Last updated: 02/22/2024 17:30:16

Effect of Recombinant Adjuvanted Zoster Vaccine (RZV) on reducing the risk of COVID-19 hospitalization

GSK study ID
217021
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title:
Trial description: RZV was approved in 2017 by Food and Drug Administration (FDA) for the prevention of herpes zoster (HZ) in adults aged ≥50 years. RZV elicits a robust, antigen-specific humoral and cellular immune response in older adults and it could also induce trained innate immunity. Trained innate immune responses after exposure to selected vaccines may trigger non-specific protection against infectious diseases, potentially including COVID-19. The aim of this study is to investigate the potential for RZV to induce trained innate immunity that may translate into some protection against severe COVID-19.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COVID-19 hospitalization in participants who have received at least 1 dose of RZV

Timeframe: During the entire study period (from 01/03/2020 until 31/12/2020)

Secondary outcomes:

COVID-19 hospitalization in participants who have received 2 doses of RZV

Timeframe: During the study period (from 01/03/2020 until 31/12/2020)

COVID-19 diagnosis in participants who have received at least 1 dose of RZV

Timeframe: During the study period (from 01/03/2020 until 31/12/2020)

COVID-19 diagnosis in participants who have received 2 doses of RZV

Timeframe: During the study period (from 01/03/2020 until 31/12/2020)

Odds of a positive SARS-CoV-2 test according to time since most recent RZV vaccination

Timeframe: During the study period (from 01/03/2020 until 31/12/2020)

Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2021-09-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Kaiser Permanente Southern California (KPSC), United States
Study date(s)
May 2021 to July 2021
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Cohort Study:
  • Individuals aged ≥50 years as of 01/03/2020
  • Cohort Study:
  • Individuals with COVID-19 outcomes that occur ≤14 days after receipt of RZV will be excluded. This will only affect individuals who received RZV close to the beginning of the study period (01/03/2020).
Inclusion and exclusion criteria
Inclusion criteria:

    Cohort Study:

    • Individuals aged ≥50 years as of 01/03/2020
    • At least 1 year of continuous KPSC membership prior to 01/03/2020 (allowing for a 31-day gap) Test-Negative Design:
    • Individuals aged ≥50 years as of date of SARS-CoV-2 test
    • At least 1 year of continuous KPSC membership prior to date of SARS-CoV-2 test (allowing for a 31-day gap)
    • Tested for SARS-CoV-2 from 01/03/2020 to 31/12/2020
Exclusion criteria:

    Cohort Study:

    • Individuals with COVID-19 outcomes that occur ≤14 days after receipt of RZV will be excluded. This will only affect individuals who received RZV close to the beginning of the study period (01/03/2020). Test-Negative Design:
    • Individuals who receive a first dose of RZV within 14 days prior to the SARS-CoV-2 test will be excluded, to ensure that individuals were not infected with SARS-CoV-2 prior to vaccination.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol and statistical analysis plan
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2021-09-07
Actual study completion date
2021-09-07

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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