Phase 1
N=223
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01385566 ↗Enrolled (actual)
223
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies — 1.74; 1.64; 3.24; 2.45 Geometric mean fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous (Biological); ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous (Biological); ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal (Biological); ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal (Biological); Full Dose Intradermal Placebo (Biological); Intradermal Placebo (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies |
1.74; 1.64; 3.24; 2.45; 2.21; 1.64 | — |
| PRIMARY Number of Participants Reporting an Adverse Experience (AE) |
30; 10; 27; 23; 21; 19 | — |
| PRIMARY Number of Participants Reporting a Serious Adverse Experience (SAE) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting a Serious Adverse Experience |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) |
27; 7; 27; 22; 19; 19 | — |
| PRIMARY Number of Participants Reporting Systemic Adverse Experiences |
12; 6; 6; 4; 5; 6 | — |
| PRIMARY Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) |
0; 0; 0; 0; 0; 0 | — |
Summary
This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.
Eligibility Criteria
Inclusion Criteria
- Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
- Temperature less than 100.4 °F on day of vaccination
- Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
- In good health
Exclusion Criteria
- History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
- Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
- Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
- Prior history of herpes zoster
- Prior receipt of any varicella or zoster vaccine
- Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
- On immunosuppressive therapy
- Known or suspected immune dysfunction
- Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
- Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
- Not ambulatory
- Pregnant or breastfeeding
- Use of nontopical antiviral therapy with activity against herpes viruses
- Active untreated tuberculosis
Data sourced from ClinicalTrials.gov (NCT01385566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.