Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

NCT ID: NCT00053482

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2003-10-31

Brief Summary

The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

Detailed Description

Specifically, the objectives of this study are to:

1. Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.

2. Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing:

1. the proportion of subjects at each dose level who develop a major cutaneous reaction

2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.

3. Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.

Conditions

Smallpox

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: ACAM2000

Participants will receive dose 1 of the ACAM2000 smallpox vaccine

Group Type: EXPERIMENTAL

ACAM2000 Smallpox Vaccine

Intervention Type: BIOLOGICAL

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Group 2: ACAM2000

Participants will receive dose 2 of the ACAM2000 smallpox vaccine

Group Type: EXPERIMENTAL

ACAM2000 Smallpox Vaccine

Intervention Type: BIOLOGICAL

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Group 3: ACAM2000

Participants will receive dose 3 of the ACAM2000 smallpox vaccine

Group Type: EXPERIMENTAL

ACAM2000 Smallpox Vaccine

Intervention Type: BIOLOGICAL

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Group 4: ACAM2000

Participants will receive dose 4 of the ACAM2000 smallpox vaccine

Group Type: EXPERIMENTAL

ACAM2000 Smallpox Vaccine

Intervention Type: BIOLOGICAL

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Group 5: Dryvax®

Participants will receive dose 1 of Dryvax® smallpox vaccine.

Group Type: ACTIVE_COMPARATOR

Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®

Intervention Type: BIOLOGICAL

Group 5 dose: 1.0x10-8th PFU/ml

Interventions

ACAM2000 Smallpox Vaccine

Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml

Intervention Type: BIOLOGICAL

Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®

Group 5 dose: 1.0x10-8th PFU/ml

Intervention Type: BIOLOGICAL

Other Intervention Names

Dryvax®

Eligibility Criteria

Inclusion Criteria

• have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.
• females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
• agree to be available for the entire study and agree to comply with all requirements.

Exclusion Criteria

• children 1 year of age or younger in the household or be in close contact
• smallpox vaccination within ten years
• known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
• renal disease
• current or past history of eczema or a household member or direct contact who has eczema.
• known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
• known allergy or past allergic reaction to blood products.
• known allergy to cidofovir or sulfa-containing drugs.
• history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
• transfusion of blood or treatment with any blood product.
• current or history of drug or alcohol abuse
• innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

• Minimum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Emergent BioSolutions

Locations

PRA International

Lenexa, Kansas, United States

Bio-Kinetic Clinical Applications

Springfield, Missouri, United States

Memorial Hospital of Rhode Island Division of Infectious Diseases

Pawtucket, Rhode Island, United States

Countries

United States

Other Identifiers

H-400-003

Identifier Type: -

Identifier Source: org_study_id