoring board, referred to as DSMB, analyzed the data obtained from the vaccine trial, which began in 2019.

ā€œIn its scheduled data review, the DSMB determined there were no safety issues with the experimental vaccine regimen,ā€ the statement says. ā€œHowever, the number of HIV infections were equivalent between the vaccine and placebo arms of the study,ā€ the statement continues. ā€œDuring the clinical trial, all participants were offered comprehensive HIV prevention tools, including pre-exposure prophylaxis or PrEP,ā€ it says.

ā€œStudy staff ensured that participants who acquired HIV during the trial were promptly referred for medical care and treatment,ā€ according to the NIAID statement.

The NIAID study findings prompted the United Nations Program on HIV/AIDS, known as UNAIDS, to issue its own statement this week calling for the aggressive deployment of existing HIV prevention and treatment options as efforts to develop a vaccine continue.

ā€œThe disappointment of the vaccine trial further underlies the importance of rolling out available HIV treatment and prevention innovations, including oral PrEP, long acting injectables and the vaginal ring,ā€ UNAIDS Executive Director Winnie Byanyima said in the UNAIDS statement.

ā€œThe research for a vaccine must continue, but itā€™s important to remember that despite this setback the world can still end AIDS by 2030 by delivering all the proven prevention and treatment options to all people who need them,ā€ she said.

ā€œGlobal research efforts into vaccines and a cure must carry on,ā€ the UNAIDS statement says. ā€œAt the same time, the world cannot wait for, or depend on, a vaccine or cure. The end of AIDS by 2030, as promised, is still possible, but leaders have no time to wait.ā€

An organization called the Global Advocacy for HIV Prevention, which keeps track of HIV vaccine studies, shows on its website that at least a dozen other HIV experimental vaccine trials are currently taking place in the U.S., Latin American, Europe, and Africa. Two of them in the U.S. are being sponsored by the Bill and Melinda Gates Foundation, the website shows.

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Commentary

Journalists are not the enemy

Wednesday marks five years since Blade reporter detained in Cuba

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The Hungarian Parliament in Budapest, Hungary, on April 4, 2024. Prime Minister Viktor OrbƔn and his government over the last decade has cracked down on the country's independent media. (Washington Blade photo by Michael K. Lavers)

Wednesday marked five years since the Cuban government detained me at Havana’s JosĆ© Marti International Airport.

I had tried to enter the country in order to continue the Washington Blade’s coverage of LGBTQ and intersex Cubans. I found myself instead unable to leave the customs hall until an airport employee escorted me onto an American Airlines flight back to Miami.

This unfortunate encounter with the Cuban regime made national news. The State Department also noted it in its 2020 human rights report.

Press freedom and a journalist’s ability to do their job without persecution have always been important to me. They became even more personal to me on May 8, 2019, when the Cuban government for whatever reason decided not to allow me into the country.  

Washington Blade International News Editor Michael K. Lavers after the Cuban government detained him at Havana’s JosĆ© Marti International Airport on May 8, 2019. (Washington Blade photo by Michael K. Lavers)

‘A free press matters now more than ever’

Journalists in the U.S. and around the world on May 3 marked World Press Freedom Day.

Reporters without Borders in its 2024 World Press Freedom Index notes that in Cuba “arrests, arbitrary detentions, threats of imprisonment, persecution and harassment, illegal raids on homes, confiscation, and destruction of equipment ā€” all this awaits journalists who do not toe the Cuban Communist Party line.” 

“The authorities also control foreign journalistsā€™ coverage by granting accreditation selectively, and by expelling those considered ‘too negative’ about the government,” adds Reporters without Borders.

Cuba is certainly not the only country in which journalists face persecution or even death while doing their jobs.

ā€¢ Reporters without Borders notes “more than 100 Palestinian reporters have been killed by the Israel Defense Forces, including at least 22 in the course of their work” in the Gaza Strip since Hamas launched its surprise attack against Israel on Oct. 7, 2023. Media groups have also criticized the Israeli government’s decision earlier this month to close Al Jazeera’s offices in the country.

ā€¢ Wall Street Journal reporter Evan Gershkovich, Washington Post contributor and Russian opposition figure Vladimir Kara-Murza and Radio Free Europe/Radio Liberty’s Alsu Kurmasheva remain in Russian custody. Austin Tice, a freelance journalist who contributes to the Post, was kidnapped in Syria in August 2012.

ā€¢ Reporters without Borders indicates nearly 150 journalists have been murdered in Mexico since 2000, and 28 others have disappeared.

The Nahal Oz border crossing between Israel and the Gaza Strip on Nov. 21, 2016. Reporters without Borders notes the Israel Defense Forces have killed more than 100 Palestinian reporters in the enclave since Hamas launched its surprise attack against Israel on Oct. 7, 2023. (Washington Blade photo by Michael K. Lavers)

Secretary of State Antony Blinken in his World Press Freedom Day notes more journalists were killed in 2023 “than in any year in recent memory.”

“Authoritarian governments and non-state actors continue to use disinformation and propaganda to undermine social discourse and impede journalistsā€™ efforts to inform the public, hold governments accountable, and bring the truth to light,” he said. “Governments that fear truthful reporting have proved willing to target individual journalists, including through the misuse of commercial spyware and other surveillance technologies.”

U.S. Agency for International Development Administrator Samantha Power, who is a former journalist, in her World Press Freedom Day statement noted journalists “are more essential than ever to safeguarding democratic values.” 

“From those employed by international media organizations to those working for local newspapers, courageous journalists all over the world help shine a light on corruption, encourage civic engagement, and hold governments accountable,” she said.

President Joe Biden echoed these points when he spoke at the White House Correspondents’ Association Dinner here in D.C. on April. 27.

“There are some who call you the ‘enemy of the people,'” he said. “Thatā€™s wrong, and itā€™s dangerous. You literally risk your lives doing your job.”

I wrote in last year’sĀ World Press Freedom Day op-edĀ that the “rhetoric ā€” ‘fake news’ and journalists are the ‘enemy of the people’ ā€”Ā thatĀ the previous president and his followers continue to use in order to advance an agenda based on transphobia, homophobia, misogyny, islamophobia, and white supremacyĀ has placed American journalists at increased risk.” I also wrote the “current reality in which we media professionals are working should not be the case in a country that has enshrined a free press in its constitution.”

“A free press matters now more than ever,” I concluded.

That sentiment is even more important today.

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Health

MISTR announces itā€™s now prescribing DoxyPE

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MISTR, the telemedicine provider that offers free online PrEP and long-term HIV care in all 50 states, D.C., and Puerto Rico, announced it is now prescribing Doxycycline Post-Exposure Prophylaxis (DoxyPEP), an antibiotic that reduces bacterial STIs, including gonorrhea, chlamydia, and syphilis. Patients can now use MISTRā€™s telehealth platform to receive DoxyPEP online for free, according to a release from the company.

With this launch, MISTR plans to offer patients access to post-exposure care, in addition to its existing preventive and long-term HIV treatment options, which include PrEP and antiretroviral therapy (ART). This comes at a time when the rate of STIs continue to rise. In 2022, more than 2.5 million cases of syphilis, gonorrhea, and chlamydia were reported in the U.S; of that population, gay and bisexual men are disproportionately affected, the company reported.

ā€œDespite an ongoing STI epidemic affecting the LGBTQ+ community, there are few resources available for this underserved, vulnerable community to get the preventative medication they need,ā€ said Tristan Schukraft, CEO and founder of MISTR. ā€œIā€™m proud that MISTR is democratizing access to PrEP, HIV care, and now DoxyPEP.ā€

An NIH-funded study published by the New England Journal of Medicine in April 2023 found that doxycycline as post-exposure prophylaxis, now known as DoxyPEP, reduced syphilis by 87%, chlamydia by 88%, and gonorrhea by 55% in individuals taking HIV PrEP, and reduced syphilis by 77%, chlamydia by 74% and gonorrhea by 57% in people living with HIV. 

MISTR is a telemedicine platform offering free online access to pre-exposure prophylaxis (PrEP) and long-term HIV care Visit mistr.com for more information.

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Health

UNAIDS to commemorate Zero Discrimination Dayā€™s 10th anniversary

UN agency urges global action to protect human rights

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A UNAIDS anti-discrimination exhibit at Tocumen International Airport in Panama in 2018. (Washington Blade photo by Michael K. Lavers)

As the world marks the 10th anniversary of Zero Discrimination Day; UNAIDS is sounding the alarm on the increasing threats to human rights, calling for renewed efforts to protect the rights of all individuals as a fundamental step towards ensuring health for everyone.

Established by UNAIDS a decade ago, Zero Discrimination Day aims to promote equality and fairness regardless of gender, age, sexuality, ethnicity or HIV status. The progress achieved over the past years is now in jeopardy, however, due to rising attacks on the rights of women, LGBTQ people and other marginalized communities.

UNAIDS Executive Director Winnie Byanyima emphasized the critical link between protecting human rights and safeguarding public health. 

“The attacks on rights are a threat to freedom and democracy and are harmful to health,ā€ she said in a press release. ā€œStigma and discrimination obstruct HIV prevention, testing, treatment and care and hold back progress towards ending AIDS by 2030. It is only by protecting everyoneā€™s rights that we can protect everyoneā€™s health.”

Despite challenges, there has been notable progress. 

At the onset of the AIDS pandemic more than 40 years ago, two-thirds of countries criminalized consensual same-sex sexual relations. They are now decriminalized in two-thirds of countries. An additional 38 countries around the world have pledged to end HIV-related stigma and discrimination, contributing to positive changes that include 50 million more girls attending school compared to 2015.

To sustain and enhance these advancements; UNAIDS urges global support for womenā€™s rights movements, LGBTQ rights, racial justice, economic justice, climate justice and peace initiatives. By standing with communities advocating for their rights, the U.N. aims to reinforce the collective effort towards a more inclusive and equitable world.

Zero Discrimination Day is observed on March 1.

Events and activities that will take place around the world throughout the month will serve as reminders of the essential lesson and call to action: Protecting everyoneā€™s health is synonymous with protecting everyoneā€™s rights.

“Through upholding rights for all, we will be able to achieve the Sustainable Development Goals and secure a safer, fairer, kinder and happier world ā€” for everyone,” said Byanyima.

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