| Eligibility |
Inclusion Criteria:
1. Age of 18 to 50 years
2. Access to BWH trial site and willingness to be followed for the planned duration of
the study
3. Ability and willingness to provide informed consent
4. 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
5. Agrees not to enroll in another study of an investigational research agent
6. Good general health as shown by medical history, physical exam, and screening
laboratory tests
7. Willingness to receive HIV test results
8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling.
9. 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
10. Hemoglobin = 11.0 g/dL for volunteers who were born female, = 12.0 g/dL for volunteers
who were born male
11. White blood cell count = 3,000 to 12,000 cells/mm3
12. Total lymphocyte count > 800 cells/mm3
13. Remaining differential either within institutional normal range or with site physician
approval
14. Platelets = 125,000 to 450,000/mm3 Chemistry
15. 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
16. Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved
enzyme immunoassay (EIA).
17. Negative Hepatitis B surface antigen (HBsAg)
18. Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase
chain reaction (PCR) if the anti-HCV is positive
- Negative urine glucose, and
- Negative or trace urine protein, and
- Negative, trace, or 1+ urine hemoglobin (if 1+ hemoglobin is present on dipstick,
a microscopic urinalysis with red blood cells levels within institutional normal
range).
Reproductive Status
19. Volunteers who were born female: negative serum or urine beta human chorionic
gonadotropin (ß-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.
20. 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:
- 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 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 post vasectomy);
- 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.
21. 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:
1. Blood products received within 120 days before first vaccination
2. Investigational research agents received within 30 days before first vaccination
3. 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
4. Intent to participate in another study of an investigational research agent or any
other study that requires non-HVTN HIV antibody testing
5. Pregnant or breastfeeding
6. Active duty and reserve US military personnel Vaccines and other Injections
7. HIV vaccine(s) received in a prior HIV vaccine trial.
8. 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.
9. 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)
10. 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)
11. Allergy treatment with antigen injections within 30 days before first vaccination or
that are scheduled within 14 days after first vaccination Immune System
12. 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.)
13. 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.)
14. Immunoglobulin received within 60 days before first vaccination
15. Autoimmune disease, connective tissue disease, or history of vasculitis, eg,
leukocytoclastic vasculitis, Henoch-Schonlein Purpura
16. Immunodeficiency Clinically significant medical conditions
17. Untreated or incompletely treated syphilis infection
18. 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:
- A process that would affect the immune response,
- A process that would require medication that affects the immune response,
- Any contraindication to repeated injections or blood draws,
- A condition that requires active medical intervention or monitoring to avert
grave danger to the volunteer's health or well-being during the study period,
- A condition or process for which signs or symptoms could be confused with
reactions to vaccine, or
- Any condition specifically listed among the exclusion criteria below.
19. 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
20. 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.
21. Current anti-tuberculosis (TB) prophylaxis or therapy
22. Asthma exclusion criteria:
Asthma other than mild, well-controlled asthma.
Exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- In the past year has either of the following:
- Greater than 1 exacerbation of symptoms treated with oral/ parenteral
corticosteroids;
- Needed emergency care, urgent care, hospitalization, or intubation for asthma
23. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
24. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
25. Hypertension:
- If a person has been found to have elevated blood pressure or hypertension during
screening or previously, exclude for blood pressure that is not well controlled.
Well-controlled blood pressure is defined as consistently = 140 mm Hg systolic
and = 90 mm Hg diastolic, with or without medication, with only isolated, brief
instances of higher readings, which must be = 150 mm Hg systolic and = 100 mm Hg
diastolic. For these volunteers, blood pressure must be = 140 mm Hg systolic and
= 90 mm Hg diastolic at enrollment.
- If a person has NOT been found to have elevated blood pressure or hypertension
during screening or previously, exclude for systolic blood pressure = 150 mm Hg
at enrollment or diastolic blood pressure = 100 mm Hg at enrollment.
26. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
27. 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)
28. 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.
29. Asplenia: any condition resulting in the absence of a functional spleen
30. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
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