NEW BRUNSWICK, N.J.,
Aug. 31, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ), together with a
consortium of global partners, today announced results from the
primary analysis of a Phase 2b HIV
vaccine clinical trial known as the Imbokodo study (also known as
HVTN 705/HPX2008). Data showed the
investigational HIV vaccine regimen did not provide sufficient
protection against HIV infection in a population of young women in
sub-Saharan Africa at high risk of acquiring HIV. The
investigational vaccine was found to have a favorable safety
profile with no serious adverse events.
Based on these results, the Imbokodo study will not continue.
Study participants will be notified of the results, unblinded and
informed whether they were in the study group who received the
vaccine or the group who received placebo. Further analysis of the
Imbokodo study is ongoing, and the study has provided enough data
to progress with key immunological correlates research.
In parallel to the Phase 2b
Imbokodo HIV vaccine trial, Janssen is sponsoring the ongoing Phase
3 Mosaico study (HVTN 706/HPX3002) which is testing the safety and
efficacy of a different composition of the HIV vaccine regimen
among men who have sex with men (MSM) and transgender individuals.
This study is being conducted in the Americas and Europe where different strains of HIV are
circulating. Given these differentiating factors and following
consultations with the Mosaico study independent Data and Safety
Monitoring Board (DSMB), it was decided that the Mosaico study will
continue at this time.
"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," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer at Johnson & Johnson. "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 for 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."
What the Imbokodo Data Tell Us
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 number of new HIV
infections between the placebo and vaccine groups from month seven
(one month after the third vaccination timepoint) through month 24.
These data found that through 24 months of follow up, 63 of 1,109
participants who received 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%). The vaccine regimen
did not cause harm and was generally well-tolerated.
"The high incidence of HIV among young women in sub-Saharan
Africa reminds us that, despite great progress made in treatment
and prevention, HIV remains a major health challenge for the
region," said Professor Glenda Gray,
President and Chief Executive Officer, South African Medical
Research Council (SAMRC) and Imbokodo's Protocol Chair. "This
underscores the need to apply the knowledge that will be gained
from this trial to continue to advance the pursuit of a global HIV
vaccine."
The Imbokodo study tested an investigational HIV regimen with an
adenovirus vector containing four mosaic immunogens (Ad26.Mos4.HIV)
at four vaccination visits over one year. The Imbokodo regimen
contains a soluble protein component (Clade C gp140, adjuvanted
with aluminum phosphate) which is administered at vaccination
visits three and four. The ongoing Phase 3 Mosaico study is testing
a different investigational vaccine regimen that involves the
administration of a mosaic-based mixture of soluble proteins (Clade
C/Mosaic gp140) at vaccination visits three and four.
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, a region where women
and girls accounted for 63 percent of all new HIV infections in
2020.1 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.
Imbokodo was supported by a public-private partnership led by
Janssen Vaccines & Prevention B.V., part of the Janssen
Pharmaceutical Companies of Johnson & Johnson; the National
Institute of Allergy and Infectious Diseases, part of the National
Institutes of Health; the Bill & Melinda Gates Foundation; and
the HIV Vaccine Trials Network (HVTN). Additional partners
providing support included the U.S. Army Medical Research and
Development Command (USAMRDC) and the Ragon Institute of MGH,
MIT and Harvard. The study was conducted at clinical sites
coordinated by HVTN, and the South African Medical Research Council
(SAMRC) helped to implement Imbokodo in South Africa.
Since 2005, Janssen Vaccines & Prevention B.V. has been
participating as a sub-grantee in the NIH-supported Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program
under grants AI066305, AI078526, AI096040 and AI128751 (Principal
Investigator, Prof. Dan
Barouch).
Johnson & Johnson's Commitment to HIV
Johnson
& Johnson has been committed to the fight against HIV for 25
years, playing a central role in bringing nine therapeutics to
people living with HIV, and continues to drive innovation in HIV
prevention and care.
In December 2020, the European
Commission authorized the first complete, long-acting injectable
treatment for HIV, which combines Janssen's rilpivirine with ViiV
Healthcare's cabotegravir, offering people with HIV living in
Europe the potential of replacing
daily oral treatments with six injections per year
(every-other-month). In January 2021,
the U.S. Food and Drug Administration approved the treatment for an
every-month dosing schedule (12 injections per year), and is
considering a supplement New Drug Application (sNDA) that would
extend this approval to include the every-other-month dosing
schedule (6 injections per year). Also in January, the dapivirine
ring, a discreet long-acting HIV prevention method specifically for
women developed by the International Partnership for Microbicides
(IPM) and based on Janssen's compound, was recommended by the World
Health Organization as an additional prevention choice for women
with a substantial chance of contracting HIV as part of combination
prevention approaches.
Johnson & Johnson also supports communities affected by HIV
through initiatives such as the DREAMS Partnership in sub-Saharan
Africa, the MenStar Coalition and the New Horizons program. To
learn more, visit jnj.com/hiv.
About Johnson & Johnson
At Johnson & Johnson,
we believe good health is the foundation of vibrant lives, thriving
communities and forward progress. That's why for more than 130
years, we have aimed to keep people well at every age and every
stage of life. Today, as the world's largest and most broadly-based
healthcare company, we are committed to using our reach and size
for good. We strive to improve access and affordability, create
healthier communities, and put a healthy mind, body and environment
within reach of everyone, everywhere. We are blending our heart,
science and ingenuity to profoundly change the trajectory of health
for humanity. Learn more at http://www.jnj.com/. Follow us
at @jnjglobalhealth.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease
is a thing of the past. We're the Pharmaceutical Companies of
Johnson & Johnson, working tirelessly to make that future a
reality for patients everywhere by fighting sickness with science,
improving access with ingenuity, and healing hopelessness with
heart. We focus on areas of medicine where we can make the biggest
difference: Cardiovascular & Metabolism, Immunology, Infectious
Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension. Learn more at www.janssen.com. Follow us
at www.twitter.com/JanssenGlobal.
*Dr. Glenda Gray, President and
Chief Executive Officer, South African Medical Research Council
(SAMRC), is Protocol Chair of the Imbokodo study. Janssen
Vaccines & Prevention B.V.
partnered with the South African Medical Research Council (SAMRC)
to help implement Imbokodo in South
Africa.
Cautions Concerning Forward-Looking Statements
This
press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding
Janssen's investigational, mosaic-based HIV vaccine regimen. The
reader is cautioned not to rely on these forward-looking
statements. These statements are based on current expectations of
future events. If underlying assumptions prove inaccurate or known
or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen
Vaccines & Prevention B.V , any of the other Janssen
Pharmaceutical Companies and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
January 3, 2021, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of the
Janssen Pharmaceutical Companies nor Johnson & Johnson
undertakes to update any forward-looking statement as a result of
new information or future events or developments.
1UNAIDS. GLOBAL HIV STATISTICS – Fact Sheet 2021.
June 2021.
https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf.
Last accessed July 2021.
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