Safety of and Immune Response to Two HIV Vaccines: SAAVI DNA-C2 Boosted With SAAVIMVA-C, in HIV-Negative Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA) in HIV uninfected adults.

Key facts

Study ID

NCT00574600

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Starts

2008-11-01

Expected to finish

2013-01-01

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Laboratory test results within specified ranges [complete blood count, chemistries, cardiac troponin T, urinalysis]
• Good general health
• HIV-1 and -2 uninfected
• Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
• Willing to receive HIV test results
• Negative hepatitis B surface antigen
• Negative hepatitis C virus (HCV) antibodies OR negative HCV PCR if anti-HCV test is positive
• Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study

You may not qualify if…

• History of vaccination against smallpox
• HIV vaccines in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first study vaccination
• Blood products within 120 days prior to first study vaccination
• Immunoglobulin within 60 days prior to first study vaccination
• Live attenuated vaccines within 30 days prior to first study vaccination or scheduled within 14 days after other vaccination (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; influenza vaccine in nasal form)
• Investigational research agents within 30 days prior to first study vaccination
• Any vaccines that are not live attenuated vaccines within 14 days prior to first study vaccination
• Allergy treatment with antigen injections within 30 days prior to first vaccination or scheduled within 14 days after vaccination
• Received investigational research agents within 30 days prior to first vaccination
• Current tuberculosis (TB) prophylaxis or therapy
• Recreational cocaine or methamphetamine use within the last 12 months prior to first study vaccination
• 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, social, or job-related condition that would interfere with the study
• Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.
• Hypersensitivity to eggs or egg products
• Electrocardiogram (ECG) with clinically significant findings. More information about this criterion can be found in the protocol.
• Risk factors for heart disease. More information about this criterion can be found in the protocol.
• History of or current heart disease. More information about this criterion can be found in the protocol.
• Autoimmune disease or immunodeficiency
• Active syphilis infection. Participants with fully treated syphilis at least 6 months prior to study entry are not excluded.
• Unstable asthma. More information about this criterion can be found in the protocol.
• Diabetes mellitus type 1 or 2. Participants with a history of isolated gestational diabetes are not excluded.
• History of thyroid removal or of thyroid disease requiring treatment in the 12 months prior to study entry
• Serious angioedema within the past 3 years or requiring medication within 2 years of study entry

Where it is running

• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• Fenway Health (FH) CRS — Boston, Massachusetts, United States
• Soweto HVTN CRS — Johannesburg, Gauteng, South Africa
• Emavundleni CRS — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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