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All Federal Grant Awards
Project Grant R43AI129378
Award Date
1/17/17
Completion Date
12/30/19
Dollars Obligated
$291K
Overview
Activity
4
Transactions
4
Subawards
Similar Awards
Federal Agency
National Institute of Allergy and Infectious Diseases
Awardee
Biomedical Research Models, Inc. (EKMEBJEJWFN5)
Federal Grant Program
93.855
Assistance Type
Project Grant
Place of Performance
Massachusetts, USA
Update #1
Update #2
SELECTION OF A DEVICE FOR INTRANASAL ADMINISTRATION OF A MUCOSAL VACCINE FOR HSV-2
Posted 1/17/17
5
1
Mod #
Description
ReasonForModification
Federal Obligation
Date
Not listed
SELECTION OF A DEVICE FOR INTRANASAL ADMINISTRATION OF A MUCOSAL VACCINE FOR HSV-2 - GLOBALLY, AN ESTIMATED 16.2% OF THE HUMAN POPULATION IS INFECTED WITH HSV-2 INCLUDING >17% OF THE U.S. ADULT POPULATION. GENITAL HERPES IS ASSOCIATED WITH AN INCREASED RISK OF HIV ACQUISITION AND TRANSMISSION OF HSV-2 INFECTION CAN CAUSE NEONATAL HERPES WITH HIGH INFANT MORTALITY. HSV-2 INFECTION IN THE ADULT POPULATION HAS INCREASED SUBSTANTIALLY IN THE PAST TWO DECADES DESPITE THE AVAILABILITY OF ANTIVIRAL DRUGS. THE FAILURE OF ANTIVIRAL DRUGS TO PREVENT THE SPREAD OF HSV-2 AND THE SHEER MAGNITUDE OF THE PUBLIC HEALTH PROBLEM ASSOCIATED WITH HSV-2 INFECTION INDICATES A NEED FOR A SAFE AND EFFECTIVE VACCINE THAT IS NOT AVAILABLE. AS TO THE PROTECTIVE MECHANISM, THE CURRENT CONSENSUS OF HSV-2 EXPERTS IS THAT SERUM ANTIBODY RESPONSE ALONE IS INSUFFICIENT TO PROVIDE PROTECTIVE IMMUNITY, PRIMARILY BASED ON THE DISAPPOINTING CLINICAL TRIAL RESULTS. THEREFORE, MUCOSAL IMMUNITY AND T CELL RESPONSES ARE CONSIDERED VERY IMPORTANT. HSV-2 IS A VERY UNIQUE VIRUS ABLE TO ESCAPE FROM IMMUNE SURVEILLANCE, AND INHIBIT IMMUNE RESPONSES IN ORDER TO SUCCESSFULLY INFECT THE HOST AND ESTABLISH LATENCY. WITH NIAID-SBIR PHASE I AND II GRANT FUNDING, WE MADE A SIGNIFICANT FINDING THAT HSV-2 INFECTED GUINEA PIGS (GP) UNTREATED OR PROVIDED WITH A REFERENCE VACCINE (THAT MIMICS THE HSV-2 VACCINE WHICH FAILED IN LATEST CLINICAL TRIAL) WERE UNABLE TO ELICIT VAGINAL IGA. UNLIKE OTHER HSV-2 VACCINE CANDIDATES, OUR MUCOSAL VACCINE TECHNOLOGY EMPLOYS A PATENTED HETEROLOGOUS PRIME-BOOST STRATEGY CONSISTING OF A DNA VACCINE PRIME GIVEN INTRAMUSCULARLY (I.M.) AND A PROTEIN-ENCAPSULATED LIPOSOME VACCINE BOOST DELIVERED INTRANASALLY (I.N.). THIS TWO-STEP HETEROLOGOUS IMMUNIZATION STRATEGY DEVELOPED AS A MUCOSAL VACCINE REGIMEN PROVIDES A MULTI-TIERED PROTECTION WITH A TH-1 BIASED, BROAD AND POTENT CELLULAR AND HUMORAL IMMUNE RESPONSE ESPECIALLY MUCOSAL IMMUNE RESPONSE AND VAGINAL PROTECTION AGAINST PRIMARY AND LATENT HSV-2 INFECTION. THIS NOVEL HSV-2 VACCINE SHOWS BOTH PROPHYLACTIC AND THERAPEUTIC EFFICACIES PARTICULARLY AT THE GENITAL SITE OF THE GUINEA PIG MODELS. THE COMPANY WAS RECENTLY FUNDED BY A PHASE IIB SBIR GRANT FOR OUR HSV-2 VACCINE, TO SUPPORT CGMP MANUFACTURING OF KEY VACCINE COMPONENTS TOWARDS THE ULTIMATE GOAL OF IND FILING AND CLINICAL TRIALS. THIS NEW PHASE I R43 SBIR GRANT APPLICATION WAS DEVELOPED IN RESPONSE TO THE STUDY SECTION'S SUGGESTION OF STRENGTHENING STUDIES ON NASAL DELIVERY DEVICES. WE PLAN TO CONDUCT BIO-DISTRIBUTION, BIOAVAILABILITY STUDIES COMPARING NASAL SPRAY VS. NASAL DROP DELIVERED HSV-2 GD-LIPOSOME VACCINE IN NEW ZEALAND WHITE RABBITS. WE ALSO PROPOSE TO COMPARE THE IMMUNOGENICITY AND IMMUNE PROTECTION EFFICACIES OF GD-LIP FORMULATION DELIVERED BY NASAL DROP VS. NASAL SPRAY IN FEMALE GPS THAT WILL BE FIRST PRIMED WITH OUR HSV- 2 DNA VACCINE. IF FUNDED, IT WOULD HELP FILL IN THE GAP IN THE CRITICAL PATHWAY OF ADVANCING OUR MUCOSAL HSV-2 VACCINE CANDIDATE TO CLINICAL TRIALS. THE NET RESULT OF THESE RESEARCH EFFORTS WILL BE TO IDENTIFY A MORE EFFICIENT NASAL DELIVERY DEVICE FOR OUR MUCOSAL HSV-2 VACCINE, AND ULTIMATELY ALLEVIATE PAIN RISK AND SUFFERING IN THE 35- 40 MILLION AMERICANS WITH GENITAL HERPES.
$0
9/26/22
Not listed
SELECTION OF A DEVICE FOR INTRANASAL ADMINISTRATION OF A MUCOSAL VACCINE FOR HSV-2 - GLOBALLY, AN ESTIMATED 16.2% OF THE HUMAN POPULATION IS INFECTED WITH HSV-2 INCLUDING >17% OF THE U.S. ADULT POPULATION. GENITAL HERPES IS ASSOCIATED WITH AN INCREASED RISK OF HIV ACQUISITION AND TRANSMISSION OF HSV-2 INFECTION CAN CAUSE NEONATAL HERPES WITH HIGH INFANT MORTALITY. HSV-2 INFECTION IN THE ADULT POPULATION HAS INCREASED SUBSTANTIALLY IN THE PAST TWO DECADES DESPITE THE AVAILABILITY OF ANTIVIRAL DRUGS. THE FAILURE OF ANTIVIRAL DRUGS TO PREVENT THE SPREAD OF HSV-2 AND THE SHEER MAGNITUDE OF THE PUBLIC HEALTH PROBLEM ASSOCIATED WITH HSV-2 INFECTION INDICATES A NEED FOR A SAFE AND EFFECTIVE VACCINE THAT IS NOT AVAILABLE. AS TO THE PROTECTIVE MECHANISM, THE CURRENT CONSENSUS OF HSV-2 EXPERTS IS THAT SERUM ANTIBODY RESPONSE ALONE IS INSUFFICIENT TO PROVIDE PROTECTIVE IMMUNITY, PRIMARILY BASED ON THE DISAPPOINTING CLINICAL TRIAL RESULTS. THEREFORE, MUCOSAL IMMUNITY AND T CELL RESPONSES ARE CONSIDERED VERY IMPORTANT. HSV-2 IS A VERY UNIQUE VIRUS ABLE TO ESCAPE FROM IMMUNE SURVEILLANCE, AND INHIBIT IMMUNE RESPONSES IN ORDER TO SUCCESSFULLY INFECT THE HOST AND ESTABLISH LATENCY. WITH NIAID-SBIR PHASE I AND II GRANT FUNDING, WE MADE A SIGNIFICANT FINDING THAT HSV-2 INFECTED GUINEA PIGS (GP) UNTREATED OR PROVIDED WITH A REFERENCE VACCINE (THAT MIMICS THE HSV-2 VACCINE WHICH FAILED IN LATEST CLINICAL TRIAL) WERE UNABLE TO ELICIT VAGINAL IGA. UNLIKE OTHER HSV-2 VACCINE CANDIDATES, OUR MUCOSAL VACCINE TECHNOLOGY EMPLOYS A PATENTED HETEROLOGOUS PRIME-BOOST STRATEGY CONSISTING OF A DNA VACCINE PRIME GIVEN INTRAMUSCULARLY (I.M.) AND A PROTEIN-ENCAPSULATED LIPOSOME VACCINE BOOST DELIVERED INTRANASALLY (I.N.). THIS TWO-STEP HETEROLOGOUS IMMUNIZATION STRATEGY DEVELOPED AS A MUCOSAL VACCINE REGIMEN PROVIDES A MULTI-TIERED PROTECTION WITH A TH-1 BIASED, BROAD AND POTENT CELLULAR AND HUMORAL IMMUNE RESPONSE ESPECIALLY MUCOSAL IMMUNE RESPONSE AND VAGINAL PROTECTION AGAINST PRIMARY AND LATENT HSV-2 INFECTION. THIS NOVEL HSV-2 VACCINE SHOWS BOTH PROPHYLACTIC AND THERAPEUTIC EFFICACIES PARTICULARLY AT THE GENITAL SITE OF THE GUINEA PIG MODELS. THE COMPANY WAS RECENTLY FUNDED BY A PHASE IIB SBIR GRANT FOR OUR HSV-2 VACCINE, TO SUPPORT CGMP MANUFACTURING OF KEY VACCINE COMPONENTS TOWARDS THE ULTIMATE GOAL OF IND FILING AND CLINICAL TRIALS. THIS NEW PHASE I R43 SBIR GRANT APPLICATION WAS DEVELOPED IN RESPONSE TO THE STUDY SECTION'S SUGGESTION OF STRENGTHENING STUDIES ON NASAL DELIVERY DEVICES. WE PLAN TO CONDUCT BIO-DISTRIBUTION, BIOAVAILABILITY STUDIES COMPARING NASAL SPRAY VS. NASAL DROP DELIVERED HSV-2 GD-LIPOSOME VACCINE IN NEW ZEALAND WHITE RABBITS. WE ALSO PROPOSE TO COMPARE THE IMMUNOGENICITY AND IMMUNE PROTECTION EFFICACIES OF GD-LIP FORMULATION DELIVERED BY NASAL DROP VS. NASAL SPRAY IN FEMALE GPS THAT WILL BE FIRST PRIMED WITH OUR HSV- 2 DNA VACCINE. IF FUNDED, IT WOULD HELP FILL IN THE GAP IN THE CRITICAL PATHWAY OF ADVANCING OUR MUCOSAL HSV-2 VACCINE CANDIDATE TO CLINICAL TRIALS. THE NET RESULT OF THESE RESEARCH EFFORTS WILL BE TO IDENTIFY A MORE EFFICIENT NASAL DELIVERY DEVICE FOR OUR MUCOSAL HSV-2 VACCINE, AND ULTIMATELY ALLEVIATE PAIN RISK AND SUFFERING IN THE 35- 40 MILLION AMERICANS WITH GENITAL HERPES.
$0
9/26/22
Not listed
SELECTION OF A DEVICE FOR INTRANASAL ADMINISTRATION OF A MUCOSAL VACCINE FOR HSV-2
($9k)
6/2/20
Not listed
SELECTION OF A DEVICE FOR INTRANASAL ADMINISTRATION OF A MUCOSAL VACCINE FOR HSV-2
$300.0k
1/17/17