Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults
NCT ID: NCT00618605
Last Updated: 2021-11-01
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
60 participants
INTERVENTIONAL
2008-02-29
2015-10-31
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 12 months. Participants will be randomly assigned to one of four arms that will receive different doses of the vaccine or placebo administered via intermuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Each injection will contain the same dose of vaccine. Arm 4 will receive 2 injections of a dose of vaccine that will be determined by the safety data from Arms 1, 2, and 3. Participants will be enrolled sequentially, from lowest to highest dose of vaccine, into Arms 1, 2, and 3. Arms will begin enrollment only following review of safety data from the previous group. After the Day 42 safety data from Arms 1, 2, and 3 have been reviewed, the dose for Arm 4 will be determined, and enrollment into that arm will begin.
There will be 10 study visits in this study, occurring at baseline and after 0.5, 1, 1.5, 2, 6, 6.5, 7, and 12 months. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. Participants in Arm 4 will receive injections on Days 0 and 168. Participants will be asked to record their temperature and other side effects in a symptom log for 7 days after each injection. Risk reduction/pregnancy prevention counseling will occur at visits 1 through 9, and physical exams and assessments of illness or adverse events will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. At some visits, HIV testing and pregnancy testing will occur.
Once a year for 5 years following study entry, participants will attend a study visit or will be contacted by study staff by telephone or e-mail for follow-up safety and health monitoring. Some participants will also undergo a blood collection at these visits.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
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.
1
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^9 virus particles (VP) given at Days 0, 28, and 168
Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
2
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^10 VP given at Days 0, 28, and 168
Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
3
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10\^11 VP given at Days 0, 28, and 168
Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
4
2 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at a dose to be determined by the safety data from Arms 1, 2 and 3 given at Days 0 and 168
Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Demonstrated understanding of study
* Willing to receive HIV test results
* HIV-1 and -2 uninfected
* Hepatitis B surface antigen negative
* Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
* Appropriate hemoglobin, white blood cell, lymphocyte, and platelet count values as defined in the study protocol
* Certain laboratory values as defined in the study protocol
* Adequate contraception from at least 21 days prior to study entry through visit 10
Exclusion Criteria
* Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
* Blood products within 120 days prior to first injection
* Immunoglobulin within 60 days prior to first injection
* Investigational agents within 30 days prior to first injections
* Live attenuated vaccine within 30 days prior to first injection
* Any vaccine not a live attenuated vaccine within 14 days prior to first injection
* Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
* Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
* Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
* Known autoimmune disease
* Known immunodeficiency
* Asthma other than mild and/or well-controlled asthma
* Active syphilis infection. Those fully treated for syphilis over 6 months prior to study entry are not excluded.
* Diabetes mellitus type 1 or 2
* Thyroidectomy or thyroid disease requiring medication within 12 months prior to study entry
* Angioedema in the 3 years prior to study entry if the episodes are considered serious or have required medication within the last 2 years
* Hypertension. More information on this criterion can be found in the protocol.
* Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
* Bleeding disorder
* Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
* Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
* Absence of a functional spleen
* Psychiatric condition within the last 3 years. More information on this criterion can be found in the study protocol.
* Individuals at high-risk of acquiring HIV infection
* Presence of pre-existing neutralizing antibodies for Adenovirus 26
* Pregnancy or breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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.
Lindsey Baden, MD
Role: STUDY_CHAIR
Brigham and Women's Hospital
Dan Barouch, MD, PhD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Raphael Dolin, MD
Role: STUDY_CHAIR
Brigham and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS
Boston, Massachusetts, 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.
Abbink P, Lemckert AA, Ewald BA, Lynch DM, Denholtz M, Smits S, Holterman L, Damen I, Vogels R, Thorner AR, O'Brien KL, Carville A, Mansfield KG, Goudsmit J, Havenga MJ, Barouch DH. Comparative seroprevalence and immunogenicity of six rare serotype recombinant adenovirus vaccine vectors from subgroups B and D. J Virol. 2007 May;81(9):4654-63. doi: 10.1128/JVI.02696-06. Epub 2007 Feb 28.
Liniger M, Zuniga A, Naim HY. Use of viral vectors for the development of vaccines. Expert Rev Vaccines. 2007 Apr;6(2):255-66. doi: 10.1586/14760584.6.2.255.
Roberts DM, Nanda A, Havenga MJ, Abbink P, Lynch DM, Ewald BA, Liu J, Thorner AR, Swanson PE, Gorgone DA, Lifton MA, Lemckert AA, Holterman L, Chen B, Dilraj A, Carville A, Mansfield KG, Goudsmit J, Barouch DH. Hexon-chimaeric adenovirus serotype 5 vectors circumvent pre-existing anti-vector immunity. Nature. 2006 May 11;441(7090):239-43. doi: 10.1038/nature04721. Epub 2006 Apr 16.
Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, Johnson JA, Kleinjan J, Yanosick KE, Perry J, Zablowsky E, Abbink P, Peter L, Iampietro MJ, Cheung A, Pau MG, Weijtens M, Goudsmit J, Swann E, Wolff M, Loblein H, Dolin R, Barouch DH. First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):240-7. doi: 10.1093/infdis/jis670. Epub 2012 Nov 2.
Barouch DH, Liu J, Peter L, Abbink P, Iampietro MJ, Cheung A, Alter G, Chung A, Dugast AS, Frahm N, McElrath MJ, Wenschuh H, Reimer U, Seaman MS, Pau MG, Weijtens M, Goudsmit J, Walsh SR, Dolin R, Baden LR. Characterization of humoral and cellular immune responses elicited by a recombinant adenovirus serotype 26 HIV-1 Env vaccine in healthy adults (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):248-56. doi: 10.1093/infdis/jis671. Epub 2012 Nov 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10623
Identifier Type: REGISTRY
Identifier Source: secondary_id
Ad26.ENVA.01
Identifier Type: -
Identifier Source: secondary_id
Ad26.ENVA.01/IPCAVD-001
Identifier Type: -
Identifier Source: org_study_id