Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults.
Himal Lal, Anthony L Cunningham, Olivier Godeaux...
https://pubmed.ncbi.nlm.nih.gov/25916341Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID05580458
Phase 1/2 Open-label Trial Evaluating Safety and Immune Response to Shingrix Vaccine in People With HIV and Healthy Volunteers
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-05
225
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the immune response to the Shingrix vaccine in people with HIV and healthy adults aged 50 and older. The study focuses on how the vaccine affects those with different CD4 counts in people with HIV. It also compares immune responses and safety between people with HIV and healthy volunteers, aiming to understand vaccine effects in these groups. Participants will receive two doses of the Shingrix vaccine by injection in the upper arm, given about two months apart. The study includes blood and urine tests, physical exams, and rectal swabs to collect bacteria samples. Some participants may undergo apheresis, a process where white blood cells are separated from the blood. Follow-up visits occur at 3 and 12 months after the first dose. Participants will attend at least four clinic visits over one year. They will track symptoms using a 28-day memory tool and may receive up to four phone calls to discuss side effects. Researchers will measure antibody levels, immune cell responses, and monitor for any adverse events. The study includes regular evaluations to assess vaccine safety and immune response over the 12-month period.
CONDITIONS
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
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent.
- Participants of childbearing potential must agree to use at least one acceptable contraception method from screening through month 3.
- Has a primary care provider.
- People with HIV must be 18 years or older.
- People with HIV must be seropositive for HIV-1.
- People with HIV must have documented viral load under 100 copies/mL within 90 days before screening and consistent viral suppression.
- People with HIV must be on a stable antiretroviral regimen for at least 6 months or be an elite controller.
- No active or uncontrolled opportunistic infections in people with HIV.
- Healthy volunteers must be 50 years or older.
- Healthy volunteers must have no uncontrolled chronic medical issues that compromise safety.
- Healthy volunteers must have no underlying immunodeficiencies including HIV.
You will not qualify if you...
- Previous receipt of Shingrix vaccine at any time.
- Receipt of Zostavax within the past 12 months.
- History of severe allergic reaction to any component of Shingrix.
- Diagnosed varicella or herpes zoster episode within the past 1 month.
- Immunocompromised from causes other than HIV within the past 6 months.
- Current moderate or severe acute illness.
- Pregnancy or breastfeeding.
- Receipt of investigational agents or live virus vaccines within 30 days prior to screening.
- Planned receipt of certain vaccines between months 0 and 2 except TDaP, Pneumovax, influenza, and COVID-19 vaccines with specific timing.
- Administration of immunoglobulins or blood products within 90 days before first vaccine dose.
- Chronic use of immunosuppressive drugs within 6 months before screening (with exceptions).
- Uncontrolled psychiatric disease, current substance use, or inappropriate conduct.
- Any condition compromising safety or study outcomes as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 months
Participants receive two doses of the Shingrix vaccine by intramuscular injection approximately 2 months apart. Blood is collected prior to each dose to assess immune response.
2 vaccination visits (in-person) with blood collection prior to each dose
Follow-up
Duration - 10 months
Participants attend follow-up visits to monitor safety and immune response after vaccination, including assessments of adverse events and blood sample collection.
2 follow-up visits at months 3 and 12 (in-person) with blood collection
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Loading map...
Research Team
M
Maura M Manion, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study.
Elchonon M Berkowitz, Graeme Moyle, Hans-Jürgen Stellbrink...
https://pubmed.ncbi.nlm.nih.gov/25371534