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Project Title:  Varicella Zoster Virus Shedding After Antiviral Drug (Valacyclovir) Treatment in Antarctic Expeditioners Reduce
Images: icon  Fiscal Year: FY 2021 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/10/2018  
End Date: 10/01/2022  
Task Last Updated: 04/07/2021 
Download report in PDF pdf
Principal Investigator/Affiliation:   Mehta, Satish  Ph.D. / JesTech/KBR/NASA Johnson Space Center 
Address:  Microbiology, 1100 Hercules Ave, 305 
 
Houston , TX 77058-2720 
Email: satish.k.mehta@nasa.gov 
Phone: 281-483-5459  
Congressional District: 36 
Web:  
Organization Type: NASA CENTER 
Organization Name: JesTech/KBR/NASA Johnson Space Center 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Crucian, Brian  Ph.D. NASA Johnson Space Center 
Locke, James  M.D. NASA Johnson Space Center 
Pierson, Duane  Ph.D. NASA Johnson Space Center 
Key Personnel Changes / Previous PI: April 2021 report: none
Project Information: Grant/Contract No. Internal Project 
Responsible Center: NASA JSC 
Grant Monitor: Stenger, Michael  
Center Contact: 281-483-1311 
michael.b.stenger@nasa.gov 
Solicitation / Funding Source: 2017 HERO 80JSC017N0001-Crew Health and Performance (FLAGSHIP1, OMNIBUS). Appendix A-Flagship1, Appendix B-Omnibus 
Grant/Contract No.: Internal Project 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Immune:Risk of Adverse Health Event Due to Altered Immune Response (IRP Rev F)
Human Research Program Gaps: (1) IM-402:Test, optimize and validate pharmacological preventive/mitigative countermeasures (IRP Rev L)
Flight Assignment/Project Notes: NOTE: End date changed to 10/1/2022 per L. Singh/HRP JSC (Ed., 4/8/21)

Task Description: Previous spaceflight studies indicate that reactivation of varicella zoster virus (VZV), particularly during longer duration spaceflights, can potentially lead to clinical disease including zoster, chronic neuropathic pain, vision loss, stroke, and cognitive impairment. Furthermore, continued viral shedding after spaceflight may cause clinical disease in crew contacts including uninfected or immunocompromised individuals, as well as newborn infants. Thus, it is essential to develop spaceflight countermeasures to prevent VZV reactivation and ensure the health of the crew, as well as the health of their contacts upon return. One such countermeasure is prophylactic administration of an antiviral drug (valacyclovir) against VZV. In order to determine the effectiveness of this countermeasure using a large population, we propose to study VZV shedding in Antarctic expeditioners who have similar patterns of VZV DNA shedding in saliva as astronauts. Countermeasure efficacy of the antiviral drug will be determined by measuring VZV reactivation and shedding in saliva as well as measuring the physiological stress biomarkers (cortisol, DHEA, and salivary amylase) and immune markers (inflammatory cytokines) before, during, and after the winter-over period. The proposed research team has extensive experience in ground-based studies including studies conducted in Antarctica, Aquarius undersea habitat, and artificial gravity, as well as the coordination and conduct of complex multi-laboratory studies. In addition, the research team has proven expertise and experience in immunology, virology, and medical expertise working with infectious diseases and spaceflight subjects. This proposal addresses the need for developing and validating countermeasures as identified in the new NASA Research Announcement (NRA) 80JSC017N0001-OMNIBUS NASA HERO Omnibus Opportunity.

Research Impact/Earth Benefits: Our studies have demonstrated that reactivation of VZV, particularly during longer duration spaceflight, can potentially lead to clinical disease including zoster, chronic neuropathic pain, vision loss and cognitive impairment. Furthermore, continued viral shedding post-spaceflight may cause clinical disease in crew contacts including uninfected or immunocompromised individuals, as well as newborn infants. Thus, it is essential to develop spaceflight countermeasures to prevent VZV reactivation and ensure the health of the crew, as well as the health of their contacts upon return. One such countermeasure is prophylactic administration of an antiviral drug (valacyclovir) against VZV. In order to determine the effectiveness of this countermeasure with a relatively large population, we propose to study VZV shedding in Antarctic expeditioners who have had similar patterns of VZV DNA shedding in saliva as astronauts.

These findings will indicate if valacyclovir treatment will reduce or stop viral reactivation and its shedding in saliva. This will enhance the selection and vetting of potential countermeasures to address clinical risks associated with reduced immune function. This will improve crew health care on International Space Station (ISS) missions, and will further enable exploration-class missions.

Task Progress & Bibliography Information FY2021 
Task Progress: Study Overview: The study was conducted at both McMurdo and South Pole Stations during the 2020 winter season. 40 winter-over participants from McMurdo and from South Pole were recruited by the University of Texas Medical Branch (UTMB) point of contact (POC) to take part in the study. This study group was split into a treatment group and a control group. Subjects took the provided drug or placebo daily and collected saliva samples over a period of five consecutive days each month.

Background and Significance: In a recent collaborative study with Dr. Alexander Chouker (European Space Agency-ESA physician researcher), 19 subjects at Concordia Station in Antarctica were examined during overwintering for their latent viral reactivation and shedding patterns in their saliva samples collected each month for before, during, and after winter-over period. VZV DNA was found by real time polymerase assay in 10 out of 19 subjects (52%) with most of the shedding occurring during the study than before or afterwards. This is about the same rate of VZV shedding as we have found in astronauts during short and long duration spaceflights (50-65%). This data provide the motivation for this proposal, i.e., that wintering over in Antarctica is an excellent analog to spaceflight for studying the efficacy of a countermeasure against viral shedding. More specifically, we can study the effect of antiviral agents (e.g., valacyclovir) during an Antarctica winterover and apply lessons learned to upcoming spaceflight missions. This might allow us to prevent viral shedding in astronauts and thus reduce the risk of contaminating the internal environment of the spacecraft with infectious viruses, as well as decreasing their risk of associated VZV diseases including zoster, chronic neuropathic pain, vision loss, stroke and cognitive impairment.

Hypothesis: Prophylactic administration of valacyclovir (1 gram daily) to Antarctic expeditioners will significantly reduce salivary shedding of VZV compared to placebo controls. Measures of stress and immune dysregulation should remain unaltered. To test this hypothesis, we will treat 20 expeditioners with daily valacyclovir and another 20 with placebo and measure VZV DNA (as well as other herpesviruses) before, during, and after the expedition.

Study Population

* General description of the study population: Antarctica expeditioners

* Target number of non-astronaut participants: Total 40: 20 experimental, 20 Placebo

Saliva samples

* About 900 human saliva samples (2 ml each) were collected in total throughout the winter season at McMurdo and 500 samples were collected from South Pole.

* Samples were maintained at -80°C during shipping and received in the Immunology and Virology Lab of Johnson Space Center.

Future plan: A detailed inventory of the samples collected from both McMurdo and South Pole will be done and a plan will be drawn to process these samples as described in the original proposal.

Bibliography Type: Description: (Last Updated: 11/18/2020) 

Show Cumulative Bibliography Listing
 
 None in FY 2021
Project Title:  Varicella Zoster Virus Shedding After Antiviral Drug (Valacyclovir) Treatment in Antarctic Expeditioners Reduce
Images: icon  Fiscal Year: FY 2019 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/10/2018  
End Date: 06/30/2021  
Task Last Updated: 04/11/2019 
Download report in PDF pdf
Principal Investigator/Affiliation:   Mehta, Satish  Ph.D. / JesTech/KBR/NASA Johnson Space Center 
Address:  Microbiology, 1100 Hercules Ave, 305 
 
Houston , TX 77058-2720 
Email: satish.k.mehta@nasa.gov 
Phone: 281-483-5459  
Congressional District: 36 
Web:  
Organization Type: NASA CENTER 
Organization Name: JesTech/KBR/NASA Johnson Space Center 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Crucian, Brian  Ph.D. NASA Johnson Space Center 
Locke, James  M.D. NASA Johnson Space Center 
Pierson, Duane  Ph.D. NASA Johnson Space Center 
Key Personnel Changes / Previous PI: April 2019 report: none
Project Information: Grant/Contract No. Internal Project 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: 2017 HERO 80JSC017N0001-Crew Health and Performance (FLAGSHIP1, OMNIBUS). Appendix A-Flagship1, Appendix B-Omnibus 
Grant/Contract No.: Internal Project 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Immune:Risk of Adverse Health Event Due to Altered Immune Response (IRP Rev F)
Human Research Program Gaps: (1) IM-402:Test, optimize and validate pharmacological preventive/mitigative countermeasures (IRP Rev L)
Task Description: Previous spaceflight studies indicate that reactivation of varicella zoster virus (VZV), particularly during longer duration spaceflights, can potentially lead to clinical disease including zoster, chronic neuropathic pain, vision loss, stroke, and cognitive impairment. Furthermore, continued viral shedding after spaceflight may cause clinical disease in crew contacts including uninfected or immunocompromised individuals, as well as newborn infants. Thus, it is essential to develop spaceflight countermeasures to prevent VZV reactivation and ensure the health of the crew, as well as the health of their contacts upon return. One such countermeasure is prophylactic administration of an antiviral drug (valacyclovir) against VZV. In order to determine the effectiveness of this countermeasure using a large population, we propose to study VZV shedding in Antarctic expeditioners who have similar patterns of VZV DNA shedding in saliva as astronauts. Countermeasure efficacy of the antiviral drug will be determined by measuring VZV reactivation and shedding in saliva as well as measuring the physiological stress biomarkers (cortisol, DHEA, and salivary amylase) and immune markers (inflammatory cytokines) before, during, and after the winter-over period. The proposed research team has extensive experience in ground-based studies including studies conducted in Antarctica, Aquarius undersea habitat, and artificial gravity, as well as the coordination and conduct of complex multi-laboratory studies. In addition, the research team has proven expertise and experience in immunology, virology, and medical expertise working with infectious diseases and spaceflight subjects. This proposal addresses the need for developing and validating countermeasures as identified in the new NASA Research Announcement (NRA) 80JSC017N0001-OMNIBUS NASA HERO Omnibus Opportunity.

Research Impact/Earth Benefits: Our studies have demonstrated that reactivation of VZV, particularly during longer duration spaceflight, can potentially lead to clinical disease including zoster, chronic neuropathic pain, vision loss and cognitive impairment. Furthermore, continued viral shedding post-spaceflight may cause clinical disease in crew contacts including uninfected or immunocompromised individuals, as well as newborn infants. Thus, it is essential to develop spaceflight countermeasures to prevent VZV reactivation and ensure the health of the crew, as well as the health of their contacts upon return. One such countermeasure is prophylactic administration of an antiviral drug (valacyclovir) against VZV. In order to determine the effectiveness of this countermeasure with a relatively large population, we propose to study VZV shedding in Antarctic expeditioners who have had similar patterns of VZV DNA shedding in saliva as astronauts.

These findings will indicate if valacyclovir treatment will reduce or stop viral reactivation and its shedding in saliva. This will enhance the selection and vetting of potential countermeasures to address clinical risks associated with reduced immune function. This will improve crew health care on International Space Station (ISS) missions, and will further enable exploration-class missions.

Task Progress & Bibliography Information FY2019 
Task Progress: Work has been done preparing for approvals from the National Science Foundation (NSF) and the NASA Johnson Space Center Committee for the Protection of Human Subjects (CPHS). The study is being reviewed by NSF for its implementation and we have applied for CPHS approval from JSC.

Bibliography Type: Description: (Last Updated: 11/18/2020) 

Show Cumulative Bibliography Listing
 
 None in FY 2019
Project Title:  Varicella Zoster Virus Shedding After Antiviral Drug (Valacyclovir) Treatment in Antarctic Expeditioners Reduce
Images: icon  Fiscal Year: FY 2018 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/10/2018  
End Date: 06/30/2021  
Task Last Updated: 02/13/2019 
Download report in PDF pdf
Principal Investigator/Affiliation:   Mehta, Satish  Ph.D. / JesTech/KBR/NASA Johnson Space Center 
Address:  Microbiology, 1100 Hercules Ave, 305 
 
Houston , TX 77058-2720 
Email: satish.k.mehta@nasa.gov 
Phone: 281-483-5459  
Congressional District: 36 
Web:  
Organization Type: NASA CENTER 
Organization Name: JesTech/KBR/NASA Johnson Space Center 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Crucian, Brian  Ph.D. NASA Johnson Space Center 
Locke, James  M.D. NASA Johnson Space Center 
Pierson, Duane  Ph.D. NASA Johnson Space Center 
Project Information: Grant/Contract No. Internal Project 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: 2017 HERO 80JSC017N0001-Crew Health and Performance (FLAGSHIP1, OMNIBUS). Appendix A-Flagship1, Appendix B-Omnibus 
Grant/Contract No.: Internal Project 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Immune:Risk of Adverse Health Event Due to Altered Immune Response (IRP Rev F)
Human Research Program Gaps: (1) IM-402:Test, optimize and validate pharmacological preventive/mitigative countermeasures (IRP Rev L)
Task Description: Previous spaceflight studies indicate that reactivation of varicella zoster virus (VZV), particularly during longer duration spaceflights, can potentially lead to clinical disease including zoster, chronic neuropathic pain, vision loss, stroke, and cognitive impairment. Furthermore, continued viral shedding after spaceflight may cause clinical disease in crew contacts including uninfected or immunocompromised individuals, as well as newborn infants. Thus, it is essential to develop spaceflight countermeasures to prevent VZV reactivation and ensure the health of the crew, as well as the health of their contacts upon return. One such countermeasure is prophylactic administration of an antiviral drug (valacyclovir) against VZV. In order to determine the effectiveness of this countermeasure using a large population, we propose to study VZV shedding in Antarctic expeditioners who have similar patterns of VZV DNA shedding in saliva as astronauts. Countermeasure efficacy of the antiviral drug will be determined by measuring VZV reactivation and shedding in saliva as well as measuring the physiological stress biomarkers (cortisol, DHEA, and salivary amylase) and immune markers (inflammatory cytokines) before, during, and after the winter-over period. The proposed research team has extensive experience in ground-based studies including studies conducted in Antarctica, Aquarius undersea habitat, and artificial gravity, as well as the coordination and conduct of complex multi-laboratory studies. In addition, the research team has proven expertise and experience in immunology, virology, and medical expertise working with infectious diseases and spaceflight subjects. This proposal addresses the need for developing and validating countermeasures as identified in the new NASA Research Announcement (NRA) 80JSC017N0001-OMNIBUS NASA HERO Omnibus Opportunity.

Research Impact/Earth Benefits:

Task Progress & Bibliography Information FY2018 
Task Progress: New project for FY2018.

Bibliography Type: Description: (Last Updated: 11/18/2020) 

Show Cumulative Bibliography Listing
 
 None in FY 2018