Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053742
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-02-04
Brief Title:
Phase III Trial of Modified Vaccinia Virus Ankara MVA Vaccine Against Smallpox
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase III Clinical Trial of Modified Vaccinia Virus Ankara MVA to Evaluate Its Safety Immunogenicity and Protective Efficacy Against Dryvax Registered Trademark Challenge in Vaccinia-Immune Individuals
Status:
COMPLETED
Status Verified Date:
2006-03
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:
This study will test the safety of an experimental vaccine called modified vaccinia virus ankara MVA and determine if it confers protection against the smallpox virus variola There is an existing vaccine called Dryvax Registered Trademark which is effective against smallpox however this vaccine can cause various side effects including some that on rare occasions can be life-threatening Dryvax Registered Trademark has not been used in the United States since childhood vaccination was stopped in 1971 and though it is given to certain healthcare and laboratory workers and some people in the armed forces it is not recommended for the general population Both the MVA and Dryvax Registered Trademark vaccines are made using the vaccinia virus which is closely related to variola
Healthy normal volunteers between 31 and 60 years of age who have been vaccinated with a smallpox vaccine more than 10 years before entering the study may be eligible for this protocol Candidates will be screened with a medical history physical examination and blood and urine tests including an HIV test and a pregnancy test for women of childbearing potential
Participants will receive MVA vaccine or placebo followed by a dose of Dryvax Registered Trademark The MVA vaccine and placebo are injected into an arm muscle with a needle and syringe The Dryvax Registered Trademark vaccine is administered with a special forked needle that is poked lightly into the skin of the upper arm usually 15 times in a process called scarification When the vaccine works a small pus-filled blister forms followed by a scab and then scarring at the site of the vaccination The formation of the blister and scab is called a take indicating that the vaccine is effective and will protect against smallpox for at least a few years If scarification does not take it can either mean that the person already has immunity or that the vaccine did not work
Study participants will be randomly assigned to one of the following dosing groups 1 one injection of MVA 2 one injection of placebo 3 two injections of MVA 4 weeks apart or 4 two injections of placebo 4 weeks apart All participants will receive a challenge dose of Dryvax Registered Trademark 12 weeks after their last injection of MVA or placebo to determine if the MVA vaccine has conferred immunity A take that occurs in response to the Dryvax Registered Trademark dose indicates lack of prior immunity and thus tells whether one or two doses of MVA is needed to produce an immune response
Participants will be observed for at least 1 hour after each injection They will come to the clinic at least once a week after MVA or placebo injections and at least twice a week after Dryvax Registered Trademark to have the injection site evaluated and photographed At each visit participants will be asked how they are feeling and what medications if any they are taking Blood and urine tests will be done according to the following schedule
Before each injection
1 week after each injection
4 weeks after the MVA or placebo injections are finished
At the time of the Dryvax Registered Trademark dose
4 weeks after the Dryvax Registered Trademark dose
12 weeks after the Dryvax Registered Trademark dose
Additional laboratory tests may be done between visits if medically necessary
Healthy normal volunteers between 31 and 60 years of age who have been vaccinated with a smallpox vaccine more than 10 years before entering the study may be eligible for this protocol Candidates will be screened with a medical history physical examination and blood and urine tests including an HIV test and a pregnancy test for women of childbearing potential
Participants will receive MVA vaccine or placebo followed by a dose of Dryvax Registered Trademark The MVA vaccine and placebo are injected into an arm muscle with a needle and syringe The Dryvax Registered Trademark vaccine is administered with a special forked needle that is poked lightly into the skin of the upper arm usually 15 times in a process called scarification When the vaccine works a small pus-filled blister forms followed by a scab and then scarring at the site of the vaccination The formation of the blister and scab is called a take indicating that the vaccine is effective and will protect against smallpox for at least a few years If scarification does not take it can either mean that the person already has immunity or that the vaccine did not work
Study participants will be randomly assigned to one of the following dosing groups 1 one injection of MVA 2 one injection of placebo 3 two injections of MVA 4 weeks apart or 4 two injections of placebo 4 weeks apart All participants will receive a challenge dose of Dryvax Registered Trademark 12 weeks after their last injection of MVA or placebo to determine if the MVA vaccine has conferred immunity A take that occurs in response to the Dryvax Registered Trademark dose indicates lack of prior immunity and thus tells whether one or two doses of MVA is needed to produce an immune response
Participants will be observed for at least 1 hour after each injection They will come to the clinic at least once a week after MVA or placebo injections and at least twice a week after Dryvax Registered Trademark to have the injection site evaluated and photographed At each visit participants will be asked how they are feeling and what medications if any they are taking Blood and urine tests will be done according to the following schedule
Before each injection
1 week after each injection
4 weeks after the MVA or placebo injections are finished
At the time of the Dryvax Registered Trademark dose
4 weeks after the Dryvax Registered Trademark dose
12 weeks after the Dryvax Registered Trademark dose
Additional laboratory tests may be done between visits if medically necessary
Detailed Description:
This is a phase III randomized placebo-controlled double-blinded study of MVA vaccine The hypothesis is that MVA will be safe in vaccinia-immune adults when administered by intramuscular injection and that this vaccine will result in an immunologic response comparable to that observed after Dryvax Registered Trademark vaccination in previously vaccinia-immunized persons The primary objectives include evaluating the safety of MVA administered by intramuscular IM injection at 108 PFU and determining whether MVA provides clinical evidence of protection against a 12-week Dryvax challenge when compared to placebo groups The secondary objectives are to identify the schedules of MVA administration that provide clinical evidence of protection against Dryvax Registered Trademark challenge and compare the Immunogenicity of Dryvax Registered Trademark and MVA as measured by vaccinia-specific neutralizing antibody ELISA and intracellular cytokine assays as well as variola-specific neutralizing antibody assays that will be conducted at the CDC on a subset of samples
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 |
|---|---|---|---|
| 03-I-0087 | None | None | None |