Delving into the Latest Updates on pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) with Synapse

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

Start Date09 Jul 2014

Sponsor / Collaborator

U S Army Medical Research & Development Command

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NCT01502345 / CompletedPhase 1IIT

Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines, pWRG/HTN-M(x) and pWRG/PUU-M(s2), for Prevention of Hemorrhagic Fever With Renal Syndrome Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device

The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.

Start Date01 Jan 2012

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+4]

100 Clinical Results associated with pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)

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100 Translational Medicine associated with pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)

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100 Patents (Medical) associated with pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)

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13

Literatures (Medical) associated with pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)

01 Jun 2016·VaccineQ3 · MEDICINE

A Phase 1 clinical trial of a DNA vaccine for Venezuelan equine encephalitis delivered by intramuscular or intradermal electroporation

Q3 · MEDICINE

Article

Author: Ellefsen, Barry ; Hannaman, Drew ; Dupuy, Lesley C ; Schmaljohn, Connie S

Venezuelan equine encephalitis virus (VEEV), a mosquito-borne alphavirus, causes periodic epizootics in equines and is a recognized biological defense threat for humans. There are currently no FDA-licensed vaccines against VEEV. We developed a candidate DNA vaccine expressing the E3-E2-6K-E1 genes of VEEV (pWRG/VEE) and performed a Phase 1 clinical study to assess the vaccine's safety, reactogenicity, tolerability, and immunogenicity when administered by intramuscular (IM) or intradermal (ID) electroporation (EP) using the Ichor Medical Systems TriGrid™ Delivery System. Subjects in IM-EP groups received 0.5mg (N=8) or 2.0mg (N=9) of pWRG/VEE or a saline placebo (N=4) in a 1.0ml injection. Subjects in ID-EP groups received 0.08mg (N=8) or 0.3mg (N=8) of DNA or a saline placebo (N=4) in a 0.15ml injection. Subjects were monitored for a total period of 360 days. No vaccine- or device-related serious adverse events were reported. Based on the results of a subject questionnaire, the IM- and ID-EP procedures were both considered to be generally acceptable for prophylactic vaccine administration, with the acute tolerability of ID EP delivery judged to be greater than that of IM-EP delivery. All subjects (100%) in the high and low dose IM-EP groups developed detectable VEEV-neutralizing antibodies after two or three administrations of pWRG/VEE, respectively. VEEV-neutralizing antibody responses were detected in seven of eight subjects (87.5%) in the high dose and five of eight subjects (62.5%) in the low dose ID-EP groups after three vaccine administrations. There was a correlation between the DNA dose and the magnitude of the resulting VEEV-neutralizing antibody responses for both IM and ID EP delivery. These results indicate that pWRG/VEE delivered by either IM- or ID-EP is safe, tolerable, and immunogenic in humans at the evaluated dose levels. Clinicaltrials.gov registry number NCT01984983.

04 Mar 2015·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin

Q3 · MEDICINE

Article

Author: Kate E Broderick ; Jay R McCoy ; Alan F Gomez ; Niranjan Y Sardesai ; Catherine Badger ; Kristin W Spik ; Connie S Schmaljohn ; Janess M Mendoza

The identification of an effective and tolerable delivery method is a necessity for the success of DNA vaccines in the clinic. This article describes the development and validation of a multi-headed intradermal electroporation device which would be applicable for delivering multiple DNA vaccine plasmids simultaneously but spatially separated. Reporter gene plasmids expressing green and red fluorescent proteins were used to demonstrate the impact of spatial separation on DNA delivery to increase the number of transfected cells and avoid interference through visible expression patterns. To investigate the impact of plasmid interference on immunogenicity, a disease target was investigated where issues with multi-valent vaccines had been previously described. DNA-based Hantaan and Puumala virus vaccines were delivered separately or as a combination and the effect of multi-valence was determined by appropriate assays. While a negative impact was observed for both antigenic vaccines when delivered together, these effects were mitigated when the vaccine was delivered using the multi-head device. We also demonstrate how the multi-head device facilitates higher dose delivery to the skin resulting in improved immune responses. This new multi-head platform device is an efficient, tolerable and non-invasive method to deliver multiple plasmid DNA constructs simultaneously allowing the tailoring of delivery sites for combination vaccines. Additionally, this device would allow the delivery of multi-plasmid vaccine formulations without risk of impacted immune responses through interference. Such a low-cost, easy to use device platform for the delivery of multi-agent DNA vaccines would have direct applications by the military and healthcare sectors for mass vaccination purposes.

03 Oct 2014·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A multi-head intradermal electroporation device allows for tailored and increased dose DNA vaccine delivery to the skin

Q3 · MEDICINE

Article

Author: Mendoza, Janess M ; McCoy, Jay R ; Schmaljohn, Connie S ; Spik, Kristin W ; Broderick, Kate E ; Sardesai, Niranjan Y ; Gomez, Alan F ; Badger, Catherine

The identification of an effective and tolerable delivery method is a necessity for the success of DNA vaccines in the clinic. This manuscript describes the development and validation of a multi-headed intradermal electroporation device which would be applicable for delivering multiple DNA vaccine plasmids simultaneously but spatially separated. Reporter gene plasmids expressing green and red fluorescent proteins were used to demonstrate the impact of spatial separation on DNA delivery to increase the number of transfected cells and avoid interference through visible expression patterns. To investigate the impact of plasmid interference on immunogenicity, a disease target was investigated where issues with multi-valent vaccines had been previously described. DNA-based Hantaan and Puumala virus vaccines were delivered separately or as a combination and the effect of multi-valence was determined by appropriate assays. While a negative impact was observed for both antigenic vaccines when delivered together, these effects were mitigated when the vaccine was delivered using the multi-head device. We also demonstrate how the multi-head device facilitates higher dose delivery to the skin resulting in improved immune responses. This new multi-head platform device is an efficient, tolerable and non-invasive method to deliver multiple plasmid DNA constructs simultaneously allowing the tailoring of delivery sites for combination vaccines. Additionally, this device would allow the delivery of multi-plasmid vaccine formulations without risk of impacted immune responses through interference. Such a low-cost, easy to use device platform for the delivery of multi-agent DNA vaccines would have direct applications by the military and healthcare sectors for mass vaccination purposes.

100 Deals associated with pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhagic Fevers, Viral	Phase 2	-	Ichor Medical Systems, Inc.	-
Hemorrhagic Fevers, Viral	Phase 2	-	United States Army Medical Research and Materiel Command	-
Hemorrhagic Fever With Renal Syndrome	Preclinical	US	Ichor Medical Systems, Inc.	01 Jan 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02116205 (CTgov)	Phase 2	Hemorrhagic Fever With Renal Syndrome	130	Placebo+HTNV/PUUV DNA vaccine (Vaccine + Placebo at 1.0 mg)	gntrpgblqd(uderzqglej) = whehrzgrnu gcttgzldtg (ujgvaykpqs, xfitgsuijq - njpxpvwydf) View more	-	01 Dec 2020
				TriGrid Delivery System (TDS)+HTNV/PUUV DNA vaccine (Vaccine at 1.0 mg)	gntrpgblqd(uderzqglej) = kjnhkqfllt gcttgzldtg (ujgvaykpqs, svckrftfyg - blgzpyzlxu) View more