Phase 1
N=290
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00696709 ↗Enrolled (actual)
290
Serious AEs
0.7%
Results posted
Nov 2019
Primary outcome: Primary: Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients — 2.18 Ratio — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Comparator: V212 (Biological); Comparator: Placebo (Biological)
- Age
- Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients |
2.18 | <0.0001 sig |
| PRIMARY Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients |
1.90 | <0.0001 sig |
| PRIMARY Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients |
1.58 | <0.0001 sig |
| PRIMARY Percentage of Participants With a Serious Adverse Event |
0.0; 1.6; 0.0; 1.6; 0.0 | — |
| PRIMARY Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card |
57.8; 62.3; 21.9; 63.5; 50.8 | <0.001 sig |
| PRIMARY Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card |
45.3; 54.1; 50.0; 52.4; 41.5 | — |
| PRIMARY Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card |
1.6; 1.6; 0.0; 3.2; 1.5 | 0.480 |
| PRIMARY Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event |
0.0; 0.0; 0.0; 1.6; 0.0 | — |
| SECONDARY Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA |
2.10 | <0.0001 sig |
Summary
The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.
Eligibility Criteria
Inclusion Criteria
- Must be 50 to 59 years of age
- No fever on vaccination days
- Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
- Females of child-bearing potential must use acceptable forms of birth control
Exclusion Criteria
- Prior history of shingles
- Prior receipt of any chickenpox or shingles vaccine
- Pregnant or breastfeeding
- Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
- Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
- Received immunoglobulin or blood products
- Receiving treatment that may weaken the immune system
- Have an immune system disorder
Data sourced from ClinicalTrials.gov (NCT00696709). 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.