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J&J’s HIV Vaccine Fails to Protect High-Risk African Women in Trial

Johnson & Johnson announced that the company’s Imbokodo Phase IIb trial in HIV failed to hit the primary endpoint. The study evaluated J&J’s investigational HIV vaccine regimen in young women in sub-Saharan Africa at high risk of acquiring …

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J&J’s HIV Vaccine Fails to Protect High-Risk African Women in Trial

Published: Aug. 31, 2021

By Mark Terry

BioSpace

 

Johnson & Johnson announced that its Imbokodo Phase IIb trial in HIV failed to hit the primary endpoint. The study evaluated the company’s investigational HIV vaccine regimen in young women in sub-Saharan Africa at high risk of acquiring HIV. It did not provide sufficient protection against HIV. The virus uses an adenovirus design that the company also uses for its COVID-19 vaccine.

As a result of the analysis, the Imbokodo trial will not continue. In parallel with the trial, Janssen, a Johnson & Johnson company, is sponsoring the ongoing Phase III Mosaico trial, evaluating a different composition of the HIV vaccine regimen in men who have sex with men (MSM) and transgender individuals. The Mosaico trial is being run in the Americas and Europe, where, the company notes, there are different strains of HIV circulating than in sub-Saharan Africa. After consulting with the Mosaico study’s independent Data and Safety Monitoring Board (DSMB), the company decided Mosaico will continue.

“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” said Paul Stoffels, M.D., vice chairman of the Executive Committee and chief scientific officer at Johnson & Johnson. “HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system.”

He went on to say, “While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV. We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus.”

The Imbokodo Phase IIb trial was a proof-of-concept efficacy study. It began in 2017, was fully enrolled in 2019, and completed dosing on June 30, 2020. It enrolled about 2,600 young women in five countries in sub-Saharan Africa. There were 23 trial sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe.

The study was supported by a public-private partnership led by Janssen Vaccines & Prevention BV, part of the Janssen Pharmaceutical Companies of J&J. It included the National Institute of Allergy and Infectious Disease (NIAID), the Bill & Melinda Gates Foundation and the HIV Vaccine Trials Network (HVTN). Additional partners that offered support included the U.S. Army Medical Research and Development Command (USAMRDC) and the Ragon Institute of MGH, MIT and Harvard. The South African Medical Research Council (SAMRC) handled implementation in South Africa.

Michael Vi/Shutterstock

Imbokodo treated participants with four vaccination visits over one year. Then primary analysis was performed 24 months after they received their first shots. The primary endpoint is based on the difference in the number of new HIV infections in placebo versus vaccine groups from month seven through month 24. At the 24-month mark, 63 of 1,109 participants who received placebo acquired HIV compared to 51 of 1,079 in the vaccine group. This had a vaccine efficacy estimate of 25.2%. The vaccine was safe and well-tolerated.

“This high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region,” said Glenda Gray, president and chief executive officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol chair. “This underscores the need to apply the knowledge that will be gained from this trial to continue to advance the pursuit of a global HIV vaccine.”

 

BioSpace source:

https://www.biospace.com/article/johnson-and-johnson-s-hiv-vaccine-flunks-imbokodo-trial-in-sub-saharan-african-women

 

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Government

Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted…

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September 22, 2023

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Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes

Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted in New York for allegedly accepting bribes in relation to an allegedly corrupt relationship they had with three businessmen from their home state. The indictment also charges three businessmen, Wael Hana, Jose Uribe and Fred Daibes.

"Those bribes included cash, gold, payments toward a home mortgage, compensation for a low-or-no-show job, a luxury vehicle, and other things of value," reads the indictment.

Daibes, a developer and former bank chairman, allegedly gave Menendez gold bars valued at approximately $400,000, in exchange for assistance in a case in which he faced federal bank charges.

Instead of facing over 10 years in prison, Daibes, a felon, only ended up serving probation after striking an agreement with the US Attorney's Office in New Jersey.

"For purposes of the Federal Extortion Act, it makes no difference if the senator took an official act so long as he accepted the money and there was knowledge the money was in exchange for that official influence, even if he never carried out what he had promised he would do," according to NBC Legal Analyst Danny Cevallos.

Menendez disclosed that his family had accepted gold bars in 2020. Daibes encountered bank fraud charges that could have netted him up to a decade in prison for lying about a nearly $2 million loan from Mariner's Bank, where Daibes served as chairman.

Last year, however, New Jersey's U.S. Attorney's Office agreed to let Daibes plead guilty to one count and serve probation. They said Daibes had repaid the loan. -Fox News

According to the report, Menendez, 69, is 'close' with US Attorney Philip Sellinger - having supported him for the position, while Sellinger had previously raised funds for Menendez's campaign.

Bob Menendez and wife Nadine

Officials are also looking at whether Menendez, the former Chairman of the powerful Senate Foreign Relations Committee, or his wife, had improperly received gifts from a New Jersey food processor who obtained an exclusive contract with the Egyptian government to certify halal food experts around the world.

Egyptian officials and the New Jersey businessman who received the contract were hosted by Menendez in his office in 2018, according to the Wall Street Journal. A year later, the businessman became the "sole certifier of halal meat exported from the U.S. to Egypt," the outlet noted.

NBC News 4 said the gifts included the usage of a Mercedes and a luxury Washington, D.C., apartment. Investigators are attempting to resolve if Menendez, chair of the Senate Foreign Relations Committee, used his standing to help the man secure the contract. -Fox News

According to the indictment, Menendez provided 'sensitive US Government information to Egypt.'

Menendez and his wife are charged with three counts: conspiracy to commit bribery, conspiracy to commit honest services fraud, and conspiracy to commit extortion under color of official right.

In June of last year, federal agents searched Menendez's New Jersey home, where they found "fruits" of the pair's "corrupt bribery agreement" with the three businessman - including over $480,000 in cash, some of which was stuffed in envelopes, and $70,000 in Nadine Menendez's safe deposit box.

They also found gold bars worth over $100,000, "provided by either Hana or Daibes."

In the months before his office admitted he was under federal investigation, Menendez's wife sold up to $400,000 in gold bars between April 7, 2022 and June 16, 2022.

This is hardly the first time Menendez has been under federal criminal investigation.

Tyler Durden Fri, 09/22/2023 - 09:30

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Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with…

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September 22, 2023

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Zelensky Departs Washington Mostly Empty-Handed Amid Mood Shift In West

By all accounts, Zelensky came away from his Washington visit with nothing new. Biden did announce a fresh $325 million aid package for Ukraine from already committed funds, but the hoped-for long range missile approval never came (however, more cluster bombs are being sent). And as we detailed Thursday, House Republican leadership once again failed to move forward on a mere procedural vote for the Pentagon funding bill, due in large part to GOP members rejecting Biden's proposed $24 billion more in Ukraine aid.

Thursday's package announced by Biden, as Zelensky visited the White House and Capitol Hill, was run-of-the-mill and entirely to be expected. "Today I approved the next tranche of U.S. security assistance to Ukraine including more artillery, more ammunition, more anti-tank weapons and next week, the first U.S. Abrams tanks will be delivered to Ukraine," Biden said.

As for the earlier in the day (Thurs.) meeting with Congressional leaders, House Speaker Kevin McCarthy explained when asked why the Ukrainian leader's request to address Congress was denied, "Zelensky asked for a joint session, we just didn't have time. He's already given a joint session."

Via AFP

Instead in a closed-door meeting, Zelensky later acknowledged he discussed with lawmakers "the battlefield situation and priority defense needs."

But if there is any level of consolation for Kiev, it's seen in the Pentagon announcement which came late in the day Thursday. Facing potential US government shutdown on Oct.1st, given at this point Congress is not expected to pass the 12 appropriations bills needed to fund government operations before next fiscal year, the Pentagon has said it will exempt its operations supporting Ukraine from a shutdown. 

The military typically suspends any activities not deemed vital to national security during government shutdowns, thus the DoD is in effect saying Ukraine aid remains "vital to national security". 

"Operation Atlantic Resolve is an excepted activity under a government lapse in appropriations," Pentagon spokesman Chris Sherwood told Politico, in reference to the operational name still used for actions supporting Kiev.

But Politico points out a potential shutdown would still negatively impact US support to Ukraine:

Sherwood noted that while DOD’s activities related to Ukraine will continue, furloughs and other activities halted under the shutdown could still have a negative impact.

"Training would happen, but depending on whether or not there were certain personnel that were not able to report for duty, for example, that could have an impact," said Pentagon spokesperson Brig. Gen. Patrick Ryder on Thursday.

This Pentagon exemption to keep Ukraine-related support active during a government shutdown seems to be the only significant thing Zelensky came away with. 

It appears to have been the main object of discussion when Zelensky met with Secretary of Defense Lloyd Austin in Washington during the trip. The Pentagon said this was "to reaffirm the steadfast US support for Ukraine."

Meanwhile, Bloomberg takes note of Zelensky "showing the strain" amid increasing divisions among allies:

The Ukrainian president allowed a dispute with one of his biggest allies to spin out of control at the United Nations General Assembly this week, and that’s just a hint of the tensions building behind the scenes.

Zelenskiy has been leading his country through Russia’s brutal assault for 19 months, all the time fighting on another front to wring the weapons and finance he needs from his US and European supporters. Now he suspects that President Joe Biden’s commitment is wavering and other leaders may be taking their cue from the US, according to a person who met with him recently.

He grew very emotional at times during that discussion, the person said, and was scathing in his criticism of nations that he said weren’t delivering weapons quickly enough.

Washington's lackluster greeting of Zelensky this week (compared to how he was received in December 2022) came simultaneous to Poland declaring it will no longer arm Ukraine, amid a fierce diplomatic spat over blockage of Ukraine grain imports by Warsaw, to protect Polish farmers.

The Economist is also taking note of the significant mood shift among Western allies...

A "long war" indeed... given a G7 leader from a European country has told reporters this week that the West is prepared for a years-long war, something likely to last some six or seven years, according to the quote.

"A senior official from one European G-7 country said the war may last as much as six or seven more years and that allies need to plan financially to continue support for Kyiv for such a long conflict," Bloomberg wrote.

Tyler Durden Fri, 09/22/2023 - 10:15

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International

Michael Bloomberg puts up $500M to shut down this controversial industry

The businessman and former New York City mayor is investing big money for a high-powered campaign.

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30 mins ago

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September 22, 2023

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Years ago, a rich person or company would indicate wealth by donating libraries and orphanages or traverse the world in bespoke yachts or aircraft.

You may commission a boat to extract an enemy submarine off the depths of the ocean floor. Perhaps you'd get an ivy league school of public policy and government named in your honor. If you were really industrious, you might even gather a bunch of your high-powered banker friends in a locked room on a distant island off the coast of Georgia to establish what we now call the Federal Reserve. 

DON'T MISS: China is no longer the leading exporter to U.S. (here's who is)

Nowadays, however, it's quite in vogue to gather large stockpiles of your cash and put it to work not for your people or your country. Billionaires think much bigger than that. If you're really rich, you put your money to work for the good of planet Earth. 

Take, for example, Microsoft  (MSFT) - Get Free Report and Amazon  (AMZN) - Get Free Report, who both recently pledged hundreds of millions of dollars between the two to capture carbon out of the atmosphere and dispose of it where it may no longer be accessed. 

Businessman and former New York City Mayor Michael Bloomberg is the latest billionaire to take a stab at the seemingly unsolvable climate crisis – and he's putting a vast sum of his money up to the challenge. 

Aerial view of Jon Amos Power plant shows smoke stacks and cooling, Coal, Poca, West Virginia. (Photo by: Visions of America/Joseph Sohm/Universal Images Group via Getty Images)

Joe Sohm/Visions of America/Getty Images

Michael Bloomberg pledges millions to fight coal

Bloomberg's charitable organization, Bloomberg Philanthropies, announced on Wednesday that it would front $500 million to shut down all existing coal plants in the U.S. and prevent future natural gas plants from being constructed. 

The pledge may sound anti-industrialist, but Bloomberg's "Beyond Carbon" initiative claims it will "turbocharge," environmental progress. 

The initiative includes the following bullet points: 

  • Finish the job on coal. With 372 of 530 coal plants announced to retire or closed to date – more than 70 percent of the country’s coal fleet – this next phase will shut down every last U.S. coal plant.
  • Slash gas plant capacity in half, and block all new gas plants.
  • Increase U.S. clean energy four-fold. Accelerate the clean energy transition to reach the goal of 80 percent of total electricity generation.

"Bloomberg Philanthropies has helped retire more than 70 percent of all U.S. coal plants, which accounts for more than 80 percent of all emissions reductions in the United States since 2010," Bloomberg, who's a special envoy on climate ambition and solutions to the U.N. proudly announced on Wednesday. 

Beyond Carbon will also fund the following organizations as a part of its mission toward progress: 

  • Earthjustice
  • Hip Hop Caucus
  • Sierra Club
  • RMI
  • League of Conservation Voters
  • Advanced Energy United
  • Coalfield Development

No stranger to controversy, Bloomberg has supported a number of divisive policies during his tenure in the public eye, including calls for banning polystyrene foam that is commercially known as Styrofoam, smoking, trans fats, and restricting sugary drinks in some public businesses. 

Now, it seems the billionaire is more concerned about climate change as a threat to public health than fat or soda. 

"This work has helped achieve more than 80 percent of all U.S. emissions reductions since 2010 and plant closures from the campaigns are estimated to have saved 49,900 lives, prevented nearly 77,500 heart attacks, and saved billions in healthcare costs," Bloomberg Philanthropies writes.

"But the U.S. is now at a pivotal moment — without rapid progress on clean energy, we will fail to meet our U.S. climate targets, and public health risks will skyrocket. Beyond Carbon’s next phase will ensure the U.S. delivers on our global climate commitments by retiring the last remaining coal plants, stopping the expansion of natural gas, and quadrupling clean energy capacity while continuing to prioritize environmental justice and workforce transition."

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