Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector
NCT ID: NCT00801697
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
192 participants
INTERVENTIONAL
2009-02-28
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study will last approximately 12 months. Participants will include those who are both rAD5-naive and rAD5-exposed and will be stratified into one of four groups. Each group will consist of two arms, one interventional and one control. Participants in Groups 1, 2, and 3 will be rAD5-naive. Participants in Group 4 will be rAD5-exposed.
Participants in Group 1 will receive an injection of rAD35 vaccine or placebo at study entry and an injection of rAD5 vaccine or placebo at Month 6 with nine follow-up visits through Month 12. Participants in Groups 2, 3, and 4 will injections of DNA vaccinations or placebo at study entry and at Months 1 and 2, and an injection of rAD35 vaccine, rAD5 vaccine, or placebo at Month 6 with twelve follow-up visits though Month 12. A physical, questionnaire, and counseling will occur at all visits. Blood and urine collection will occur at most visits. A rectal swab will occur at selected visits. For females, a pregnancy test will occur at all visits.
Participants will be contacted for safety follow-ups after the injection every year for 5 years. Health and adverse events will be recorded. Participants will not need to return to the study clinic unless HIV confirmatory testing is needed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1A
rAD5-naive participants will receive rAd35 intramuscularly at study entry and rAd5 intramuscularly at Month 6
rAd35
VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL
rAd5
4 mg VRC-HIVADV038-00-VP administered as 1 mL
1B
Participants will receive rAd35 placebo intramuscularly at study entry and rAd5 placebo intramuscularly at Month 6
rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
rAd5 placebo
1 mL VRC-DILUENT013-DIL-VP
2A
rAD5-naive participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd5 intramuscularly at Month 6
DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
rAd5
4 mg VRC-HIVADV038-00-VP administered as 1 mL
2B
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd5 placebo intramuscularly at Month 6
DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
rAd5 placebo
1 mL VRC-DILUENT013-DIL-VP
3A
Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6
DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
rAd35
VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL
3B
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6
DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
4A
Participants will receive DNA vaccine intramuscularly at study entry and Months 1 and 2 and rAd35 intramuscularly at Month 6
DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
rAd35
VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL
4B
Participants will receive DNA vaccine placebo intramuscularly at study entry and Months 1 and 2 and rAd35 placebo intramuscularly at Month 6
DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DNA Vaccine
4 mg VRC-HIVDNA044-00-VP administered as 1 mL
DNA Vaccine placebo
1 mL VRC-PBSPLA043-00-VP
rAd35
VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL
rAd35 placebo
1 mL VRC-PBSPLA043-00-0VP
rAd5
4 mg VRC-HIVADV038-00-VP administered as 1 mL
rAd5 placebo
1 mL VRC-DILUENT013-DIL-VP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Access to a participating HVTN clinical research site and willingness to be followed for the duration of the study
* Assessment of understanding, including understanding of Step Study results
* Willing to receive HIV test results
* Willing to discuss HIV infection risks, agree to HIV risk reduction counseling, and willing to continue 5 years of annual follow-up contact
* Willing to commit to maintaining behavior consistent with low risk of HIV exposure through the last required protocol visit
* Considered low risk for HIV infection after clinical staff assessment. More information on this criterion can be found in the protocol.
* Certain laboratory values. More information on this criterion can be found in the protocol.
* Negative Hepatitis B surface antigen
* Negative anti-Hepatitis C virus antibodies
* For females, agree to use effective contraception from at least 21 days prior to enrollment through the last protocol visit. More information on this criterion can be found in the protocol.
Exclusion Criteria
* Active drug or alcohol abuse within 12 months prior to study entry
* History of newly acquired sexually transmitted infections. More information on this criterion can be found in the protocol.
* Experimental vaccines received within 5 years prior to study entry
* Immunosuppressive medications received within 168 days prior to first vaccination
* Blood products received within 120 days prior to first vaccination
* Immunoglobulin received within 60 days prior to first vaccination
* Live attenuated vaccines received within 30 days prior to first vaccination
* Investigational research agents received within 30 days prior to first vaccination
* Intent to participate in another study of an investigational research agent during planned duration of the study
* Any vaccines that not live attenuated vaccines and were received within 14 days prior to first vaccination
* Allergy treatment with antigen injections within 30 days prior to first vaccination or scheduled within 14 days after first vaccination
* Clinically significant medical condition, findings, results, or history with implications for current health. More information on this criterion can be found in the protocol.
* Serious adverse reactions to vaccines
* Autoimmune disease
* Immunodeficiency
* Active Syphilis infection within the past 6 months
* Asthma. More information on this criterion can be found in the protocol.
* Diabetes mellitus
* Thyroidectomy or thyroid disease requiring medication during the last 12 months
* Hypertension. More information on this criterion can be found in the protocol.
* Body mass index greater than 35 or 40. More information on this criterion can be found in the protocol.
* Bleeding disorder
* Malignancy
* Seizure disorder
* Asplenia
* Psychiatric condition that precludes compliance with the protocol
* Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the study
* Pregnant or breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HIV Vaccine Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Fuchs, MD, MPH
Role: STUDY_CHAIR
SFDPH/UCSF
Pierre-Alexandre Bart, MD
Role: STUDY_CHAIR
CHUV (Lausanne)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama CRS
Birmingham, Alabama, United States
Bridge HIV CRS
San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health (FH) CRS
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13.
Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.
Sheets RL, Stein J, Bailer RT, Koup RA, Andrews C, Nason M, He B, Koo E, Trotter H, Duffy C, Manetz TS, Gomez P. Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, or Marburg are similar despite differing adenovirus serotype vector, manufacturer's construct, or gene inserts. J Immunotoxicol. 2008 Jul;5(3):315-35. doi: 10.1080/15376510802312464.
Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10702
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 077
Identifier Type: -
Identifier Source: org_study_id