Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133575
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2005-08-19
Brief Title:
ACAM 3000 MVA at Harvard Medical School
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
ACAM 3000 MVA Acambis Modified Vaccinia Ankara Immunization Followed by Dryvax Vaccination of Healthy Vaccinia-Naïve Adults A Phase III 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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety of an experimental smallpox vaccine MVA Modified Vaccinia Ankara and to compare the bodys 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
Detailed Description:
The emergence of smallpox as a potential agent of bioterrorism has heightened concern about the vulnerability of the population to infection with this agent and has led to proposals to undertake large scale smallpox immunization of military personnel and first responders in the United States including certain health care workers A particularly promising vaccine approach to the development of an effective yet less reactogenic vaccine to smallpox is the use of Modified Vaccinia Ankara MVA as a vaccine Despite the established efficacy of smallpox vaccination the parameters of protective immunity against smallpox infection are incompletely understood This is a phase III trial to be conducted under a placebo controlled double-blind randomized allocation of study product The purpose of this study is to assess the safety and immunogenicity of ACAM 3000 MVA in healthy vaccinia-naïve adult subjects Participants will include 72 healthy male or female from the Boston metropolitan area Six dose regimens will be studied initially 106 or 107 tissue culture infectious dose 50 TCID50 administered intradermally and 107 or 108 TCID50 administered intramuscularly or subcutaneously as 2 immunizations 1 month apart Each arm will be comprised of 12 subjects 10 of whom will receive ACAM3000 MVA and 2 of whom will receive placebo A subsequent vaccinia vaccination will be offered to all patients Consenting participants in Groups A and B will receive the vaccinia Dryvax inoculation between 6 and 15 months after the initial MVA placebo vaccination Consenting participants in groups C D E and F will receive the Dryvax inoculation approximately 6 months after the initial MVA placebo vaccination coinciding with planned visit 13 Assessment of safety will be carried out by observation and measurement of acute clinical and laboratory evidence of reactions or toxicity including clinical electrocardiographic or laboratory evidence of myopericarditis Assessment of immunogenicity will be carried out by the measurement of humoral and cell-mediated immune response to ACAM 3000 MVA and vaccinia performed on blood samples obtained at various times prior to and after immunization over the one year period of the study Response to vaccinia will be assessed clinically effect on a take and the results will be correlated with immune responses to MVA Subjects will be followed for reactogenicity Clinical assessments and blood samples will be obtained sequentially for immunogenicity determinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U54AI057159-10 | NIH | None | httpsreporternihgovquickSearch5U54AI057159-10 |