Clinical trial NCT00681031: Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
Official title: An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination.

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.


Eligibility criteria: Inclusion Criteria:

* Participant of either gender aged ≥50 years
* Positive history of varicella or residence for \>30 years in a country with endemic VZV infection
* All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
* Participant having signed the informed consent form prior to any study procedure

Exclusion Criteria:

* Febrile within 72 hours prior to vaccination
* Prior history of Herpes Zoster clinically diagnosed by a physician
* Previously received a varicella or zoster vaccine
* Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
* Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
* Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
* Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
* Taking any non topical antiviral therapy with activity against herpesviruses.
* On immunosuppressive therapy
* Known or suspected immune dysfunction caused by a medical condition, or any other cause
* History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
* Known active tuberculosis
* Significant underlying illness preventing completion of the study

Primary outcomes:
measure: Geometric Mean Titre (GMT) of Varicella Antibodies
timeFrame: Predose (Day 0) and Day 28-35 Post Dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Arnou R, Fiquet A, Thomas S, Sadorge C. Immunogenicity and safety of ZOSTAVAX((R)) approaching expiry potency in individuals aged >/=50 years. Hum Vaccin. 2011 Oct;7(10):1060-5. doi: 10.4161/hv.7.10.16480. Epub 2011 Oct 1.