Completed

The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination

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What is being tested

ACAM3000 MVA Vaccine

Biological
Who is being recruted

DNA Virus Infections
+3

+ Infections
+ Poxviridae Infections
From 18 to 31 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Phase 1
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorSanofi Pasteur, a Sanofi Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated. Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine. The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus. The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.

Official TitleThe Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination 
NCT00079820
Principal SponsorSanofi Pasteur, a Sanofi Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
110 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 31 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
DNA Virus Infections
Infections
Poxviridae Infections
Smallpox
Vaccinia
Virus Diseases
Criteria

Inclusion Criteria: Subjects must meet the following to be eligible for the study: * adult males or females who provided informed consent for the study. * adults 18 and 31 years (inclusive). * good general health, * female subjects must not be pregnant or lactating and be on appropriate contraception or be a female unable to bear children. * subjects be available for participation during the entire study. Exclusion Criteria: Any of the following exclusion criteria are met, the subject is NOT eligible. * military service prior to 1989 or after December 13th, 2002. * history of previous smallpox vaccination * known/suspected history of immunodeficiency, or with current radiation treatment or use of immunosuppressive or anti-neoplastic drugs. * subjects with a household member or intimate contact with the same conditions listed above. * known or suspected impairment of other immunologic function. * malignancy, including squamous cell or basal cell skin cancer at vaccination site * active autoimmune disease. * subjects with known eye diseases or other conditions that require the use of corticosteroid eye drops. * known/history of cardiac disease. * subjects who have been diagnosed with 3 or more of the following risk factors for ischemic coronary disease: a) high blood pressure b) elevated blood cholesterol levels c) diabetes or high blood sugar d) first degree relative (for example, mother, father, brother, or sister) who had a heart condition before the age of 50 e) smoke cigarettes * subjects with a history of palpitations or abnormalities of cardiac rhythm. * subjects with odd ECG patterns * subjects with a ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years. * positive or elevated creatinine kinase, CK-MB, or Troponin I laboratory test levels. * abnormalities of clinical laboratory assessments. * past history or current diagnosis of chronic renal disease, adverse reactions to drugs characterized by renal impairment, a serum creatinine \> 1.5 mg/dL, or presence of 1+ protein in urinalysis at screening and a calculated creatinine clearance of not less than 80 mL/min. * current diagnosis or past history of eczema. * subjects with a household member or intimate contact with the same conditions listed above. * presence of acute, chronic, or exfoliative skin conditions, open wounds, or burns. * history of keloid formation. * known allergies to MVA or to any known components (Neomycin, Gentamycin) of the vaccine. * known allergy to eggs or egg products. * known allergies to any component of the Dryvax® vaccine. Antibiotics in Dryvax® include neomycin, streptomycin, chlortetracycline, and polymixin B. * known allergies to any known component of the Dryvax® diluent (i.e., glycerin and phenol). * known allergies to any known component of VIG, (i.e., thimerosal or previous allergic reaction to immunoglobulins). * known allergies to cidofovir or sulphur containing drugs, including probenecid, trimethoprim, and sulfonamide antibiotics. * transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 6 months of the screening visit. * positive serology result for HIV, hepatitis B surface antigen, or hepatitis C. * current diagnosis or history within six months of the screening visit of drug or alcohol abuse disorders. * significant acute or chronic psychiatric illness. * female subjects with a positive serum pregnancy test result * subjects with a household member or direct contact with someone who is pregnant or lactating. * temperature or acute illness within 3 days prior to vaccination * inoculation with an inactivated vaccine with 14 days of Day 0 or with a live attenuated vaccine within 30 days of Day 0. * subjects who have participated in another investigational drug or vaccine trial within 30 days of Day 0. * subjects who are planning on donating blood or organs within 30 days of vaccination.


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
5 intervention groups 

are designated in this study

20% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
MVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Group II
Experimental
MVA3000 Smallpox vaccine (1x10-8) with no Challenge

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Group III
Placebo
Placebo

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Group IV
Experimental
MVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Group 5
Experimental
MVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112

Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
PRA InternationalLenexa, United StatesSee the location
Suspended
University of Kentucky Medical CenterLexington, United States

Completed2 Study Centers
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