Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109629
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-04-29
Brief Title:
Prime-Boost Vaccine Schedule for Prevention of HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
VRC 008 A Phase I Clinical Trial of a Prime-Boost HIV-1 Vaccination Schedule Multiclade DNA Vaccine VRC-HIVDNA016-00-VP Followed by Multiclade Adenoviral Vector Vaccine VRC-HIVADV014-00-VP in Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2008-01-22
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 determine the safety and side effects of two experimental HIV vaccines given in a prime-boost schedule It will also monitor participants for the social impact of being in an HIV vaccine study eg problems with insurance health care friends family employment housing and so forth The vaccines are VRC-HIVDNA016-00-VP called the DNA vaccine and VRC-HIVADV014-00-VP called the rAd vaccine The DNA vaccine codes for four HIV proteins The rAd vaccine is made using an adenovirus a common virus that causes upper respiratory infections such as the common cold that has been modified to contain DNA that codes for three HIV proteins These vaccines cannot cause HIV or adenoviral infections
The study will also see if the vaccines cause an immune response if the injection of the DNA vaccine given using a needle and syringe is similar in safety and immune response to giving them with a needleless injection device called a Biojector 2000 if people who already have antibodies to adenovirus still have an immune response to rAd vaccine and if there are social harms that result from participating in an HIV vaccine study
Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study Candidates are screened with a medical history physical examination blood and urine tests including pregnancy test for women and questions regarding sexual behavior and other practices
Participants receive three injections shots of the DNA vaccine and one injection of the rAd vaccine All injections are given into a muscle in the upper arm alternating right and left arms with each injection using a needle and syringe or the needleless Biojector 2000 The first vaccination is given the day of enrollment into the study and the DNA vaccinations are given about 4 weeks apart from each other with a minimum of 21 days between injections The rAd boostervaccination is given at Week 24 Participants fill out a diary card at home for 5 days after each vaccination recording their temperature and any symptoms They come to the clinic for follow-up 3 days each DNA vaccine injection and call or return again 7 days after each injection They call a study nurse 1 or 2 days after the rAd injection
There are 15 to 18 clinic visits during the course of the study At each visit participants are checked for health changes or problems Blood and urine samples are collected at some visits Participants are periodically tested for HIV and asked questions about their sexual behavior and drug use and are counseled throughout the study on HIV risk reduction They are also asked about any social effects they may have experienced as a result of their participation in this study
The study will also see if the vaccines cause an immune response if the injection of the DNA vaccine given using a needle and syringe is similar in safety and immune response to giving them with a needleless injection device called a Biojector 2000 if people who already have antibodies to adenovirus still have an immune response to rAd vaccine and if there are social harms that result from participating in an HIV vaccine study
Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study Candidates are screened with a medical history physical examination blood and urine tests including pregnancy test for women and questions regarding sexual behavior and other practices
Participants receive three injections shots of the DNA vaccine and one injection of the rAd vaccine All injections are given into a muscle in the upper arm alternating right and left arms with each injection using a needle and syringe or the needleless Biojector 2000 The first vaccination is given the day of enrollment into the study and the DNA vaccinations are given about 4 weeks apart from each other with a minimum of 21 days between injections The rAd boostervaccination is given at Week 24 Participants fill out a diary card at home for 5 days after each vaccination recording their temperature and any symptoms They come to the clinic for follow-up 3 days each DNA vaccine injection and call or return again 7 days after each injection They call a study nurse 1 or 2 days after the rAd injection
There are 15 to 18 clinic visits during the course of the study At each visit participants are checked for health changes or problems Blood and urine samples are collected at some visits Participants are periodically tested for HIV and asked questions about their sexual behavior and drug use and are counseled throughout the study on HIV risk reduction They are also asked about any social effects they may have experienced as a result of their participation in this study
Detailed Description:
Study Design This is a Phase I randomized study to examine safety and tolerability of as well as immune response to a schedule of 3 HIV DNA plasmid vaccinations followed by one HIV adenoviral vector vaccine rAd booster The hypotheses are that 1 this regimen will be safe for human administration and elicit immune responses to HIV-1 2 Biojector and NeedleSyringe are both safe to use for IM injection of the DNA vaccine and 3 subjects with both low and high pre-existing adenovirus serotype 5 antibody Ad5Ab titer will have a boost in immune response to HIV-1 peptides following the Ad booster vaccination In this study equal numbers of subjects with high and low Ad5Ab titers will be randomized to receive DNA vaccinations by either needle and syringe NS or by Biojector and then to receive either 1010 PU or 1011 PU rAd booster vaccination in a factorial design The primary objective is to evaluate the safety and tolerability in humans of the prime-boost vaccination regimen Secondary objectives are related to evaluation of the immunogenicity of the DNA vaccine when administered by NS or Biojector the immunogenicity of the Ad vaccine at two different doses in subjects with high and low pre-enrollment titers of Ad5Ab the development of adenovirus serotype 5 neutralizing antibody and the social impact of participating in an HIV-1 vaccine trial Exploratory evaluations of the immunogenicity of the prime-boost regimen are also planned The preliminary results may serve as the basis for designing studies to provide more definitive answers to questions about method of administration and effect of pre-enrollment Ad5Ab titer on safety of and immune response to the rAd booster vaccination
Product Description VRC-HIVDNA016-00-VP is composed of 6 closed circular DNA plasmids that are each 1667 by weight of the vaccine Each of the 6 plasmids in this vaccine expresses a single gene product Plasmids VRC 4401 VRC 4409 and VRC 4404 are designed to express clade B HIV-1 Gag Pol and Nef respectively VRC 5736 VRC 5737 and VRC 5738 are designed to express HIV-1 Env glycoprotein from clade A clade B and clade C respectively Vaccine vials will be supplied at 4 mgmL DNA vaccinations will be 1 mL of vaccine administered intramuscularly using either NS or the Biojector 2000 Needle-Free Injection Management System VRC-HIVADV014-00-VP is a recombinant product composed of four non-replicating adenoviral vectors in a 3111 ratio that code for HIV-1 GagPol polyproteins from clade B and HIV-1 Env glycoproteins from clades A B and C All rAd injections will be administered by NS
Subjects Forty healthy adult volunteers 18 to 50 years old 20 subjects with low Ad5Ab 1500 and 20 subjects with high Ad5Ab greater than 1500
Study Plan Forty subjects will be randomized in a 11 ratio to receive the same vaccination schedule but by two different methods of intramuscular administration NS or Biojector as shown in the schema The rAd boost will also be randomized to be either 1010 PU or 1011 PU in 11 ratio The rAd boost dosage will be blinded until 6 weeks of safety and immunogenicity evaluations after the rAd boost are completed for all subjects
Product Description VRC-HIVDNA016-00-VP is composed of 6 closed circular DNA plasmids that are each 1667 by weight of the vaccine Each of the 6 plasmids in this vaccine expresses a single gene product Plasmids VRC 4401 VRC 4409 and VRC 4404 are designed to express clade B HIV-1 Gag Pol and Nef respectively VRC 5736 VRC 5737 and VRC 5738 are designed to express HIV-1 Env glycoprotein from clade A clade B and clade C respectively Vaccine vials will be supplied at 4 mgmL DNA vaccinations will be 1 mL of vaccine administered intramuscularly using either NS or the Biojector 2000 Needle-Free Injection Management System VRC-HIVADV014-00-VP is a recombinant product composed of four non-replicating adenoviral vectors in a 3111 ratio that code for HIV-1 GagPol polyproteins from clade B and HIV-1 Env glycoproteins from clades A B and C All rAd injections will be administered by NS
Subjects Forty healthy adult volunteers 18 to 50 years old 20 subjects with low Ad5Ab 1500 and 20 subjects with high Ad5Ab greater than 1500
Study Plan Forty subjects will be randomized in a 11 ratio to receive the same vaccination schedule but by two different methods of intramuscular administration NS or Biojector as shown in the schema The rAd boost will also be randomized to be either 1010 PU or 1011 PU in 11 ratio The rAd boost dosage will be blinded until 6 weeks of safety and immunogenicity evaluations after the rAd boost are completed for all subjects
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 |
|---|---|---|---|
| 05-I-0148 | None | None | None |