“The [trial] will enroll 5,400 HIV-uninfected men and women ages 18-35 at risk for HIV infection at 15 clinical research sites. NIAID and BMGF are funding the US$130 million trial.” – U.S. Agency for International Development (USAID), 2016 [That’s over $24,00 per person to facilitate high-risk sex acts, specifically anal copulation. –Ed.]
NIH discontinues vaccinations in Africa after 252 participants get HIV during trial |
Feb 3, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has stopped administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine.
This action was taken because an independent data and safety monitoring board (DSMB) found during an interim review that the regimen did not prevent HIV.
Importantly, the DSMB did not express any concern regarding participant safety.
The Phase 2b/3 study, named HVTN 702 or Uhambo, began in 2016 and is taking place in South Africa. [The same nation took offense when Donald Trump referered to unspecified African nations as ‘shithole countries; see below.]
“If you don’t have HIV, being a receptive partner (or bottom) for anal sex is the highest-risk sexual activity for getting HIV. If you do have HIV, being the insertive partner (or top) for anal sex is the highest-risk sexual activity for transmitting HIV.” – Minority HIV/AIDS Fund, an official U.S. Government website managed by the U.S. Department of Health & Human Services
It was testing an investigational prime-boost vaccine regimen based on the only vaccine regimen ever to show protection from HIV—the regimen tested in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health.
For HVTN 702, the vaccine regimen was adapted to the HIV subtype Clade C most common in southern Africa, where the pandemic is most pervasive.
“An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work. Regrettably, it does not,” said NIAID Director Anthony S. Fauci, M.D. “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved.”
The HVTN 702 study enrolled 5,407 HIV-negative volunteers at 14 sites across South Africa. The study population consisted of sexually active men and women aged 18 to 35 years. The study volunteers were randomly assigned to receive either the investigational vaccine regimen or placebo injections.
Study participants received six injections over 18 months. As with all NIAID-sponsored HIV prevention trials, the safety of HVTN 702 study participants was closely monitored throughout the trial, and participants were offered the local standard of care for preventing HIV, including access to oral pre-exposure prophylaxis (PrEP).
In the January 23, 2020 interim analysis, the DSMB examined data from 2,694 volunteers who received the investigational vaccine regimen and 2,689 volunteers who received the placebo injection. (Coverage contines below … )
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The analysis looked at how many participants were diagnosed with HIV after at least 60% of the participants had been in the study for more than 18 months — enough time for the vaccine regimen to stimulate an immune response.
In this analysis, 129 HIV infections occurred among the vaccine recipients, and 123 HIV infections occurred among the placebo recipients.
Based on these findings, the DSMB concluded that the investigational vaccines had not shown any efficacy. The DSMB recommended that no further vaccinations be administered and that participants remain in the study for follow-up.
The report noted there was no significant evidence of either decreased or increased infection rates with vaccination.
NIAID, the trial sponsor, concurred with the DSMB’s recommendation, and stopped the vaccinations. Participants are being informed, and study investigators will continue following study participants over time.
“The people of South Africa have made history by answering this important scientific question. Sadly, we wish the answer was different,” said HVTN 702 Protocol Chair Glenda Gray, M.B.B.C.H., F.C.Paed. (SA).
“We will continue to explore promising avenues for preventing HIV with other vaccines and tools, both in South Africa and around the world.”
Dr. Gray is president and chief executive officer of the South African Medical Research Council; research professor of pediatrics at the University of the Witwatersrand, Johannesburg; and a founding director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa.
NIH is investing in multiple approaches to prevent HIV with the goal of delivering new options that are safe, effective, desirable to diverse populations, and scalable worldwide to help end the global pandemic.
These efforts include two other late-stage, multinational vaccine trials, Imbokodo and Mosaico, both testing a novel mosaic vaccine regimen and being sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The vaccine concept being tested in these trials is different than the one under investigation in HVTN 702.
In addition, the proof-of-concept AMP trials are testing an intravenously delivered investigational antibody for preventing HIV. Other cutting-edge studies, including the AMP trials, are investigating if broadly neutralizing antibodies (bNAbs) can protect against HIV.
Two other large-scale trials are testing an investigational long-acting injectable antiretroviral drug, cabotegravir, for HIV prevention. Additional novel, long-acting HIV prevention products are also under study, including implants, vaginal rings, combinations of bNAbs, and multi-purpose products that offer contraception along with HIV prevention.
The HVTN 702 vaccine regimen consisted of two experimental vaccines: a canarypox vector-based vaccine called ALVAC-HIV and a two-component gp120 protein subunit vaccine with an adjuvant to enhance the body’s immune response to the vaccine.
Both ALVAC-HIV (supplied by Sanofi Pasteur) and the protein vaccine (supplied by GSK) were modified from the versions used in RV144 to be specific to HIV subtype C.
Additionally, the protein subunit vaccine in HVTN 702 was combined with MF59, a different adjuvant than the one used in RV144, in the hope of generating a more robust and durable immune response.
Finally, the HVTN 702 vaccine regimen included booster shots at the one-year and 18-month timepoints in an effort to prolong the early protective effect observed in RV144.
HVTN 100, a predecessor clinical trial using the HVTN 702 regimen, found that the new vaccine regimen was safe and induced high and boostable titers of antibodies to several HIV strains prevalent in southern Africa.
South Africa has one of the highest HIV rates in the world. According to UNAIDS, more than 20% of the adult population ages 15-49 in South Africa are living with HIV, and 240,000 people acquired HIV in 2018.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services.
NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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South Africa formally protests Trump’s ‘shithole countries’ remarks
Jan 15, 2018
Johannesburg (CNN)South Africa issued a diplomatic protest to the United States Monday over President Donald Trump’s “shithole countries” comments, according to its foreign ministry.
South African diplomats also met with the US Embassy’s Charge d’Affaires Monday to express their concerns.
In a statement, the South African Department of International Relations and Cooperation (DIRCO) didn’t specifically mention the vulgarity but said it was concerned about “statements that were allegedly made by President Donald Trump” concerning African nations.
DIRCO noted South Africa’s contributions to the United States and said international reactions “clearly serve as a united affirmation of the dignity of the people of Africa and the African diaspora.” The statement also noted that Monday was Martin Luther King Day in the United States.