In Phase 1/2a APPROACH study, HIV-1
antibody response observed in all healthy volunteers
Mosaic-based vaccine regimen is designed
to elicit an immune response against a wide variety of HIV subtypes prevalent
worldwide
Positive clinical and preclinical
results inform selection of lead mosaic HIV vaccine regimen for further
evaluation in Phase 2b proof-of-concept study
PARIS, France--(BUSINESS
WIRE/ME NewsWire)-- Johnson & Johnson today announced encouraging
first-in-human clinical data for an investigational HIV-1 vaccine regimen in
development at its Janssen Pharmaceutical Companies. In an oral
presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS
Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from
Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated
and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).
“Finding a preventive vaccine has
proven to be one of the biggest scientific challenges in the 35-year quest to
end the HIV pandemic. A successful preventive vaccine for HIV will need to
provide broad protection against a wide range of viral strains,” said Professor
Dan Barouch, Harvard Medical School, Director of the Center for Virology and
Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator
for APPROACH. “These promising, early-stage results suggest that these vaccines
utilizing mosaic immunogens should be evaluated further for their potential
ability to achieve this historic goal.”
Significant progress has been made
in the global battle against HIV/AIDS, including the development of critical
antiretroviral treatments and HIV prevention tools, yet the disease remains one
of the greatest global health threats of our time. An estimated 37 million
people are currently living with HIV-1 globally, and nearly 2 million people
become newly infected each year. An effective HIV vaccine is elusive due to the
unique properties of the virus – including its genetic diversity and ability to
mutate rapidly.
Mosaic-based vaccines contain immunogens
created using genes from different HIV subtypes responsible for HIV-1
infections worldwide. These immunogens are delivered through viral vectors,
including Janssen’s AdVac® technology based on adenovirus serotype
26 (Ad26). The viral vectors are combined with other components such as soluble
proteins to form mosaic-based prime-boost vaccine regimens that first prime and
then boost the immune system, with the aim of producing stronger and
longer-lasting immunity to HIV.
Paul Stoffels, M.D., Chief Scientific
Officer, Johnson & Johnson said, “In recent years, a new optimism has
emerged that we will find an effective HIV vaccine in our lifetime. The results
from today’s study add to that belief and we look forward to advancing to the
next stage of clinical development as quickly as possible.”
In pre-clinical studies, regimens
incorporating mosaic vaccines demonstrated protection against infection with an
HIV-like virus. The most effective prime-boost regimen in these studies reduced
the per-exposure risk of infection by 94 percent and resulted in 66 percent
complete protection after six exposures.
Based on immunologic responses
observed in APPROACH, as well as protection observed in pre-clinical studies, a
lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the
Clade C gp140 soluble protein has been selected as the basis for further
evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this
study move forward, Janssen and its global partners anticipate initiating this
investigation in southern African countries in late 2017 or early 2018.
About the APPROACH Study
APPROACH (HIV-V-A004/NCT02315703) is
a multi-center, randomized, parallel-group, placebo-controlled, double-blind
Phase 1/2a study in 393 healthy HIV-uninfected adults in the US, Rwanda,
Uganda, South Africa and Thailand. It is evaluating the safety, tolerability
and immunogenicity of various mosaic-based, prime-boost vaccine regimens for
HIV-1. These vaccine regimens contain two prime doses of the mosaic viral
vector Ad26.Mos.HIV and two boosts of either Ad26.Mos.HIV, MVA-Mosaic and/or
different doses of the soluble protein Clade C gp140 adjuvanted with aluminum
phosphate. Vaccination schedules have been completed for all study participants
and 12-month follow-up after the 4th dose is underway.
Results presented at IAS 2017
suggest that all vaccine regimens appeared to be well-tolerated. Injection site
pain, headache and fatigue were the most common reported adverse events. The
primary analysis post 3rd vaccination showed that most active vaccine regimens
elicited antibody responses in 100% of study participants. Antibody titers
against autologous Clade C and heterologous cross-clade Env antigens increased
in groups boosted with gp140 protein, irrespective of vector. After the 4th
vaccination, humoral and cellular responses further increased.
The APPROACH study was sponsored by
Janssen with support from partner organizations including Beth Israel Deaconess
Medical Center (BIDMC); the United States Military HIV Research Program (MHRP)
at the Walter Reed Army Institute of Research (WRAIR), with the Henry M. Jackson
Foundation for the Advancement of Military Medicine (HJF); the National
Institute of Allergy and Infectious Diseases (NIAID), part of the US National
Institutes of Health (NIH); the Ragon Institute; the International AIDS Vaccine
Initiative (IAVI); and the HIV Vaccine Trials Network (HVTN).
About Janssen’s HIV Preventive
Vaccine
Janssen’s HIV-1 AdVac®-based
vaccine regimen, along with the company’s investigational Ebola and inactivated
polio vaccine candidates, utilize Janssen’s PER.C6® production cell
line technology, which has the potential to reduce costs by increasing vaccine
production at lower reactor volume.
Since 2005, Janssen Vaccines &
Prevention B.V. has been participating in the NIH-supported Integrated
Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants
AI066305, AI078526 and AI096040. Janssen’s HIV vaccine program has also
received funding from the United States Military HIV Research Program and the
Ragon Institute.
Please visit www.jnj.com/HIV
for further details on the breadth of HIV science being presented by Johnson
& Johnson companies and its partners.
About Johnson & Johnson
Caring for the world one person at a
time inspires and unites the people of Johnson & Johnson. We embrace
research and science – bringing innovative ideas, products and services to advance
the health and well-being of people. Our approximately 126,400 employees at
more than 230 Johnson & Johnson operating companies work with partners in
health care to touch the lives of over a billion people every day, throughout
the world.
About the Janssen Pharmaceutical
Companies
At the Janssen Pharmaceutical
Companies of Johnson & Johnson, we are working to create a world without
disease. Transforming lives by finding new and better ways to prevent,
intercept, treat and cure disease inspires us. We bring together the best minds
and pursue the most promising science. We are Janssen. We collaborate with the
world for the health of everyone in it. Learn more at www.janssen.com.
Follow us at @JanssenGlobal.
Cautions Concerning Forward-Looking
Statements
This press release contains
"forward-looking statements" as defined in the Private Securities
Litigation Reform Act of 1995, regarding development of a potential preventive
vaccine for HIV. 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. 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 1, 2017, including under “Item 1A. Risk Factors,” its most
recently filed Quarterly Report on Form 10-Q, including under the caption
“Cautionary Note Regarding Forward-Looking Statements,” 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 or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or developments.