Inactive

****Amendment 0004 is hereby incorporated to upload additional response to questions, dated 5 may 2021. ****End of Amendment 0004**** ****Amendment 0003 is hereby incorporated to upload additional res... ****Amendment 0004 is hereby incorporated to upload additional response to questions, dated 5 may 2021. ****End of Amendment 0004**** ****Amendment 0003 is hereby incorporated to upload additional responses to questions dated 29 Apr 21. ****End of Amendment 0003**** ****Amendment 0002 is hereby incorporate as follows: Responses to questions are added as an attachment dated 28 Apr 21. ****End of Amendment**** ****Amendment 0001 is hereby incorporated as follows: 1. The date and time for questions and proposal submission are hereby revised as follows: Questions: No later than 12 noon EDT, 3 May 2021 Deadline for Proposals: 12 noon EDT, 12 may 2021. 2. Responses to questions are hereby attached to this announcement. 3. Appendix 2 is hereby revised to include paragraph 2.g. References, and attached as amended. ****End of Amendment 0001**** ***************************************************************************************************************************************************** 1. The purpose of this prototype project is to develop a Plague vaccine for military Emergency Use. Author and conduct an adaptive clinical trial to examine the effect of a biological response modifier (BRM) with adjuvant properties on the immunogenicity of the investigational recombinant F1V (rF1V) plague vaccine in healthy adult subjects compared to immunogenicity outcomes of rF1V vaccine with placebo (NOTE: outcomes from the rF1V vaccine with placebo will also be compared to historical rF1V clinical study data). The goal of this prototype project is to evaluate the safety and technical feasibility for co-administering a BRM with pre-determined schedule doses of the investigational rF1V vaccine to improve the current investigational vaccine’s operational utility for the Military without re-formulation of the current investigational vaccine. These efforts will facilitate development of a potential novel capability to facilitate military rapid-response capabilities afforded by rF1V vaccine as well as other investigational and/or licensed vaccines of interest. Project outcomes may also further future development of next generation rF1V vaccine(s) for the prevention and/or curtailment of pneumonic plague outbreaks. 2. The Government is hereby requesting formal submission of enhanced white papers (“project proposals” or “proposals”) for consideration to execute a formal agreement under 10 USC 2371(b), Other Transaction Authority (OTA) for the prototype project described above: Upon receipt of a proposal submitted in response to this RPP, the next steps are as follows: The Government will evaluate the proposal submissions. Discussions among the parties, whether verbally or in writing, will occur as appropriate. Selection and award(s) will be made after evaluation and selection of a successful proposal(s). (Note: Awards are dependent upon the availability of funds.) 3. This Request for Project Proposal (RPP) is issued to request project proposals in compliance with USC 2371(b), and is being issued for planning purposes only. It is not to be construed as a commitment by the Government to award an agreement, nor will the Government pay for the information solicited. 4. Questions regarding this announcement may be submitted by email to richard.w.totten2.civ@mail.mil by 12 pm Noon, EDT, 20 April 2021.