Janssen HIV vaccine: update from APPROACH and largescale efficacy study

Simon Collins, HIV i-Base

As an HIV vaccine is likely to be a critical component of an HIV cure, ongoing results presented by Frank Tomaka and colleagues from Janssen were encouraging for showing improved immune responses to a promising new preventative HIV vaccine. [1]

These were from the phase 2 APPROACH study first presented last year and published in the Lancet in the weeks before AIDS 2018. [2]

This analysis included longer follow-up. All participants generated immune responses that were higher than levels that protected monkeys in animal studies and that were maintained for more than a year and five-year follow-up is planned.

Based on these results a large efficacy study called Imbokodo is already ongoing. Although this new study was referred to several times as phase 3 at the conference, the trial listing is as phase 2. [3, 4]

A second related presentation also suggested that a shorter 24-week vaccine schedule might be just as effective as the 48 week schedule currently used in the Imbokodo study. [5]


  1. Tomaka F et al. Long-term data from APPROACH: Phase 1/2a randomized, double-blind, placebo-controlled study evaluating safety/tolerability and immunogenicity of vaccine regimens using combinations of Ad26.Mos.HIV, MVA-mosaic and gp140 envelope protein. AIDS 2018, 23¬–27 July 2018, Amsterdam. Oral abstract TUAA0104. (abstract and slides)
  2. Barouch DK et al. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). The Lancet 392(10143): 232–243. (06 July 2018)
  3. A study to assess the efficacy of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminum phosphate-adjuvanted clade C gp140 in preventing HIV-1 infection in women in sub-saharan Africa.
  4. Imbokodo website.
  5. Stephenson K et al. HPX1002/IPCAVD010: A randomized controlled trial evaluating the safety and immunogenicity of shorter and simpler vaccine schedules using Ad26.Mos.HIV combined with gp140 Env protein. AIDS 2018, 23¬–27 July 2018, Amsterdam. Oral abstract TUAA0104. (abstract and slides)

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