Solicitation Number: BAA-NIH-BARDA-NIAID-DMID-AI2007003
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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BAA-NIH-BARDA-NIAID-DMID-AI2007003
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Award
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September 30, 2008
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HHSN272200800056C
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Base $29,819,598, All Options $40,525,713
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Crucell Holland BV
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Archimedesweg 4-6
2333 CN Leiden, Netherlands
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Added: September 4, 2007
The National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH), of the Department of Health and
Human Services (DHHS) supports research related to the basic
understanding of microbiology and immunology leading to the development
of vaccines, therapeutics, and medical diagnostics for the prevention,
treatment, and diagnosis of infectious and immune-mediated diseases.
This project will be funded in whole or in part with Federal funds from
the Biomedical Advanced Research and Development Authority (BARDA),
DHHS, in conjunction with the NIAID, NIH. The NIAID, Division of
Microbiology and Infectious Diseases (DMID) has a requirement for the
development of a prophylactic multivalent filovirus vaccine that is
capable of protecting against both Ebola and Marburg viruses, utilizing
platform technology such that the same basic development and
manufacturing process is used to develop each component of the final
multivalent vaccine. NOTE 1: This solicitation will NOT support the
development of devices for the delivery of vaccines; the development of
therapeutic agents and therapeutic vaccines; the development of new
animal models or refinement of existing animal models; the design and
conduct of Phase 3 clinical trials; nor the development of any adjuvants
which are not currently used in FDA-licensed vaccines. NOTE 2: BSL-4
facilities for animal model development, animal model vaccine efficacy
testing, and assay development are to be proposed by the offeror(s).
However, the Government retains the right to negotiate the most
effective and efficient mechanisms for providing such facilities. This
solicitation seeks to fund organizations with demonstrated vaccine
product development experience to advance development of a prophylactic
candidate multivalent filovirus vaccine that protects against both Ebola
and Marburg viruses. For the purposes of this solicitation, candidate
vaccines need not have been tested in a multivalent manner nor have
shown protection against all desired strains of Ebola and Marburg.
Candidate vaccines eligible for support must have two characteristics:
First, a candidate vaccine must utilize a platform technology such that
the same basic development and manufacturing process can be used to
develop each component of the final multivalent vaccine; and Second, the
proposed platform technology must have been used successfully to
demonstrate the efficacy of the vaccine candidate in non-human primate
(NHP) Ebola and Marburg challenge models. It is sufficient for the
platform technology to have demonstrated protection in a monovalent
vaccination/challenge study design, that is, a monovalent Marburg
vaccine tested in the Marburg NHP challenge model and a monovalent Ebola
vaccine tested in the Ebola NHP challenge model. The target
multivalent vaccine must contain/express antigens of SEBOV, ZEBOV,
ICEBOV, RAVN, and either Ci67, Musoke, or another closely related strain
of Marburg, and must provide for a relatively rapid onset of protection
following no more than two doses, post-exposure prophylaxis will also
be considered. Protection is defined as proof of concept efficacy
(greater than 80% survival) in the NHP challenge model (i.m. route of
infection with greater than or equal to 100 pfu of challenge virus).
Offerors must propose a well-defined and feasible Product Development
Plan for advancing the vaccine candidate by carrying out the following
research and development activities as specified in the negotiated
Statement of Work: 1) development and update of the Product Development
Plan for a multivalent filovirus vaccine candidate, including
regulatory, clinical, non-clinical, and manufacturing activities to be
undertaken; 2) manufacturing and formulation process development; 3)
manufacturing of pilot lot cGMP material; 4) real time and accelerated
vaccine stability studies; 5) conduct of non-clinical studies, including
all Investigational New Drug (IND)-enabling toxicology studies and
multivalent immunogenicity interference studies; 6) development,
qualification and, where necessary, validation of all assays and
reagents necessary to support product development; 7) development,
submission, and sponsorship of an Investigational New Drug (IND)
application, including compliance with all regulatory requirements; 8)
design, conduct, completion, and analysis of a Phase 1 dose-escalating
clinical trial of the multivalent vaccine candidate in healthy subjects
ages 18 to 40; 9) the provision of clinical and non-clinical samples
from all studies to NIAID and, for clinical trials, obtaining future use
consent from volunteers for their samples; and 10) the provision to
NIAID of cGMP final container vaccine and all necessary supporting
documentation/letters of cross-reference to allow NIAID to perform
subsequent clinical trials. OPTIONS: Contracts awarded under this
Broad Agency Announcement will include three Options that may be
exercised at the discretion of the Government. Options 1 and 2 may be
undertaken concurrently. However, Option 3 may not be undertaken until
successful completion of the tasks described in Option 1 as determined
by the Government. Option 1 provides for performance of all activities
associated with the transfer and scale-up from pilot scale to
large-scale cGMP manufacturing and release of 200,000 doses minimum
target scale of the candidate vaccine for use in further clinical
trials. Option 2 provides for the conduct of studies to develop a
lyophilized final container formulation to improve vaccine shelf-life
and stability. Option 3 provides for the design, conduct, completion,
and analysis of a Phase 2 clinical trial to evaluate further the safety
and immunogenicity of the candidate multivalent vaccine. It is
anticipated that multiple cost-reimbursement, completion type contracts
will be awarded. Funding will be consistent with the nature and
complexity of the proposed research. It is anticipated that the period
of performance for the BASE period will be five years beginning on or
about September 20, 2008, with Options to be exercised at the
Government?s discretion for a maximum period of performance of 9 years.
It is anticipated that each OPTION will cover a period of two years.
Options 1 and 2 may be undertaken concurrently. However, Option 3 may
not be undertaken until successful completion of Option 1, as determined
by the Government. It is estimated that the provision of total FTEs
will be as follows: Base Period: 13.85 total FTEs for a 5-year period;
Option 1: 3.75 total FTEs for a 2-year period; Option 2: 4.65 total
FTEs for a 2-year period; and Option 3: 9.1 total FTEs for a 2-year
period. Any responsible offeror may submit a proposal which will be
considered by the Agency. This Broad Agency Announcement will be
available electronically on/about September 18, 2007, and may be
accessed through FedBizOpps http://www.fedbizopps.gov/. This notice
does not commit the Government to award a contract. No collect calls
will be accepted. No facsimile transmissions will be accepted. See
Government-Wide Numbered Note 26.
Added: Sep 30, 2008 4:19 pm
Additional contract awarded from this BAA (see separate award notice): HHSN272200800056C - Crucell Holland BV.
Added: Sep 30, 2008 4:27 pm
Additional contract awarded from this BAA (see separate award notice): HHSN272200800055C - Integrated BioTherapeutics, Inc.
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