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HIV vaccine fails

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What was billed to be a major leap in the fight against HIV and Aids just got crushed after more people than expected contracted the virus.

An investigational HIV vaccine failed to provide sufficient protection against the virus in a population of young women at risk of acquiring HIV in Malawi and four other countries, The Sunday Times has learnt. The trial involved more than 2,600 young women at 23 sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe.

With its efficacy in preventing HIV infection at just over 25 percent, the trial, which began in 2017, has been halted.

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Researchers reportedly found that 63 out of 1,109 participants who received the placebo—treatment which is designed to have no therapeutic value — and 51 out of 1,079 who received the vaccine
became infected with HIV.

A statement from Johnson & Johnson (J&J), who made the vaccine, and partners, says participants who were infected with HIV in the study—dubbed Imbokodo, a Zulu word meaning ‘a rock’—were
referred to “high-quality HIV treatment and care services”.

“Study participants will be notified of the results, unblinded and informed whether they were in the study group who received the vaccine or the group who received placebo,” the statement says.

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It quotes a chief scientific officer at J&J Paul Stoffels as having said the company will continue
conducting research against HIV.

“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,” Stoffels said.

The investigational vaccine was reportedly found to have a favourable safety profile with no serious adverse events.

In an interview yesterday, Ministry of Health acting Director of Research Dr. Collins Mitambo said Malawi
will continue exploring potential HIV vaccines.

He also disclosed that the Malawi study team will inform the Ethics Committee in the ministry that they are no
longer conducting the investigation.

“When something like this happens, we expect that the participants will be informed that the study has been halted,” Mitambo said.

He added: “Vaccines are manufactured by different companies; so, at the moment, as researchers, we are still interested to find a vaccine for HIV and I hope pharmaceutical companies will continue inventing vaccines.” Mitambo added that despite that the vaccine is safe, it cannot be given to people because in terms of efficacy, it does not reach the maximum potential in preventing HIV.

Meanwhile, Aids Vaccine Advocacy Coalition (Avac), an international non-profit organisation working to accelerate ethical development and delivery of Aids vaccines and other HIV prevention options, has decried the
failure.

“It is very disappointing that this particular vaccine candidate did not work in this trial but the trial was well-conducted and got an answer quickly. HIV remains a global threat, and a safe, efficacious and accessible HIV vaccine is still needed to contribute towards curbing new infections and providing a durable end to the pandemic,” Avac Executive Director Mitchel Warren said.

Warren has further called for more diversity, creativity and collaboration in deciding what comes next as research
priorities from ongoing vaccine studies “as there are no other vaccine candidates currently on a clear track to licensure”.

“For the last two decades, we have seen HIV prevention trials reporting annual incidence rates of four percent or higher among women trial participants in various East and Southern African countries. Sadly, Johnson & Johnson noted a high rate of HIV infections in this trial as well,” Warren said.

Avac Director of Research Engagement Stacey Hannah has called on donors, research groups and industry to join in strategic discussions with civil society and trial communities in future trials.

“Just as decades of HIV research paved the way for effective Covid-19 vaccines, HIV vaccine developers now need to draw on the creativity, speed, agility and decision making of Covid-19 vaccine development in product development, trial design and regulatory pathways,” Hannah said.

The trial was analysed two years after the women, who were aged 18-35, received their first dose of the investigational vaccine.

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