Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT05580458
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2022-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)
Status:
RECRUITING
Status Verified Date:
2025-12-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18. Researchers want to learn more about how people with HIV respond to Shingrix.
Objective:
To learn how Shingrix affects the immune response in people with HIV.
Eligibility:
People aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed.
Design:
Participants will have at least 4 clinic visits in 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests.
At their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria.
Participants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot.
Participants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot.
Participants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm.
Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18. Researchers want to learn more about how people with HIV respond to Shingrix.
Objective:
To learn how Shingrix affects the immune response in people with HIV.
Eligibility:
People aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed.
Design:
Participants will have at least 4 clinic visits in 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests.
At their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria.
Participants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot.
Participants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot.
Participants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm.
Detailed Description:
Study Description:
This phase 1/2 open-label study will evaluate the safety and immunogenicity of the Shingrix recombinant varicella zoster virus vaccine (RZV) in people with HIV (PWH) aged 18 years and older and healthy volunteers aged 50 years and older. Shingrix will be administered by intramuscular (IM) injection during visits at months 0 and 2, and blood will be collected prior to each dose and at follow-up visits at months 3 and 12. Study evaluations will include assessment of adverse events (AEs) by physical examination, safety laboratory evaluations, and participant memory tool, and assessment of response in research immunogenicity assays on blood.
Objectives:
Primary Objective:
-Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.
Secondary Objectives:
* Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH by age (\< 50 and \>= 50 years).
* Compare vaccine immunogenicity in PWH versus healthy volunteers.
* Evaluate grade 3 and 4 safety responses in PWH, based upon CD4 count (\< 300 and \>= 300), and healthy volunteers.
* Evaluate grade 3 and 4 safety responses in PWH, based upon age (\< 50 and \>= 50), and healthy volunteers.
Tertiary/Exploratory Objectives:
* Compare immune cell responses in PWH, based upon CD4 count (\< 300 and \>= 300), and healthy volunteers.
* Compare immune cell responses in PWH, based upon age (\< 50 and \>= 50 years), and healthy volunteers.
* Assess vaccine immunogenicity by varicella zoster serostatus.
* Assess zoster reactivation.
* Correlate the microbiome profile with vaccine responses.
Endpoints:
Primary Endpoint:
-Fold change of anti-glycoprotein gE (anti-gE) antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (\< 300 and \>= 300) run by GlaxoSmithKline (GSK).
Secondary Endpoints:
* Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by age (\< 50 and \>= 50) run by GSK.
* Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) in PWH and healthy volunteers run by GSK.
* Grade 3 and/or Grade 4 Shingrix AEs (solicited and unsolicited local and systemic).
Tertiary/Exploratory Endpoints:
* T-cell assays and phenotypes evaluated regularly through end of study.
* Varicella zoster serostatus as determined by IgG and IgM antibody levels.
* Number of episodes and severity of zoster reactivation (including extradermatomal complications such as neurologic or ophthalmologic complications and adverse sequelae such as post herpetic neuralgia).
* Baseline microbiome profile.
This phase 1/2 open-label study will evaluate the safety and immunogenicity of the Shingrix recombinant varicella zoster virus vaccine (RZV) in people with HIV (PWH) aged 18 years and older and healthy volunteers aged 50 years and older. Shingrix will be administered by intramuscular (IM) injection during visits at months 0 and 2, and blood will be collected prior to each dose and at follow-up visits at months 3 and 12. Study evaluations will include assessment of adverse events (AEs) by physical examination, safety laboratory evaluations, and participant memory tool, and assessment of response in research immunogenicity assays on blood.
Objectives:
Primary Objective:
-Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH based upon CD4 count \< 300 and \>= 300.
Secondary Objectives:
* Assess vaccine immunogenicity after administration of a full Shingrix series schedule in PWH by age (\< 50 and \>= 50 years).
* Compare vaccine immunogenicity in PWH versus healthy volunteers.
* Evaluate grade 3 and 4 safety responses in PWH, based upon CD4 count (\< 300 and \>= 300), and healthy volunteers.
* Evaluate grade 3 and 4 safety responses in PWH, based upon age (\< 50 and \>= 50), and healthy volunteers.
Tertiary/Exploratory Objectives:
* Compare immune cell responses in PWH, based upon CD4 count (\< 300 and \>= 300), and healthy volunteers.
* Compare immune cell responses in PWH, based upon age (\< 50 and \>= 50 years), and healthy volunteers.
* Assess vaccine immunogenicity by varicella zoster serostatus.
* Assess zoster reactivation.
* Correlate the microbiome profile with vaccine responses.
Endpoints:
Primary Endpoint:
-Fold change of anti-glycoprotein gE (anti-gE) antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (\< 300 and \>= 300) run by GlaxoSmithKline (GSK).
Secondary Endpoints:
* Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by age (\< 50 and \>= 50) run by GSK.
* Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) in PWH and healthy volunteers run by GSK.
* Grade 3 and/or Grade 4 Shingrix AEs (solicited and unsolicited local and systemic).
Tertiary/Exploratory Endpoints:
* T-cell assays and phenotypes evaluated regularly through end of study.
* Varicella zoster serostatus as determined by IgG and IgM antibody levels.
* Number of episodes and severity of zoster reactivation (including extradermatomal complications such as neurologic or ophthalmologic complications and adverse sequelae such as post herpetic neuralgia).
* Baseline microbiome profile.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000866-I | None | None | View |