AFRICA: Johnson & Johnson and global partners have announced the discontinuation of the Imbokodo study of HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa.
The clinical trial of the Imbokodo study ( which is also known as HVTN 705/HPX2008) was in its phase two was was said not to provide sufficient protection against HIV infection.
Announcing the results from the primary analysis of the Phase 2b HIV vaccine clinical trial of the Imbokodo study, Johnson and Johnson stated that the investigational vaccine was found to have a favourable safety profile with no serious adverse events.
The Medical Director, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, Paul Stoffels expressed disappointment that the vaccine candidate did not provide a sufficient level of protection against HIV infection.
“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,
“HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system.
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 of a vaccine to prevent HIV. We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus.”
Johnson and Johnson stated that the HIV vaccine program continues with the global Phase 3 Mosaico HIV study which is evaluating a different composition of the vaccine regimen in different populations.
It also stated that further analysis of the Imbokodo study is ongoing, and the study has provided enough data to progress with key immunological correlates research.
The Imbokodo Study
The Imbokodo vaccine regimen was administered to participants through four vaccination visits over one year.
The primary analysis was conducted 24 months after participants received their first vaccinations.
The study’s primary endpoint was based on the difference in the number of new HIV infections between the placebo and vaccine groups from the 7th month (one month after the third vaccination timepoint) through the 24th month.
Data found out that through 24 months of follow up, 63 of 1,109 participants placebo compared to 51 of 1,079 participants who received active vaccine acquired HIV.
This analysis demonstrated a vaccine efficacy point estimate of 25.2% (95% confidence interval of -10.5% to 49.3%).
It was also discovered that the vaccine regimen did not cause harm and was generally well-tolerated.
The President and Chief Executive Officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol Chair, Professor Glenda Gray said that the knowledge gained from the Imbokodo HIV vaccine trial would be used to continue in the advancement of the pursuit of a global HIV vaccine.
“The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite the great progress made in treatment and prevention, HIV remains a major health challenge for the region.”
About the Phase 2b Imbokodo Study
Imbokodo, a Phase 2b proof-of-concept efficacy study of Janssen’s investigational HIV vaccine regimen, began in 2017, reached full enrollment in 2019 and completed vaccinations on June 30, 2020.
The study enrolled approximately 2,600 young women across five countries in sub-Saharan Africa.
The study took place at 23 trial sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe. Study investigators ensured that any HIV-infected participants in Imbokodo were referred to high-quality HIV treatment and care services.
All Hope is not lost – AVAC
The AIDS Vaccine Advocacy Coalition (AVAC) has said that all hope is not lost with the discontinuation of the Imbokodo HIV vaccine trial adding that the HIV vaccine research must continue despite this disappointing result.
The Executive Director of AVAC, Mitchell Warren expressed disappointment in the trial results stating that the vaccine field needs diversity and creativity and even more collaboration.
“We always hope that efficacy trials will show positive results that lead directly to new prevention options. 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.
“This is in no way the end of the search for an HIV vaccine. We still hope for a positive outcome from the ongoing Mosaico and PrEPVacc studies”
AVAC’s Regional Stakeholder Engagement Manager, Nandisile Luthuli appreciated the contributions of the 2,637 women from five countries in Southern Africa who participated in the trial and commended Johnson & Johnson for their leadership in HIV vaccine research and for their longstanding commitment to Good Participatory Practices (GPP) that must be continued to maintain trust in vaccines and research.
AVAC, through its Director of Research Engagement, Stacey Hannah, calls on donors, research groups and industry to join in strategic discussions with civil society and trial communities to map out a comprehensive strategy for the future of HIV vaccine research, product development and selection, and trial designs.
“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.”
AVAC also calls for HIV prevention researchers, funders and sponsors to learn from the HPTN 084 success and better integrate these options into all future trials.