CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
MVA Smallpox Vaccine +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00133575
NCT00133575Phase 2Completed
CompareCT.gov

ACAM 3000 MVA (Acambis Modified Vaccinia Ankara) Immunization Followed by Dryvax® Vaccination of Healthy Vaccinia-Naïve Adults: A Phase I/II, Placebo-Controlled Study of the Effects of Dose and Route of Administration of MVA on Safety, Reactogenicity and Immunogenicity, Followed by Dryvax® Immunization to Assess Effects of MVA Vaccination on Dryvax® Takes

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 23, 2005·Updated Jan 5, 2015

In Brief

A Phase 2 clinical trial evaluating MVA Smallpox Vaccine, Placebo, and 1 other intervention for Smallpox. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA: Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease) response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax® 6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6 months after the initial MVA vaccine. Study procedures will include documenting side effects for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and blood samples. Participants will be involved in study related procedures for up to 18 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 23, 2005
Enrollment StartOct 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.9 years ago

Interventions

MVA Smallpox Vaccinebiological

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 intramuscularly (IM).

MVA Smallpox Vaccinebiological

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 subcutaneously (SC).

Placeboother

Sterile saline (0.9%) volume of 0.5 ml intradermally in the deltoid.

Placeboother

Sterile saline (0.9%) volume of 0.5 ml subcutaneously in the deltoid.

MVA Smallpox Vaccinebiological

MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^6 or 10\^7 TCID50 intradermally (ID).

Live vaccinia virus vaccinebiological

Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.

Placeboother

Sterile saline (0.9%) volume of 0.5 ml intramuscularly in the deltoid.