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About
The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
General and Demographic Criteria
Age of 18 to 49 years.
Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study vaccination.
Agrees not to enroll in another study of an investigational research agent during the study period.
Good general health as shown by medical history, physical exam, and screening laboratory tests without clinically significant findings within the 8 weeks prior to enrollment
Willing to provide nasal, rectal, and cervical (for people born female) mucosal secretion samples and throat, nasal and rectal swab samples (see Appendix J)
HIV-Related Criteria:
Willingness to receive HIV test results and abide by NIH guidelines for partner notification of positive HIV results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
Laboratory Inclusion Values Hemogram/CBC
Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
White blood cell count = 3,300 to 12,000 cells/mm3
Total lymphocyte count ≥ 800 cells/mm3
Remaining differential either within institutional normal range or with site physician approval
Platelets = 125,000 to 550,000/mm3 Chemistry
Chemistry panel: alanine aminotransferase (ALT) < 1.25 times the institutional upper limit of normal and creatinine ≤ institutional upper limits of normal.
Serum total bilirubin ≤ 2 mg/dL Virology
Negative HIV-1 and -2 blood test: Group 1 (A-D) participants must have a negative FDA-approved EIA. Group 2 participants must have a negative test result for HIV infection following the HVTN Lab Program's in-study HIV testing algorithm.
Negative HBsAg
Negative anti-Hepatitis C virus Abs (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Ad4 nAb 80% inhibitory dilution < 1:100 (This criterion does not apply to participants in Group 2).
Urine
Normal urine:
Reproductive Status
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must meet one of the following criteria:
• Agree to consistently use effective contraception (see Appendix B) for sexual activity that could lead to pregnancy at least 21 days prior to enrollment and 28 days following the final vaccination. Effective contraception is defined as using any of the following methods: Condoms (male or female) with or without a spermicide, Diaphragm or cervical cap with spermicide, Intrauterine device (IUD), Hormonal contraception, or Any other contraceptive method approved by the HVTN 110 PSRT Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); or
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Volunteers who were born female and are 21 years of age or older must report having had (or must be willing to undergo prior to enrollment) a Pap smear test. This is not required if the volunteer has had a documented Pap smear within the previous 3 -5 years, depending on the volunteer's age and risk. The Pap smear result must be normal or ASCUS (atypical squamous cells of undetermined significance) (see USPSTF guidelines).
All volunteers must agree to practice abstinence (no intimate contact) for 28 days following each Ad4 vaccination.
Exclusion criteria
General
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age > 45, systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 110 study
Pregnant, breastfeeding, or planning pregnancy before 28 days following the final vaccination
Participant whose intimate contacts do not agree to enroll in the study or consent to be tested for VISP.
Participants who live in the same house or apartment with, have intimate contact with, or care for, any of the following:
Participants caring for children <18 years of age.
Healthcare worker who has direct contact with immunodeficient, unstable, or pediatric patients.
Inability to swallow 11 capsules at a clinic visit Vaccines and other Injections
HIV vaccine(s) received in a prior HIV vaccine trial. (Not applicable to Group 2 participants.) For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 110 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 110 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 110 PSRT on a case-by-case basis.
Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 30 days after the administration of the Ad4-HIV vaccine (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever).
Prior receipt of an Ad5-based vaccine based on self-report
Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 30 days after first vaccination.
Immune System
Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.
Serious adverse reactions to vaccines or to vaccine components such as a history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
History of hypogammaglobulinemia
Autoimmune disease, including history of Guillain-Barre syndrome
Immunodeficiency Clinically significant medical conditions
Untreated or incompletely treated syphilis infection
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to receipt of live virus vaccine, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with past or present psychoses within the past 3 years, past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Chronic respiratory disorders including asthma (see below), emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, defer immunization but do not exclude the participant.
Asthma exclusion criteria:
Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report).
Exclude a volunteer who:
Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids; Needed emergency care, urgent care, hospitalization, or intubation for asthma.
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months
History of radiation therapy or cytotoxic/cancer therapy
Hypertension:
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure. or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
A rectal condition that in the opinion of the clinician represents a contraindication to rectal secretion sampling, such as an active infection or inflammation of the colorectal area (such as an HSV-2 outbreak or inflamed hemorrhoids or colitis/diarrhea).
Any active genital tract infection such as genital sores or ulcers, penile discharge, genital warts of the penis, scrotum, labia minora, vagina, or any other symptomatic genital infection that in the opinion of the clinician represents a contraindication to sample collection.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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