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Early phase 1 HIV vaccine study launched in the US and South Africa

1 October 2023. Related: Vaccines and microbicides.

NIAID press release

Red speckled matter spanning from the top left corner to the middle of the image, bounded by a thick red undulating line from which blue spheres are shown in different stages of separating from that line. One blue sphere is completely separated from the red line.

Electron micrograph of HIV particles. Credit: NIAID

On 20 September 2023, NIAID issued a press release about an early study of a potential HIV vaccine called VIR-1388. [1]

The study aims to enrol 95 people from sites in the US and South Africa with early results by the end of 2024 and an additional three years follow-up. [2]

The study will look for immune responses to the vaccine rather than whether it stops infection. It will also check for safety.

The vaccine uses a cytomegalovirus (CMV) vector, meaning a weakened version of CMV delivers the HIV vaccine to the immune system without the risk of causing disease in participants. NIAID has funded the discovery and development of the CMV vaccine vector since 2004.

This trial is sponsored by Vir and conducted through the NIAID-funded HIV Vaccine Trials Network as study HVTN 142.

HVTN 142 is taking place at six sites in the United States and four in South Africa and will enrol 95 HIV-negative participants. Participants will be randomised to one of four study arms. Three arms will each receive a different dose of the vaccine, and one will receive a placebo.

To reduce any risk from CMV, participants need to be already living CMV, without symptoms.

Further information is online. [2]

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It is notable that former NIAID-head Anthony Fauci recently commented in an interview with Jon Cohen in Science, that compared to an annual ARV which ‘we will have shortly’, a CMV-based vaccine with low efficacy ‘would not stand a chance’. [3]

References

  1. NIAID press statement. Clinical study of HIV vaccine begins in United States and South Africa. (20 September 2023).
    https://www.niaid.nih.gov/news-events/clinical-trial-hiv-vaccine-begins-united-states-and-south-africa
  2. ClinicalTrials.gov. To investigate safety, reactogenicity and immunogenicity of VIR-1388 compared with placebo in participants without HIV.
    https://www.clinicaltrials.gov/study/NCT05854381
  3. Anthony Fauci on becoming the ‘devil’ and a warning for his successor. Science, (25 September 2023).
    https://www.science.org/content/article/anthony-fauci-becoming-devil-and-warning-his-successor

This report was first posted on 20 September 2023.

Links to other websites are current at date of posting but not maintained.