Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050505
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2002-12-10
Brief Title:
Expanded Dryvax Dilution Study in Previously Vaccinated Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Double Blind Randomized Dose-response Study of Dryvax Vaccine Against Smallpox in Previously Vaccinated Adults
Status:
COMPLETED
Status Verified Date:
2009-07
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 determine the safety and effect of diluting smallpox vaccine making a larger number of doses in case smallpox is released into the environment A total of up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated against smallpox but not since 1989 will volunteer for this study for up to 34 weeks and receive different strengths of vaccine Some subjects may participate for longer if they choose to be revaccinated because the first vaccination does not take The vaccine will be given by making small cuts in the skin and putting the vaccine into these cuts After the screening visit volunteers will be followed through study visits and follow up phone calls Blood will be collected during some study visits to look at the immune system body system that fights infection response
Detailed Description:
The purposes of this multi-center double blind randomized dose response study are to evaluate the safety of undiluted Dryvax and Dryvax diluted at 15 and 110 in adults between the ages of 32 and 70 years who were previously vaccinated but not since 1989 and to define with very high precision -3 the proportion of individuals who respond with a take 6 to 11 days after vaccination with undiluted Dryvax vaccine and Dryvax diluted at 15 A take is defined as the formation of a lesion at the site of vaccination that is consistent with the description of a successful vaccination described in the IB Secondary study objectives include defining with good precision - 10 the proportion of individuals who respond with a take 6 to 11 days after vaccination with a 110 dilution of Dryvax vaccine and exploring correlations between takes no-take and immune responses in all vaccine groups antibody responses in all volunteers and assays of cell-mediated immunity in a convenience sample consisting of 15 volunteers enrolled at each site total N 105 randomly distributed across the vaccine groups Immunogenicity assays will include neutralizing antibody to vaccinia vaccinia binding antibody ELISPOT for gamma interferon Assays of cell-mediated immunity will be performed only on a convenience sample consisting of 15 volunteers enrolled at each site total N 105 and intracellular cytokine production Primary safety endpoints include safety data regarding the three doses of vaccine in previously vaccinated subjects as assessed by adverse events reported by the subjects andor investigators and changes observed during the scheduled clinic visits Specific attention will be paid to the following local reactogenicity at the site of injection pain tenderness erythema induration regional lymphadenopathy limitation of limb movement systemic symptoms fever myalgia fatigue and headache anaphylaxis and hypersensitivity reactions other reactions dermatologic neurologic gastrointestinal nauseavomiting diarrhea The primary efficacy endpoint for this trial will be the proportion of vaccinees demonstrating a take 6 to 11 days after the first vaccination at each of the dose levels undiluted and 15 and 110 Secondary endpoints are immune responses as assessed by vaccinia neutralizing antibody measured on all subjects and binding antibody to vaccinia on all subjects and the size of the lesions observed in all subjects compared across the dilution groups Tertiary endpoints of 15 volunteers at each site randomly distributed across the vaccine groups are cellular immune responses as assessed by ELISPOT for gamma interferon in response to vaccinia antigens and intracellular cytokine production
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