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A Phase I Clinical Trial to Evaluate Immune Response Kinetics and Safety of Two Different Primes, Adenoviral Vector Vaccine (VRC-HIVADV014-00-VP) and DNA Vaccine (VRC-HIVDNA009-00-VP), Each Followed by Adenoviral Vector Boost in Healthy, HIV-1 Uninfected Adults


Phase 1
18 Years
50 Years
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Phase I Clinical Trial to Evaluate Immune Response Kinetics and Safety of Two Different Primes, Adenoviral Vector Vaccine (VRC-HIVADV014-00-VP) and DNA Vaccine (VRC-HIVDNA009-00-VP), Each Followed by Adenoviral Vector Boost in Healthy, HIV-1 Uninfected Adults


Evaluating the immunogenicity of HIV vaccines is critical to improving vaccine design and
development. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity
in early studies and appeared safe and well tolerated at three different doses in a prior
dose-escalation vaccine trial in HIV uninfected adults. The DNA HIV vaccine
VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the
DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The DNA plasmids in both
vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of
new HIV infections. This study will determine the safety and immune response to the
administration of an adenoviral vector HIV vaccine or a DNA HIV vaccine, each followed by an
adenoviral vaccine boost, in HIV uninfected adults.

This study will last 1 year. Participants will be randomly assigned to one of two groups.
Within each group, participants will be randomly assigned to receive either vaccine or
control injections. Group 1 participants will receive either placebo or the adenoviral HIV
vaccine at study entry and Month 6. Group 2 participants will receive either placebo or the
DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6.
Participants will be asked to record their temperatures and other side effects in a symptom
log on the day of each vaccination and for 3 days thereafter to report any side effects.

Group 1 participants will have 16 study visits, and a physical exam and HIV and pregnancy
prevention counseling will occur at each visit. Participants will also be asked about any
side effects and medications they are taking. Blood collection will occur at most visits.
Urine collection will occur at selected visits. Participants will be asked to complete a
social impact assessment at Months 2, 6, and 12 and a testing and belief questionnaire at
Months 6 and 12.


Inclusion Criteria:



- HIV uninfected

- Good general health

- Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of less than a 1:12
ratio

- Hepatitis B surface antigen negative

- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV
antibody is positive

- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be
followed during the study

- Willing to receive HIV test results

- Understand the vaccination procedure

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- HIV vaccines or placebos in prior HIV trial. Participants who can provide
documentation that they received a placebo in a prior HIV trial may be eligible.

- Immunosuppressive medications within 168 days prior to first study vaccination

- Blood products within 120 days prior to first study vaccination

- Live attenuated vaccines within 30 days prior to first study vaccination

- Investigational research agents within 30 days prior to first study vaccination

- Medically indicated subunit or killed vaccines within 14 days prior to first study
vaccination

- Current anti-tuberculosis (TB) preventive therapy or treatment

- Clinically significant medical condition, abnormal physical exam findings, abnormal
laboratory results, or past medical history that may affect current health. More
information about this criterion can be found in the protocol.

- Any medical, psychiatric, or social condition that would interfere with the study.
More information about this criterion can be found in the protocol.

- Any job-related responsibility that would interfere with the study

- Serious adverse reactions to vaccines, including hypersensitivity and related
symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not
excluded.

- Autoimmune disease or immunodeficiency

- Active syphilis infection. Participants who have been fully treated for syphilis for
more than 6 months prior to study entry are not excluded.

- Moderate to severe asthma. More information on this criterion can be found in the
protocol.

- Type 1 or type 2 diabetes mellitus. Participants with histories of isolated
gestational diabetes are not excluded.

- Thyroid disease or surgical removal of the thyroid requiring medication during the 12
months prior to study entry

- Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study
entry if episodes are considered serious or have required medication in the 2 years
prior to study entry

- Uncontrolled hypertension

- Body mass index (BMI) of 40 or greater OR BMI of 35 or greater if certain other
criteria apply. More information about these criteria can be found in the protocol.

- Bleeding disorder

- Cancer. Participants with surgically removed cancer that is unlikely to recur are not
excluded.

- Seizure disorder

- Absence of the spleen

- Mental illness that would interfere with the study

- Pregnancy or breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)

Outcome Time Frame:

After each injection and for 6 months after the last injection

Safety Issue:

Yes

Principal Investigator

Stephen De Rosa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center and University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

HVTN 068

NCT ID:

NCT00270218

Start Date:

February 2006

Completion Date:

August 2007

Related Keywords:

  • HIV Infections
  • HIV Seronegativity
  • Adenoviral Vector Vaccine
  • DNA Plasmid Vaccine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Alabama Vaccine CRS Birmingham, Alabama  35294
San Francisco Vaccine and Prevention CRS San Francisco, California  94102
HIV Prevention & Treatment CRS New York, New York  10032
NY Blood Ctr./Union Square CRS New York, New York  10003
Univ. of Rochester HVTN CRS Rochester, New York  14642
Vanderbilt Vaccine CRS Nashville, Tennessee  37232
FHCRC/UW Vaccine CRS Seattle, Washington  98104