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IAVI, Moderna Launch First-in-Africa Clinical Trial of mRNA HIV Vaccine

The first study to test this new technology that started with COVID-19 vaccines will have sites in Rwanda and South Africa which are building on recent findings from a similar trial conducted among healthy adults in the US where researchers found vaccination induced the targeted immune responses in 97% of recipients.

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Moderna and global scientific research organization IAVI announced on Wednesday that they are set to start screening participants into a Phase I Clinical trial in which they are testing effectiveness of an mRNA vaccine in preventing HIV.

The first study to test this new technology that started with COVID-19 vaccines will have sites in Rwanda and South Africa which are building on recent findings from a similar trial conducted among healthy adults in the US where researchers found vaccination induced the targeted immune responses in 97 per cent of recipients.

The new study dubbed IAVI G003 will involve 18 healthy, HIV-negative adult volunteers who will receive two doses of the vaccine, which contains a portion of the viral sequence and cannot cause an infection with HIV.

According to a statement released on Wednesday, there is no blinding and no randomization in this open-label study and that all participants will receive the intervention.

“IAVI G003 is designed to test the hypothesis that vaccination... developed by scientific teams at IAVI and delivered via Moderna’s mRNA platform can induce similar immune responses in African populations as was seen for IAVI G001 in the US”, reads the statement in part. 

In his remarks, IAVI CEO Mark Feinberg said while the road to an HIV vaccine has been long and winding with the search starting more than 30 years ago, mRNA technology has the potential to accelerate the development of a safe, effective, affordable, and durable HIV vaccine for use throughout the world.

Commenting about this announcement that collides with the World HIV Vaccine Awareness day marked every 18th of May, Linda – Gail Bekker, an HIV activist and Professor of Medicine said this renews their hope for a vaccine after a hitherto promising Phase 2b trial   known as Imbokodo was discontinued last year when people in the study got infected.

She said the pipeline is rich with five mRNA vaccine candidates now being tested across the world. In addition to these, there’s a PrEPVACC ongoing in East and Southern Africa testing an experimental vaccine and Pre-Exposure Prophylaxis at the same time. 

//Cue in; “We have lost…     

Cue out...mRNA as a vector.”//  

On her part, Maureen Luba, a Programs Officer at the Global Advocacy for HIV Prevention (AVAC) said even with other HIV prevention innovations recently found, the vaccine remains an important public health intervention and this new technology marks a new research age.

//Cue in; “Our only way...     

Cue out... key important lessons.”//

Meanwhile, Enrolled participants in the new study will be monitored for safety for six months after receipt of the last dose, and their immune responses will be examined in molecular detail to evaluate whether the targeted responses will be achieved.

The primary trial endpoints are safety and immunogenicity, defined as the ability of a substance to elicit an immune response.  

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