Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083330
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-05-20
Brief Title:
Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine VRC-HIVADV014-00-VP in Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2009-10-01
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 against HIV infection and see if it causes an immune response to HIV The vaccine is given by injection shot in the upper arm It is made from DNA that codes for three HIV proteins The DNA is inserted into an adenovirus that carries it into the muscle cells The adenovirus normally can cause eye or upper respiratory infections such as a cold however for the vaccine it has been modified so that it cannot cause illness Nor can the vaccine cause HIV infection because it codes for only three of the nine HIV proteins
Healthy normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study Candidates are screened with a medical history and physical examination and blood and urine tests
Participants are randomly assigned to receive either the experimental vaccine or a placebo an inactive substance that looks like the vaccine The vaccine or placebo is administered to participants in groups according to their entry into the study The first group receives the lowest study dose of vaccine If this dose is safe then the second group receives a higher dose If this dose is also safe then the third and final group receives the highest study dose Clinic staff observe the subjects for side effects for 30 minutes after the injection and subjects keep a diary card for the next 5 days recording their temperature and any symptoms that may appear Subjects are contacted by a nurse 2 days after the injection for follow-up
Participants are seen at the clinic for follow-up visits 1 2 4 12 and 24 weeks after the injection and then are contacted by telephone for follow-up once a year until 5 years after the injection The clinic visits include a physical examination medical history blood and urine tests and HIV counseling as needed Women have pregnancy tests at the screening evaluation and again at study week 24 All subjects are tested for HIV at screening and at study weeks 12 and 24 and all subjects complete a social impact questionnaire at week 24 All subjects are asked questions about their sexual behavior and drug use
Healthy normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study Candidates are screened with a medical history and physical examination and blood and urine tests
Participants are randomly assigned to receive either the experimental vaccine or a placebo an inactive substance that looks like the vaccine The vaccine or placebo is administered to participants in groups according to their entry into the study The first group receives the lowest study dose of vaccine If this dose is safe then the second group receives a higher dose If this dose is also safe then the third and final group receives the highest study dose Clinic staff observe the subjects for side effects for 30 minutes after the injection and subjects keep a diary card for the next 5 days recording their temperature and any symptoms that may appear Subjects are contacted by a nurse 2 days after the injection for follow-up
Participants are seen at the clinic for follow-up visits 1 2 4 12 and 24 weeks after the injection and then are contacted by telephone for follow-up once a year until 5 years after the injection The clinic visits include a physical examination medical history blood and urine tests and HIV counseling as needed Women have pregnancy tests at the screening evaluation and again at study week 24 All subjects are tested for HIV at screening and at study weeks 12 and 24 and all subjects complete a social impact questionnaire at week 24 All subjects are asked questions about their sexual behavior and drug use
Detailed Description:
Study Design
This is a Phase I randomized placebo-controlled double-blinded study to examine safety tolerability and immune response of a multiclade HIV adenoviral vector vaccine in uninfected adults The hypothesis is that this vaccine will be safe and elicit immune responses to HIV The primary objective is to evaluate the safety and tolerability of VRC-HIVADV014-00-VP in uninfected subjects and the secondary objectives include immunogenicity evaluations and adenovirus serotype 5 Ad5 antibody titers through Week 4 and social impacts at Week 24 Exploratory evaluations include immunogenicity evaluations at Weeks 12 and 24 and Ad5 antibody titers at Week 24
Product Description
VRC-HIVADV014-00-VP is a recombinant product composed of 4 adenoviral vectors Ad in a 3111 ratio that encode the HIV-1 GagPol polyprotein from clade B and HIV-1 Env glycoproteins from clades A B and C respectively The final formulation buffer VRC-DILUENT013-DIL-VP will be used as the diluent and as the placebo control Injections will be administered intramuscularly IM
Subjects
Healthy adult volunteers 18 to 44 years old
Study Plan
Thirty-six volunteers will receive one 10 mL injection of the study agent or placebo in a deltoid muscle as shown in the schema Dose escalation will occur about three weeks after the last injection in a dose group following an interim safety data review by a DSMB provided that there are no significant toxicities
Study Duration
Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection followed by annual telephone or mail contact for the subsequent 4 years
Study Endpoints
The primary endpoint is safety of the vaccine administered at doses of 1 x 109 1 x 1010 and 1 x 1011 particle units PU by intramuscular injection Secondary endpoints are immunogenicity as indicated by HIV-specific antibody and cellular immune responses through Week 4 Ad5 antibody titer at Week 0 and Week 4 and social impact at Week 24 Exploratory analyses of immunogenicity at Weeks 12 and 24 and Ad5 antibody titer at Week 24 will also be performed
This is a Phase I randomized placebo-controlled double-blinded study to examine safety tolerability and immune response of a multiclade HIV adenoviral vector vaccine in uninfected adults The hypothesis is that this vaccine will be safe and elicit immune responses to HIV The primary objective is to evaluate the safety and tolerability of VRC-HIVADV014-00-VP in uninfected subjects and the secondary objectives include immunogenicity evaluations and adenovirus serotype 5 Ad5 antibody titers through Week 4 and social impacts at Week 24 Exploratory evaluations include immunogenicity evaluations at Weeks 12 and 24 and Ad5 antibody titers at Week 24
Product Description
VRC-HIVADV014-00-VP is a recombinant product composed of 4 adenoviral vectors Ad in a 3111 ratio that encode the HIV-1 GagPol polyprotein from clade B and HIV-1 Env glycoproteins from clades A B and C respectively The final formulation buffer VRC-DILUENT013-DIL-VP will be used as the diluent and as the placebo control Injections will be administered intramuscularly IM
Subjects
Healthy adult volunteers 18 to 44 years old
Study Plan
Thirty-six volunteers will receive one 10 mL injection of the study agent or placebo in a deltoid muscle as shown in the schema Dose escalation will occur about three weeks after the last injection in a dose group following an interim safety data review by a DSMB provided that there are no significant toxicities
Study Duration
Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection followed by annual telephone or mail contact for the subsequent 4 years
Study Endpoints
The primary endpoint is safety of the vaccine administered at doses of 1 x 109 1 x 1010 and 1 x 1011 particle units PU by intramuscular injection Secondary endpoints are immunogenicity as indicated by HIV-specific antibody and cellular immune responses through Week 4 Ad5 antibody titer at Week 0 and Week 4 and social impact at Week 24 Exploratory analyses of immunogenicity at Weeks 12 and 24 and Ad5 antibody titer at Week 24 will also be performed
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 |
|---|---|---|---|
| 04-I-0172 | None | None | None |