Status:
COMPLETED
Safety of and Immune Response to a DNA HIV Vaccine (pGA2/JS7) Boosted With a Modified Vaccinia HIV Vaccine (MVA/HIV62) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
HIV Vaccine Trials Network
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, easily produced in large quantit...
Eligibility Criteria
Inclusion
- HIV uninfected
- Has access to a participating HIV Vaccine Trials Unit (HVTU) and is willing to be followed for the duration of the study
- Understands vaccination procedure
- Willing to receive HIV test results
- Good general health
- Willing to use acceptable forms of contraception
Exclusion
- Received HIV vaccines in prior HIV vaccine trial
- Received vaccinia vaccine. More information on this criterion can be found in the protocol.
- Recreational cocaine or methamphetamine use within 12 months prior to study entry
- Immunosuppressive medications within 168 days prior to first study vaccine administration. Participants who use corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Subunit or killed vaccines within 14 days (for influenza or pneumococcal vaccines) or 30 days (for allergy treatment with antigen injections) prior to first study vaccine administration
- Current tuberculosis prophylaxis or therapy
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
- 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
- Allergy to egg products
- Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- History of or known active cardiac disease. More information on this criterion can be found in the protocol.
- Electrocardiogram (ECG) with clinically significant findings OR features that would interfere with assessments for myocarditis or pericarditis. More information on this criterion can be found in the protocol.
- Two or more of the following cardiac risk factors: elevated blood cholesterol (defined as fasting low density lipoprotein \[LDL\] of greater than 160 mg/dl); first-degree relative (e.g., mother, father, brother, sister) who had coronary artery disease before the age of 50; current smoker; or body mass index (BMI) greater than 35
- Autoimmune disease or immunodeficiency
- Active syphilis infection. Participants whose syphilis infection was fully treated at least 6 months prior to study entry are not excluded.
- Severe and unstable asthma
- Diabetes mellitus type 1 or 2
- Thyroid disease requiring treatment
- Serious angioedema within the past 2 years
- Uncontrolled hypertension OR systolic blood pressure (BP) of 150 mmHg or greater or diastolic BP of 100 mmHg or greater
- BMI greater than 40
- Bleeding disorder
- Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.
- Seizure disorder
- Asplenia
- Mental illness that would interfere with compliance with the protocol
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnancy or breastfeeding, or plans to become pregnant
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00301184
Start Date
April 1 2006
End Date
December 1 2008
Last Update
August 8 2022
Active Locations (6)
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1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294-2041
2
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
3
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115
4
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, United States, 63110-2500