Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults
NCT ID: NCT00123968
Last Updated: 2021-11-09
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/PHASE2
326 participants
INTERVENTIONAL
2006-05-31
2012-06-30
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 comprise two parts, 1 and 2. Part 1 will enroll 144 participants who will be randomly assigned to one of four different groups:
* Group 1A participants will receive a low dose of the adenovirus-vectored HIV vaccine or placebo at study entry.
* Group 1B participants will receive a higher dose of the adenovirus-vectored HIV vaccine or placebo at study entry.
* Group 1C will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
* Group 1D will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a higher dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
Enrollment into Part 2 (Groups 2A and 2B) will begin after the completion of the safety data evaluation of Groups 3 and 4 and after Part A has been fully enrolled. Group 2A participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
There will be 11 study visits over 14 to 16 months for Parts 1 and 2. All study visits will include a physical exam, medical and medication history, vital signs measurement, lymph node assessment, HIV and pregnancy counseling, and blood and urine collection. A home visit will also occur at study entry. A 3-day diary card to report side effects will be completed by participants at study entry and on Days 28, 56, 168, and 210.
There will be 14 study visits for Groups 3, 4, and 5; these visits will include the same tests and assessments as for Groups 1 and 2.
As per an amendment (dated December 19, 2005), follow-up for this study will be extended. The purpose for this extension is to examine in greater depth the efficacy of the vaccine. Specifically, investigators will be exploring whether there is a persistent immune response in participants who received the vaccine as well as if new or boosted responses to the adenovirus vaccine are persistent. The extended follow-up will last for 2 years with clinic visits every 4 months. During visits blood will be drawn for laboratory tests, including HIV testing. Participants will also be informed of ways to reduce their risk of contracting HIV. Two weeks after each visit, participants will be asked to come to the study site for a short post HIV test counseling visit. There will be a total of 6 visits per year, 3 follow-up visits, and 3 post HIV test counseling visits. There will be no more vaccinations.
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.
1A
Participants will receive a low dose of the adenovirus-vectored HIV vaccine or placebo at study entry
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
1B
Participants will receive a higher dose of the adenovirus-vectored HIV vaccine or placebo at study entry
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
1C
Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a low dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP
4 mg administered intramuscularly via injection
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP placebo
4 mg administered intramuscularly via injection
1D
Participants will receive the DNA plasmid vaccine or placebo at study entry and Days 28 and 56. They will also receive either a higher dose of the adenovirus-vectored HIV vaccine or placebo at Day 168.
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP
4 mg administered intramuscularly via injection
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP placebo
4 mg administered intramuscularly via injection
2A
Participants will receive the DNA plasmid vaccine at study entry and Days 28 and 56. They will also receive a low dose of the adenovirus-vectored HIV vaccine at Day 168.
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP
4 mg administered intramuscularly via injection
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
2B
Participants will receive the DNA plasmid vaccine placebo at study entry and Days 28 and 56. They will also receive a the adenovirus-vectored HIV vaccine placebo at Day 168.
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP placebo
4 mg administered intramuscularly via injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VRC-HIVDNA016-00-VP
1x10\^11 per unit vaccine administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP
4 mg administered intramuscularly via injection
VRC-DILUENT013-DIL-VP
Administered intramuscularly via Bioinjector
VRC-HIVADV014-00-VP placebo
4 mg administered intramuscularly via injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing to follow all the requirements of the study and available for follow-up for the duration of the study (14 to 16 months)
* Able and willing to provide informed consent
* Willing to undergo HIV testing and counseling and willing to receive HIV test results
* Willing to not engage in high-risk behavior for HIV infection during the study
* Willing to provide location and be visited at home
* Willing to be identified with picture identification for study purposes
* Willing to use acceptable forms of contraception
* Pregnant women and those with conditions which render phlebotomy volumes hazardous will be allowed to participate using a minimized phlebotomy schedule
Exclusion Criteria
* HIV vaccines in prior HIV vaccine trial
* Immunosuppressive or cytotoxic medications within the 6 months prior to study entry. Participants who have used corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for acute uncomplicated dermatitis are not excluded.
* Blood products within 120 days prior to study entry
* Immunoglobulin within 60 days prior to study entry
* Live attenuated vaccines within 30 days prior to first study vaccine administration
* Medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days prior to first study vaccine administration
* Investigational research agents within 30 days prior to first study vaccine administration
* Current tuberculosis prophylaxis or therapy
* Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
* Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Autoimmune disease or immunodeficiency
* Unstable asthma or asthma requiring emergent or urgent care, hospitalization, intubation, or oral or intravenous corticosteroids during the 2 years prior to study entry
* Diabetes mellitus type 1 or 2. Patients with gestational diabetes are not excluded.
* Thyroid disease, including removal of thyroid or disease requiring medication within 3 years prior to study entry
* Serious angioedema within 3 years prior to study entry or disease requiring medication within 2 years prior to study entry
* Uncontrolled hypertension
* Bleeding disorder
* Active syphilis
* Active cancer OR treated cancer that may recur during the duration of the study
* Seizure disorder. Participants who have had fever-related seizures prior to age 2 are not excluded.
* Absence of spleen OR partial or complete lack of splenic function
* Psychiatric condition that may interfere with the study, including past or present psychoses, bipolar disorder, or suicidal attempts
* Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
* Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
* Pregnancy, breastfeeding, or plan to become pregnant
* Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
* Incapacitating illness precluding clinic visits
* Unable to provide informed consent
* Prisoners will not be enrolled while incarcerated and if enrolled prior to incarceration, will not be followed while in confinement. Re-consent will not be required upon release from prison.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
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.
Merlin Robb, MD
Role: STUDY_CHAIR
US Military HIV Research Program
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho
Kericho, , Kenya
National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) CRS
Mbeya, , Tanzania
Makerere University Walter Reed Project (MUWRP)
Kampala, , Uganda
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.
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
Kibuuka H, Kimutai R, Maboko L, Sawe F, Schunk MS, Kroidl A, Shaffer D, Eller LA, Kibaya R, Eller MA, Schindler KB, Schuetz A, Millard M, Kroll J, Dally L, Hoelscher M, Bailer R, Cox JH, Marovich M, Birx DL, Graham BS, Michael NL, de Souza MS, Robb ML. A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172). J Infect Dis. 2010 Feb 15;201(4):600-7. doi: 10.1086/650299.
Kibuuka H, Guwatudde D, Kimutai R, Maganga L, Maboko L, Watyema C, Sawe F, Shaffer D, Matsiko D, Millard M, Michael N, Wabwire-Mangen F, Robb M. Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa. PLoS One. 2009;4(4):e5164. doi: 10.1371/journal.pone.0005164. Epub 2009 Apr 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10381
Identifier Type: REGISTRY
Identifier Source: secondary_id
RV 172
Identifier Type: -
Identifier Source: org_study_id