A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Herpes Zoster

Treatments: Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal; Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal; Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous; Biological: Full Dose Intradermal Placebo; Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous; Biological: Intradermal Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01385566

V211-051

Details and patient eligibility

About

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Full description

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Enrollment: 223 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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223 participants in 6 patient groups

Full Dose Subcutaneous

Active Comparator group

Description:

Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.

Treatment:

Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous

Biological: Intradermal Placebo

1/3 Dose Subcutaneous

Experimental group

Description:

Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Treatment:

Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous

Biological: Intradermal Placebo

Full Dose Intradermal

Experimental group

Description:

Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Treatment:

Biological: Full Dose Intradermal Placebo

Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal

1/3 Dose Intradermal

Experimental group

Description:

Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Treatment:

Biological: Intradermal Placebo

Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal

1/10 Dose Intradermal

Experimental group

Description:

Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Treatment:

Biological: Intradermal Placebo

Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal

1/27 Dose Intradermal

Experimental group

Description:

Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

Treatment:

Biological: Intradermal Placebo

Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal