Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection
|First Received Date ICMJE||June 28, 2008|
|Last Updated Date||March 16, 2013|
|Start Date ICMJE||June 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Safety (local and systemic reactogenicity, lab tests, AEs)|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00709605 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Immunogenicity (cellular and humoral immune function assays)|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection|
|Official Title ICMJE||A Phase I, Open Label, CT to Evaluate the Safety, Tolerability and Immunogenicity of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP In Uninfected Adults Randomized to Needle or Biojector Methods of Intramuscular Injection|
This study will compare the immune response and side effects of an experimental HIV vaccine given by two different methods of administration - by needle injection or by use of a needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections.
Healthy volunteers who are not infected with the HIV virus may be eligible for this study. Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50 years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18 to 55 years old and participated in a prior study in which they received at least one injection of the study rAd5 vaccine.
Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector 2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days after the injection, record their temperature and symptoms on a diary card at home for 5 days after the injection for later review, and visit the clinic two weeks after the injection for a checkup.
The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2, 4, 12 and 24, when subjects are checked for health changes or problems, their use of medications and how they are feeling. Blood samples are collected at all clinic visits. Subjects are tested for HIV at the beginning and end of the study, are asked about their sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested for pregnancy at the beginning and end of the study.
Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to collect white blood cells for tests to examine the immune response to the vaccine. Blood is collected through a needle in the vein of one arm and directed through a machine that separates the cell components. The white cells are removed and the rest of the blood is returned through the same needle.
Subjects are asked about any social effects they may have experienced from participating in the study. These effects are monitored to make sure participants receive any needed assistance and to learn ways to prevent these problems in the future.
VRC 015 will examine safety, tolerability and immune response to the VRC recombinant adenoviral vector serotype 5 vector vaccine, VRC-HIVADV014-00-VP (rAd5), in uninfected subjects who will be randomized to receive the injection either by needle or Biojector injection. The study will include enrollment of rAd5 vaccine-naive subjects, as well as enrollment of rollover subjects who received at least one rAd5 injection in a prior study that included the rAd5 vaccine. The hypothesis is that the rAd5 vaccine will be safe and immunogenic when administered by either needle or Biojector. The primary objectives are to evaluate the safety and tolerability of the rAd5 vaccine at 10(10) PU dosage in the naive and previously vaccinated, uninfected subjects when administered by needle or Biojectors. The secondary objectives include evaluating the HIV-1-specific humoral and T-cell immune responses and adenovirus serotype 5 (Ad5) antibody responses, and social impacts of participation in an HIV vaccine study. Exploratory evaluations include epitope mapping and other immunogenicity evaluations.
The VRC HIV rAd5 vaccine is a recombinant product composed of 4 adenoviral vectors (in a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env glycoproteins from clades A, B, and C, respectively.
Group 1 will include healthy adults, ages 18-50 years old who are HIV vaccine-naive. Group 2 will include healthy adults, ages 18-55 years old, who are rollover enrollments from a prior study of the VRC HIV rAd5 vaccine.
Study Group 1 and Group 2 will be simultaneously enrolled. Both groups will be randomized in 1:1 ratio to receive the study injection by needle or Biojector. All study injections will be at a dosage of 10(10) particle units (PU) of rAd5 vaccine delivered into deltoid muscle.
There are more than 100 past study participants who are potentially eligible for Group 2. The study design is based on at least 10 rollover subjects, but allows for additional rollover enrollment of up to 10 more (i.e., Group 2 total n=20) if there is greater than expected interest in participation. The sample for immunogenicity studies collected at Week 4 after vaccination from Group 2 subjects will be obtained by apheresis from those who are willing and eligible for apheresis; otherwise peripheral blood mononuclear cells (PBMCs) will be obtained from 80 mL blood collected by phlebotomy.
Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection and then followed by annual clinic telephone or mail contact for the subsequent 4 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: VRC-HIVADV014-00-VP
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A participant must meet all of the following criteria:
No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study,
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study by one of the following methods:
A volunteer will be excluded if one or more of the following conditions apply:
|Ages||18 Years to 55 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00709605|
|Other Study ID Numbers ICMJE||080171, 08-I-0171|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2012|
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