Last updated: 10/23/2026 14:20:22
Association Between Recombinant Zoster Vaccination and Varicella Zoster Virus Reactivation in United States Astronauts Following Spaceflight
GSK study ID
300273
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Association Between Recombinant ZoSTer Vaccination and Recurrent Subclinical Varicella Zoster Virus Reactivation Among United States AstrOnauts Following Spaceflight (ASTRO-VZV)
Trial description: This retrospective observational study will assess whether recombinant zoster vaccination is associated with reduced subclinical varicella zoster virus reactivation in United States astronauts following spaceflight. Using existing medical records and laboratory data collected before, during, and after space missions, the study will compare varicella zoster virus reactivation in recombinant zoster vaccine-vaccinated and unvaccinated astronauts. The study will also evaluate reactivation of other herpesviruses and selected immune and stress-related biomarkers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Subclinical salivary varicella zoster virus reactivation
Timeframe: Pre-flight, in-flight, immediate post-flight, and recovery periods during space missions conducted between 1999 and 2026
Secondary outcomes:
Subclinical salivary Epstein-Barr virus reactivation
Timeframe: Pre-flight, in-flight, immediate post-flight, and recovery periods during space missions conducted between 1999 and 2026
Subclinical salivary herpes simplex virus type 1 reactivation
Timeframe: Pre-flight, in-flight, immediate post-flight, and recovery periods during space missions conducted between 1999 and 2026
Subclinical urinary cytomegalovirus reactivation
Timeframe: Pre-flight, in-flight, immediate post-flight, and recovery periods during space missions conducted between 1999 and 2026
Changes in stress hormone concentrations
Timeframe: Pre-flight, in-flight, immediate post-flight, and recovery periods during space missions conducted between 1999 and 2026
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2027-07-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Skin Diseases, Infectious
Product
Not applicable
Collaborators
University of Colorado, National Aeronautics and Space Administration (NASA), Aegis Aerospace
Study date(s)
October 2026 to April 2027
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 1) Approved United States astronaut crew members who participated in one or more spaceflight missions between 1999 and 2026.
- 2) Consent provided for analysis of previously collected biological samples.
- Astronaut crew members who completed spaceflight missions before 1999 when laboratory results were not consistently documented.
Inclusion and exclusion criteria
Inclusion criteria:
- 1) Approved United States astronaut crew members who participated in one or more spaceflight missions between 1999 and 2026. 2) Consent provided for analysis of previously collected biological samples. 3) Available medical records and laboratory results. 4) Documented viral load results for varicella zoster virus, Epstein-Barr virus, herpes simplex virus type 1, or cytomegalovirus from saliva or urine samples. 5) Samples collected during at least one pre-flight, in-flight, or post-flight study period. 6) Astronauts may be vaccinated or unvaccinated with recombinant zoster vaccine.
Exclusion criteria:
- Astronaut crew members who completed spaceflight missions before 1999 when laboratory results were not consistently documented.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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