Janssen HIV vaccine: update from APPROACH and largescale efficacy study
24 August 2018. Related: Conference reports, HIV prevention and transmission, Cure-related research, World AIDS 22 Amsterdam 2018.
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]
References
- 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.
http://programme.aids2018.org/Abstract/Abstract/10764 (abstract and slides) - 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)
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31364-3/fulltext - clinicaltrials.gov. 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.
https://clinicaltrials.gov/ct2/show/NCT03060629 - Imbokodo website.
https://www.imbokodo.org.za - 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.
http://programme.aids2018.org/Abstract/Abstract/11441 (abstract and slides)