Status and phase
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Treatments
About
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-uninfected adults
Full description
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant in repeated doses in healthy, HIV-uninfected adults.
Participants will be enrolled in either Group 1 or 2 with Group 1 being enrolled first to compensate for the longer duration of vaccination period. Within each group, participants will be randomly assigned to either Treatment or Control.
Participants in Group 1 (Treatment) will receive polyvalent env (A,B,C,A/E)/gag (C) DNA vaccine in one arm and polyvalent gp120 (A,B,C,A/E) protein vaccine mixed with GLA-SE adjuvant in the other arm on Day 0 and at Months 3, 6, and 12. Participants in Group 1 (Control) will receive placebo on Day 0 and at Months 3, 6, and 12.
Participants in Group 2 (Treatment) will receive a mixture of polyvalent env (A,B,C,A/E)/gag (C) DNA vaccine and polyvalent gp120 (A,B,C,A/E) protein vaccine (without GLA-SE adjuvant) divided into two doses and administered into each arm on Day 0 and at Months 1, 3, 6, and 8. Participants in Group 2 (Control) will receive placebo on Day 0 and at Months 1, 3, 6, and 8.
Study visits for participants in Group 1 will occur on Day 0, Week 2, Months 3, 3.5, 6, 6.5, 12, 12 + 1 Week, 12.5, 18, and 24. Study visits for participants in Group 2 will occur on Day 0, Week 2, Months 1, 1.5, 3, 3.5, 6, 6.5, 8, 8 + 1 Week, 8.5, 14, and 20. Visits may include physical examination, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age of 18 to 50 years
Access to BWH trial site 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
Agrees not to enroll in another study of an investigational research agent
Good general health as shown by medical history, physical exam, and screening laboratory tests
Willingness to receive HIV test 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. HVTN low risk guidelines will be used.
Laboratory Inclusion Values Hemogram/CBC
Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 12.0 g/dL for volunteers who were born male
White blood cell count = 3,000 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 450,000/mm3 Chemistry
Chemistry panel: ALT, AST, and alkaline phosphatase < 1.25 times the institutional upper limit of normal; creatinine < 1.1 times the institutional upper limit of normal.
Virology
Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA).
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 is positive
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:
Agree to consistently use effective contraception (see Appendix A and Appendix B) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until after the last required protocol clinic visit. Effective contraception is defined as using the following methods:
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
Or be sexually abstinent.
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
Exclusion criteria
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 or any other study that requires non-HVTN HIV antibody testing
Pregnant or breastfeeding
Active duty and reserve US military personnel Vaccines and other Injections
HIV vaccine(s) received in a prior HIV vaccine trial.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial, unless the vaccine subsequently received regulatory approval or emergency authorization.
Live attenuated vaccines, other than influenza vaccine, received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
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 14 days after first vaccination Immune System
Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical immunosuppressives; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 60 mg/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 including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease, connective tissue disease, or history of vasculitis, eg, leukocytoclastic vasculitis, Henoch-Schonlein Purpura
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, 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 psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Asthma exclusion criteria:
Asthma other than mild, well-controlled asthma.
Exclude a volunteer who:
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
Hypertension:
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded from participation: 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.
Primary purpose
Allocation
Interventional model
Masking
42 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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