Herpes ZosterEarly Phase 1NH-ShingrixNCT04523246
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
A Early Phase 1 study testing SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) and Normal Saline in people with Herpes Zoster and Allergy and Immunology, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Allergy and Immunology, Corona Virus Infection
- What is being tested?
- SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) and Normal Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 19 May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Meet Centers for Medicare and Medicaid definition for Long term care resident.
- 65 years and older.
- Have already received or provide consent to receive the 2020 flu vaccine.
- Negative screen (within the last 2 weeks) for COVID 19 virus.
- Has a history of chickenpox or shingles.
- Able to read and speak English.
- Able to provide informed consent and assent (with guardian/health care proxy).
Who cannot join
- Brief Interview of Mental Status (BIMS) score <8 (indicating severe dementia).
- Prior vaccination with the Shingrix.
- Positive test for COVID 19 or prior history of COVID 19 infection.
- Conditions that confound the interpretation of the innate immune measures. (i.e. Terminal condition, receiving hospice, Stage 3 and 4 open wound, Chemotherapy, immune modulators or other immunosuppressants, autoimmune disorders, and BMI < 20 kg/m2).
- Conditions that confound interpretation of respiratory symptoms. (i.e Ventilator dependent, receiving more that 2-3 liters/min of oxygen by nasal cannula, chronic diarrhea, recurrent infections).
Trial locations and contacts
1 site in 1 country.
United States1 site
Fran and Earl Ziegler College of Nursing
Oklahoma City, Oklahoma, 73117
About this study
Official title: Training the Innate Immune System Against SARS-COV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents: A Randomized, Doubled-Blinded, Comparative Group Observational Study
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that:
H1: Shingrix vaccination will elevate acute and trained immunity
H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
Read the detailed description
The purpose of this pilot study is to provide preliminary data in support of the concept that training of the innate immune system occurs following immunization (2 doses ,3 months apart) with the Shingrix vaccine as compared to placebo (normal saline) in older adults residing in nursing homes. Two hundred nursing home residents, both men and women, aged >65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (placebo comparison) approximately three months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (91 days post) and 1 month following the second injection (120 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.
The primary outcome is the difference in immune cell capacity to produce type I interferon, interferon associated molecules, and proinflammatory mediators after receiving a 2 injection series of the Shingrix vaccine versus normal saline. Secondary outcomes include differences in hospitalization, pulmonary infections, and positive COVID-19 cases (via antibody testing on days 90, 120, and 180) in the Shingrix and normal saline groups. We anticipate that residents receiving the Shingrix vaccine will demonstrate signs of "trained" immunity compared to a control group receiving saline injections.
- Being tested
- SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted), Normal Saline
- Keywords
- Herpes Zoster, corona virus infection, allergy and immunology
- Medical subject headings
- Herpes Zoster, Hypersensitivity, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)Biological
Also called Zoster Vaccine Recombinant, Adjuvanted
The Shingrix vaccine is a subunit vaccine that contains the recombinant varicella zoster virus (VZV) glycoprotein E (gE), adjuvanted with the proprietary Adjuvant System (AS01B). The AS01B Adjuvant system consists of two immune-stimulants, the saponin, Quillaja saponaria Molina, fraction 21 (QS21), and the toll-like receptor 4 (TLR4) agonist, MPL (3-O-desacyl-40-MPL) that enhance the release of interferon gamma (IFNϒ), which in turn stimulates activation and recruitment of blood monocyte-derived and resident lymph node dendritic cells to take up and present gE to cluster of differentiation 4 (CD4+) T cells.
Normal SalineDrug
Also called saline
Sterile normal saline, inactive control.
| Study group | Role | What they receive |
|---|---|---|
| Shingrix | Experimental | Shingrix Dosage: two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90). Receives: Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) |
| Normal Saline | Placebo comparator | Sterile Normal Saline Solution, two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90) Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidenced of active and trained innate immunity
The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
Measured: Day 91 and 120 (post vaccination)
Secondary outcomes (1)
Respiratory Disease Severity (6 month)
cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.
Measured: Days 120 through 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2021
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two hundred nursing home residents, both men and women, aged \>65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (comparison) approximately two months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (61 days post) and 1 month following the second injection (90 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation
- Responsible party
- Sponsor
- Investigators
- Barbara W. Carlson, RN, Ph.D., Study director, Professor, University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523246
- Sponsor's protocol ID
- 12394
- Acronym
- NH-Shingrix
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training the Innate Immune System Against SARS-COV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents: A Randomized, Doubled-Blinded, Comparative Group Observational Study
- ClinicalTrials.gov ID
- NCT04523246
- Acronym / sponsor ID
- NH-Shingrix / 12394
- Keywords
- Herpes Zoster, corona virus infection, allergy and immunology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Medical Research Foundation
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that:
H1: Shingrix vaccination will elevate acute and trained immunity
H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
Detailed description
The purpose of this pilot study is to provide preliminary data in support of the concept that training of the innate immune system occurs following immunization (2 doses ,3 months apart) with the Shingrix vaccine as compared to placebo (normal saline) in older adults residing in nursing homes. Two hundred nursing home residents, both men and women, aged >65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (placebo comparison) approximately three months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (91 days post) and 1 month following the second injection (120 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.
The primary outcome is the difference in immune cell capacity to produce type I interferon, interferon associated molecules, and proinflammatory mediators after receiving a 2 injection series of the Shingrix vaccine versus normal saline. Secondary outcomes include differences in hospitalization, pulmonary infections, and positive COVID-19 cases (via antibody testing on days 90, 120, and 180) in the Shingrix and normal saline groups. We anticipate that residents receiving the Shingrix vaccine will demonstrate signs of "trained" immunity compared to a control group receiving saline injections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two hundred nursing home residents, both men and women, aged >65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (comparison) approximately two months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (61 days post) and 1 month following the second injection (90 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.
| Arm | Type | Receives |
|---|---|---|
| Shingrix | Experimental | Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)Shingrix Dosage: two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90). |
| Normal Saline | Placebo comparator | Drug: Normal SalineSterile Normal Saline Solution, two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90) |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Meet Centers for Medicare and Medicaid definition for Long term care resident.
- 65 years and older.
- Have already received or provide consent to receive the 2020 flu vaccine.
- Negative screen (within the last 2 weeks) for COVID 19 virus.
- Has a history of chickenpox or shingles.
Key exclusion criteria (5 listed)
- Brief Interview of Mental Status (BIMS) score <8 (indicating severe dementia).
- Prior vaccination with the Shingrix.
- Positive test for COVID 19 or prior history of COVID 19 infection.
- Conditions that confound the interpretation of the innate immune measures. (i.e. Terminal condition, receiving hospice, Stage 3 and 4 open wound, Chemotherapy, immune modulators or other immunosuppressants, autoimmune disorders, and BMI < 20 kg/m2).
- Conditions that confound interpretation of respiratory symptoms. (i.e Ventilator dependent, receiving more that 2-3 liters/min of oxygen by nasal cannula, chronic diarrhea, recurrent infections).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)Also: Zoster Vaccine Recombinant, AdjuvantedThe Shingrix vaccine is a subunit vaccine that contains the recombinant varicella zoster virus (VZV) glycoprotein E (gE), adjuvanted with the proprietary Adjuvant System (AS01B). The AS01B Adjuvant system consists of two immune-stimulants, the saponin, Quillaja saponaria Molina, fraction 21 (QS21), and the toll-like receptor 4 (TLR4) agonist, MPL (3-O-desacyl-40-MPL) that enhance the release of interferon gamma (IFNϒ), which in turn stimulates activation and recruitment of blood monocyte-derived and resident lymph node dendritic cells to take up and present gE to cluster of differentiation 4 (CD4+) T cells. | Biological | Shingrix |
| Normal SalineAlso: salineSterile normal saline, inactive control. | Drug | Normal Saline |
Primary outcome
Evidenced of active and trained innate immunity
Time frame: Day 91 and 120 (post vaccination)
The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
1 secondary outcome
Respiratory Disease Severity (6 month)
Time frame: Days 120 through 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara W. Carlson, RN, Ph.D. study director
Professor, University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) and Normal Saline in people with Herpes Zoster and Allergy and Immunology, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidenced of active and trained innate immunity (time frame: Day 91 and 120 (post vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.