HIV Infections Clinical Trial
Official title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Regimens Utilizing Recombinant Adenovirus Serotype 35 (rAd35) With HIV-1 Clade A Env Insert and Recombinant Adenovirus Serotype 5 (rAd5) With HIV-1 Clade A or B Env Inserts in Healthy, HIV-1-Uninfected Adults
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV-1 vaccine regimen that includes two vaccines given at different time points in HIV-uninfected adults.
Status | Completed |
Enrollment | 180 |
Est. completion date | February 2016 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Assessed by clinic staff as being "low risk" for HIV infection - Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willing to be followed for the duration of the study - Able and willing to provide informed consent - Assessment of understanding, including the completion of a questionnaire before the first vaccination and demonstration of understanding for all questionnaire items answered incorrectly - Willing to receive HIV test results - Willing to discuss HIV infection risks, amenable to HIV risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required study visit - Willing to continue annual follow-up contact after the final study visit for a total of 5 years after study entry - In good general health, as shown by medical history, physical exam, and screening laboratory tests - Assessed by the clinic staff as having a low risk of HIV infection on the basis of sexual behaviors in the 12 months before study entry. More information on this criterion can be found in the protocol. - Adenovirus 5 nAb titer less than 1:18 - Adenovirus 35 nAb titer less than 1:12 - Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female and greater than or equal to 13.0 g/dL for participants who were born male - White blood cell (WBC) count between 3,300 to 12,000 cells/mm^3 - Total lymphocyte count greater than or equal to 800 cells/mm^3 - Remaining differential either within site's normal range or with site physician approval - Platelet level between 125,000 to 550,000/mm^3 - Alanine aminotransferase (ALT) less than or equal to 1.25 times the site's upper limit of normal - Negative HIV-1 and -2 blood test - Negative Hepatitis B surface antigen (HBsAg) - Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV test is positive - Normal urine test results - Participants who were born female must have a negative pregnancy test result before the first study vaccination - Participants who were born female must agree to use an effective form of contraception from at least 21 days before study entry until the last study visit. More information on this criterion can be found in the protocol. - Participants who were born female must agree not to seek pregnancy through alternative methods (e.g., artificial insemination, in vitro fertilization) until after the last study visit - If born male, must be fully circumcised (as documented at screening examination) Exclusion Criteria: - Excessive daily alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs in the 12 months before study entry - History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B in the 12 months before study entry - Received non-HIV experimental vaccines in a previous vaccine trial in the 5 years before study entry - Received HIV vaccines in a prior HIV vaccine trial - Immunosuppressive medications received within 168 days before the first study vaccination - Blood products received within 120 days before the first study vaccination - Immunoglobulin received within 60 days before the first study vaccination - Live attenuated vaccines received within 30 days before the first study vaccination or scheduled within 14 days after injection - Investigational research agents received within 30 days before the first study vaccination - Intent to participate in another investigational drug study - Any vaccines that are not live attenuated vaccines and were received within 14 days before the first study vaccination - Allergy treatment with antigen injections within 30 days before the first study vaccination or scheduled within 14 days after the first vaccination - Current anti-tuberculosis (TB) prophylaxis or therapy - Clinically significant medical condition, abnormal physical examination findings, clinically significant abnormal laboratory results, or past medical history that may affect current health - Any medical, psychiatric, occupational, or other condition that would interfere with participation in the study - Serious adverse reactions to vaccines, including anaphylaxis and related symptoms (e.g., hives, respiratory difficulty, angioedema, abdominal pain). A person who had an adverse reaction to the pertussis vaccine is not excluded. - Autoimmune disease or immunodeficiency - Active syphilis infection - Asthma, other than mild well-controlled asthma. More information on this criterion can be found in the protocol. - Type 1 or type 2 diabetes mellitus, including cases controlled with diet alone. People with a history of gestational diabetes are not excluded. - Surgical removal of the thyroid or thyroid disease requiring medication in the 12 months before study entry - Angioedema in the 3 years before study entry or angioedema requiring medication in the 2 years before study entry - High blood pressure that is not well controlled or high blood pressure of 150/100 mm Hg or greater at study entry. More information on this criterion can be found in the protocol. - Body mass index (BMI) greater than or equal to 40, or BMI greater than or equal to 35 and two or more of the following conditions: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, or known hyperlipidemia - Bleeding disorder (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions) - Cancer. People with surgically removed cancer, that in the opinion of the investigator, is unlikely to recur during the study period are not excluded. - Seizure disorder. People with a history of seizures who have not required medications or had a seizure within the 3 years before study entry are not excluded. - Absence of the spleen - Psychiatric condition that makes study compliance difficult (e.g., people with psychoses in the 3 years before study entry, ongoing risk for suicide, history of suicide attempt in the 3 years before study entry) - Pregnant or breastfeeding - Has been circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed |
Country | Name | City | State |
---|---|---|---|
United States | Alabama CRS | Birmingham | Alabama |
United States | Brigham and Women's Hospital Vaccine CRS (BWH VCRS) | Boston | Massachusetts |
United States | The Hope Clinic of the Emory Vaccine Center CRS | Decatur | Georgia |
United States | Vanderbilt Vaccine (VV) CRS | Nashville | Tennessee |
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 | Bridge HIV CRS | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Appay V, Douek DC, Price DA. CD8+ T cell efficacy in vaccination and disease. Nat Med. 2008 Jun;14(6):623-8. doi: 10.1038/nm.f.1774. Review. — View Citation
Vaine M, Lu S, Wang S. Progress on the induction of neutralizing antibodies against HIV type 1 (HIV-1). BioDrugs. 2009;23(3):137-53. doi: 10.2165/00063030-200923030-00001. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of local injection site reactogenicity signs and symptoms, including pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness | Measured at baseline and Month 3 | ||
Primary | Frequency and severity of systemic reactogenicity signs and symptoms, including fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms | Measured at baseline and Month 3 | ||
Primary | Frequency of adverse events (AEs) categorized by MedDRA body system, MedDRA preferred term, severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting | Measured at Month 9 | ||
Primary | Distribution of values of safety laboratory measures, including white blood cells (WBCs), neutrophils, lymphocytes, hemoglobin, platelets, and alanine aminotransferase (ALT) at baseline and at postvaccination follow-up study visits | Measured at Month 9 | ||
Primary | Number of participants with early discontinuation of vaccinations and reason for discontinuation | Measured at Month 9 | ||
Primary | Number of shared HIV epitopes targeted by T-cells | Measured at 4 weeks following the final vaccination | ||
Primary | HIV-1-specific interferon gamma (IFN-y) ELISpot responses | Measured at 4 weeks following the final vaccination | ||
Secondary | Number of shared HIV epitopes targeted by T-cells | Measured at 4 weeks following the final vaccination | ||
Secondary | HIV-1-specific IFN-y ELISpot responses | Measured at 4 weeks following the final vaccination | ||
Secondary | Frequency of insert-specific CD4 and CD8 cells | Measured at 4 weeks following the final vaccination | ||
Secondary | Number of HIV epitopes targeted by T-cells | Measured at 4 weeks following the final vaccination | ||
Secondary | Functional spectrum of CD4 and CD8 cells by intracellular cytokine staining (ICS) assay for IFN-y, IL-2, and TNF-a | Measured at Month 9 | ||
Secondary | Binding and neutralizing antibody titers | Measured at baseline and at 4 weeks following the final vaccination |
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