Safety of and Immune Response to Two HIV Vaccines: SAAVI DNA-C2 Boosted With SAAVIMVA-C, in HIV-Negative Adults
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: December 13, 2007
Last updated: June 1, 2016
Last Verified: June 2016
History of Changes
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.
Biological : SAAVI DNA-C2 vaccine
Biological : SAAVI MVA-C vaccine
Biological : Placebo
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase 1 Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of SAAVI DNA-C2 Vaccine Boosted by SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Vaccinia Naive Adult Participants in South Africa and the United States|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures
- Signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, and adverse events [ Time Frame: Measured throughout study ]
- T-cell responses as detected by HIV-1 specific interferon-gamma/interleukin-2 intracellular cytokine staining [ Time Frame: Measured 2 weeks following the fourth and fifth vaccinations ]
- HIV-1-specific neutralizing and binding antibody assays [ Time Frame: Measured 2 weeks following the fourth and fifth vaccinations ]
|Study Start Date:||November 2008|
|Study Completion Date:||January 2013|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
SAAVI DNA-C2 administered as 1 ml intramuscularly in either deltoid at study entry and Months 1 and 2; SAAVI MVA-C administered as 0.5 ml intramuscularly in either deltoid at Months 4 and 5
SAAVI DNA-C2 vaccine
Biological: SAAVI MVA-C vaccine
Placebo administered at Months 0, 1, 2, 4 and 5
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of
a safe and effective vaccine that will prevent HIV infection. Due to the high prevalence of
HIV-1 subtype C in southern Africa, the South African AIDS Vaccine Initiative (SAAVI), the
HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious
Diseases (NIAID) are evaluating two subtype C HIV vaccines, SAAVI DNA-C2 and SAAVI MVA-C
through this study . These two vaccines will be used together in a prime-boost regimen. The
SAAVI DNA-C2 vaccine is a multigene DNA vaccine consisting of two DNA plasmids in equal
amounts that express an HIV-1 subtype C polyprotein comprising of Gag-Reverse
Transcriptase-Tat-Nef and an HIV-1 subtype C truncated Env. SAAVI MVA-C is a recombinant MVA
vaccine expressing the same immunogens as the SAAVI DNA-C2 vaccine. MVA is a highly
attenuated vaccinia virus. The purpose of this study is to evaluate the safety and
immunogenicity of an experimental DNA HIV vaccine, SAAVI DNA C2, followed by boosting with an
experimental recombinant MVA HIV vaccine, SAAVI MVA-C, in HIV uninfected adults.
Participants will actively participate in this study for 12 months and will then be contacted and asked questions about their health once annually for 3 years following initial study injection. Participants will be randomly assigned to receive either the SAAVI prime-boost preventive vaccine regimen or placebo. Vaccination with the SAAVI DNA-C2 vaccine will occur at Months 0, 1, and 2; boost vaccinations with the SAAVI MVA-C vaccine will occur at Months 4 and 5. Additional study visits will occur at Weeks 2, 6, 10, 16, 18, and 20 and Days 147, 154, 273, and 364.
Study procedures include physical exams, blood and urine collection, HIV testing, an electrocardiogram, and questionnaire. Some blood collected from participants will be stored and used in future research. Risk-reduction counseling will be conducted at all study visits.
|Ages Eligible for Study:||18 Years to 45 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
- Hypertension that is not well-controlled
- Body mass index (BMI) of 40 or more
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder requiring medication within the last 3 years
- Absence of spleen
- Certain abnormal laboratory values
- Psychiatric condition that would interfere with compliance with the protocol
- Other conditions that, in the opinion of the investigator, would interfere with the study
- Pregnancy or breastfeeding
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574600
Locations Show More
|United States, Massachusetts|
|Brigham and Women's Hospital Vaccine CRS (BWH VCRS)|
|Boston, Massachusetts, United States, 02115-6110|
|Fenway Health (FH) CRS|
|Boston, Massachusetts, United States, 02215-4302|
|Soweto HVTN CRS|
|Johannesburg, Gauteng, South Africa, 1862|
|Cape Town, Western Cape Province, South Africa, 7750|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
|Study Chair:||Glenda Gray||University of the Witswatersrand|
|Study Chair:||Kenneth Mayer||Fenway Community Health|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00574600 History of Changes|
|Other Study ID Numbers:||HVTN 073/SAAVI 102|
|Study First Received:||December 13, 2007|
|Last Updated:||June 1, 2016|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):HIV Seronegativity
HIV Preventive Vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 23, 2019
This information is provided by ClinicalTrials.gov.