Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2015-11-30
2018-07-31
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.
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
300 ug FLSC vaccine
Subjects will be vaccinated with 300 ug FLSC vaccine (highest vaccine dose) on study days 0, 28, 56 and 168.
300 ug FLSC vaccine
FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
150 ug FLSC vaccine
Subjects will be vaccinated with 150 ug FLSC vaccine (middle vaccine dose) on study days 0, 28, 56 and 168.
150 ug FLSC vaccine
FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
75 ug FLSC vaccine
Subjects will be vaccinated with 75 ug FLSC vaccine (lowest vaccine dose) on study days 0, 28, 56 and 168.
75 ug FLSC vaccine
FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Placebo
Subjects will be vaccinated with placebo (control group) on study days 0, 28, 56 and 168.
Placebo
Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
300 ug FLSC vaccine
FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
150 ug FLSC vaccine
FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
75 ug FLSC vaccine
FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Placebo
Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
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
2. Sex: Male or Female (female volunteers of child bearing potential must have a negative serum beta human chorionic gonadotropin (b-HCG or pregnancy) test at time of screening and entry into the study and provide assurance of the use of effective(as judged by the investigator) birth control methods or abstinence beginning at least 60 days prior to the study and during the study
3. Documented HIV-1 negative by ELISA
Exclusion Criteria
6. Negative b-HCG pregnancy test on the day of initial vaccination.
7. Negative screen for Hepatitis B surface antigen (HBsAg);
8. Negative screen for antibodies to Hepatitis C virus (Patient may enroll if patient can provide documentation of negative hepatitis C viral load.)
9. Participant must have a CD4 count ( a type of white blood cells) within the normal range of the clinical laboratory utilized for the study and a CD4 percentage within 20% of the normal range of the clinical laboratory
11. Volunteers must be willing and able to provide written informed consent to participate in the study.
12. Available for at least 48 weeks of follow-up.
1. High risk behavior for acquisition of HIV within 24 weeks of study entry(i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
2. Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
3. Have active tuberculosis or other systemic infectious process by review of systems and physical examination
4. Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
5. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
6. Is pregnant
7. History of any chronic illness that would interfere with conduct or completion of study(as determined by the investigator)
8. Have evidence of psychiatric, medical and/or substance abuse problems during the past 24 weeks that the investigator believes would adversely affect the volunteer's ability to participate in the trial
9. Have occupational or other responsibilities that would prevent completion of participation in the study
10. Have received any live, attenuated vaccine except rabies vaccine within 60 days of study entry
11. Vaccine (FDA approved; e.g. influenza, pneumovax, etc) administration within 30 days of immunization with the study vaccine. NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) should be given prior to trial initiation or after completion of the study immunizations. If patient requires immunization, injections should be given more than 2 weeks prior or 2 weeks after study immunization
12. Have used experimental therapeutic agents within 30 days of study entry
13. Have received blood products or immunoglobulins in the past 12 weeks
14. Have a history of anaphylaxis or other serious adverse reactions to vaccines
15. Have previously received an HIV vaccine
16. Volunteers with any of the following laboratory parameters at the screening visit (within 30 days of immunization): Hemoglobin \<10 (without having received a blood or red blood cell transfusion within 30 days prior to laboratory test); neutrophil count \<750 cells/mm3; platelet count \<50,000/mm3; serum creatinine \> 2.0 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limits of normal; total bilirubin \> 1.5 mg/dL
17. Pregnant women or women who are breast-feeding; female volunteers of childbearing potential who are not using or willing to use an effective (as judged by the investigator) barrier contraceptive methods or abstinence while enrolled in this study.
18. Use of any immune modulators or suppressors within 45 days of study entry including but not limited to agents such as interleukins (e.g. IL-2), interferons (e.g. IFN-\*), high dose systemic steroids (e.g. ≥ 20 mg prednisone equivalent/day) for \> 30 days, thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF), dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleoside, ditiocarb sodium, cyclosporin, mycophenolate mofetil, methotrexate, and cancer chemotherapy.
19. No other investigational agent within 30 days of study entry
20. Any other condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results
21. Have active Hepatitis B virus infection (positive HBsAg) or Hepatitis C infection(defined as positive antibodies)
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bill and Melinda Gates Foundation
OTHER
Auro Vaccines LLC
INDUSTRY
University of Maryland, Baltimore
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammad Sajadi
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles E Davis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Institute of Human Virology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HP-00065547
Identifier Type: -
Identifier Source: org_study_id