Safety of and Immune Response to Two HIV Vaccines: SAAVI DNA-C2 Boosted With SAAVIMVA-C, in HIV-Negative Adults
NCT ID: NCT00574600
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2008-11-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Vaccine
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
DNA vaccine
SAAVI MVA-C vaccine
Boost vaccine
Placebo
Placebo administered at Months 0, 1, 2, 4 and 5
Placebo
Placebo vaccine
Interventions
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SAAVI DNA-C2 vaccine
DNA vaccine
SAAVI MVA-C vaccine
Boost vaccine
Placebo
Placebo vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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HIV Vaccine Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Glenda Gray
Role: STUDY_CHAIR
University of the Witswatersrand
Kenneth Mayer
Role: STUDY_CHAIR
Fenway Community Health
Locations
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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
Countries
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References
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Hanke T, McMichael AJ, Dorrell L. Clinical experience with plasmid DNA- and modified vaccinia virus Ankara-vectored human immunodeficiency virus type 1 clade A vaccine focusing on T-cell induction. J Gen Virol. 2007 Jan;88(Pt 1):1-12. doi: 10.1099/vir.0.82493-0.
Verrier F, Burda S, Belshe R, Duliege AM, Excler JL, Klein M, Zolla-Pazner S. A human immunodeficiency virus prime-boost immunization regimen in humans induces antibodies that show interclade cross-reactivity and neutralize several X4-, R5-, and dualtropic clade B and C primary isolates. J Virol. 2000 Nov;74(21):10025-33. doi: 10.1128/jvi.74.21.10025-10033.2000.
Williamson C, Morris L, Maughan MF, Ping LH, Dryga SA, Thomas R, Reap EA, Cilliers T, van Harmelen J, Pascual A, Ramjee G, Gray G, Johnston R, Karim SA, Swanstrom R. Characterization and selection of HIV-1 subtype C isolates for use in vaccine development. AIDS Res Hum Retroviruses. 2003 Feb;19(2):133-44. doi: 10.1089/088922203762688649.
Gray GE, Mayer KH, Elizaga ML, Bekker LG, Allen M, Morris L, Montefiori D, De Rosa SC, Sato A, Gu N, Tomaras GD, Tucker T, Barnett SW, Mkhize NN, Shen X, Downing K, Williamson C, Pensiero M, Corey L, Williamson AL. Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol. 2016 Jun 6;23(6):496-506. doi: 10.1128/CVI.00717-15. Print 2016 Jun.
Other Identifiers
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10520
Identifier Type: REGISTRY
Identifier Source: secondary_id
SAAVI 102
Identifier Type: -
Identifier Source: secondary_id
HVTN 073
Identifier Type: -
Identifier Source: secondary_id
HVTN 073/SAAVI 102
Identifier Type: -
Identifier Source: org_study_id