| Eligibility |
Inclusion Criteria
General and Demographic Criteria
- Age of 18 to 50 years
- Access to a participating HVTN Clinical Research Site (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 after completion of scheduled clinic visits for a total of 2
years following initial study injection
- Agrees not to enroll in another study of an investigational research agent while in
this study
- Good general health as shown by medical history, physical exam, and screening
laboratory tests
HIV-Related Criteria:
- 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 (see the study protocol).
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female
sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male
sex at birth. For transgender participants who have been on hormone therapy for more
than 6 consecutive months, determine hemoglobin eligibility based on the gender with
which they identify (ie, a transgender female who has been on hormone therapy for more
than 6 consecutive months should be assessed for eligibility using the hemoglobin
parameters for persons assigned female sex at birth).
- White blood cell count equal to 2,500 to 12,000 cells/mm^3 with normal differential,
or differential approved by Investigator of Record (IoR) as not clinically significant
- Total lymphocyte count greater than or equal to 650 cells/mm^3 with normal
differential, or differential approved by IoR as not clinically significant
- Remaining differential either within institutional normal range or with site physician
approval
- Platelets equal to 125,000 to 550,000 cells/mm^3
Chemistry
- Chemistry panel: alanine aminotransferase (ALT) less than 1.25 times the institutional
upper limit of normal; creatinine less than or equal to 1.1 times the institutional
upper limits of normal.
HIV Status
- Negative HIV-1 and -2 blood test: US volunteers must have a negative U.S. Food and
Drug Administration (FDA)-approved enzyme immunoassay (EIA).
Urine
- Normal urine:
- Negative or trace urine protein, and
- Negative, trace, or 1+ blood urine hemoglobin (if +1 hemoglobin is present on
dipstick, a microscopic urinalysis with red blood cells levels within
institutional normal range).
Reproductive Status
- Volunteers who were assigned female sex at birth: negative serum or urine beta human
chorionic gonadotropin (ß-HCG) pregnancy test at screening (ie, prior to
randomization) and prior to study product administration on the day of study product
administration. Persons who are NOT of reproductive potential due to having undergone
hysterectomy or bilateral oophorectomy (verified by medical records), are not required
to undergo pregnancy testing.
- Reproductive status: A volunteer who was assigned female sex at birth:
- Must agree to consistently use effective contraception (see the study protocol)
for sexual activity that could lead to pregnancy from at least 21 days prior to
enrollment until 3 months after the final study vaccination. 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,
- Tubal ligation, or
- Any other contraceptive method approved by the HVTN 132 Protocol Safety
Review Team (PSRT)
- Successful vasectomy in any partner assigned male sex at birth (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 not be of reproductive potential, such as having reached menopause (no menses
for 1 year) or having undergone hysterectomy, or bilateral oophorectomy;
- Or be sexually abstinent.
- Volunteers who were assigned female sex at birth 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) greater than or equal to 40.
- Volunteer has 2 or more of the following cardiac risk factors:
- Participant report of history of elevated blood cholesterol defined as fasting
low-density lipoprotein (LDL) greater than 160 mg/dL;
- First degree relative (eg, mother, father, brother, or sister) who had coronary
artery disease before the age of 50 years;
- Current smoker; or
- BMI greater than or equal to 35.
- Intent to participate in another study of an investigational research agent or any
other study that requires non-HVTN HIV antibody testing during the planned duration of
the HVTN 132 study.
- Pregnant or breastfeeding.
- Active duty and reserve US military personnel.
Vaccines and other Injections
- Smallpox vaccine received within the last 5 years.
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 132 PSRT will determine eligibility
on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine
trial. Exceptions may be made by the HVTN 132 PSRT for vaccines that have subsequently
undergone licensure by the FDA or by the national regulatory authority where the
volunteer is enrolling. For volunteers who have received control/placebo in an
experimental vaccine trial, the HVTN 132 PSRT will determine eligibility on a
case-by-case basis. For volunteers who have received an experimental vaccine(s)
greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 132
PSRT on a case-by-case basis.
- Live attenuated vaccines received within 30 days before first study injection or
scheduled within 14 days after the first study injection (eg, measles, mumps, and
rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated
influenza vaccine.)
- 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
corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course
of oral/parenteral prednisone or equivalent at doses less than or equal to 60 mg/day
and length of therapy less than 11 days with completion at least 30 days prior to
enrollment.)
- Serious adverse reactions to vaccines or to vaccine components such as mannitol,
aluminum hydroxide, and egg products, 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 non-anaphylactic adverse
reaction to pertussis vaccine as a child.)
- Immunoglobulin received within 60 days before first vaccination.
- Autoimmune disease, current or history (Not exclusionary: mild, well-controlled
psoriasis.)
- Immunodeficiency.
Cardiac
- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
permanent sequelae, clinically significant arrhythmia (including any arrhythmia
requiring medication, treatment, or clinical follow-up.)
- Electrocardiography (ECG) with clinically significant findings, or features that would
interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab
or cardiologist, including any of the following: (1) conduction disturbance (complete
left or complete right bundle branch block or nonspecific intraventricular conduction
disturbance with QRS greater than or equal to 120 ms, PR interval greater than or
equal to 220ms, any second or third degree atrioventricular (AV) block, or QTc
prolongation (greater than 450ms)); (2) repolarization (ST segment or T wave)
abnormality that will interfere with the assessment of myo/pericarditis; (3)
significant atrial or ventricular arrhythmia; (4) frequent atrial or ventricular
ectopy (eg, frequent premature atrial contractions, 2 premature ventricular
contractions in a row); (5) ST elevation consistent with ischemia; (6) evidence of
past or evolving myocardial infarction.
Clinically significant medical conditions
- 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.
- 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 other than mild or moderate, 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:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses high dose inhaled corticosteroids, or
- In the past year has had 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.
- Diabetes mellitus type 1 or type 2 (Not exclusionary: type 2 cases controlled with
diet alone or a history of isolated gestational diabetes.)
- Thyroidectomy, or thyroid disease requiring medication during the last 12 months. (Not
exclusionary: well-controlled non-autoimmune thyroid disease.)
- 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 in this protocol as consistently less
than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic,
with or without medication, with only isolated, brief instances of higher
readings, which must be less than or equal to 150 mm Hg systolic and less than or
equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less
than or equal to 140 mm Hg systolic and less than or equal to 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 greater than
or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or
equal to 100 mm Hg at enrollment.
- Bleeding disorder (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 generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary:
angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction
to demonstrate satisfactory avoidance of trigger.)
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