| Eligibility |
Inclusion:
- Healthy adults as assessed by a medical history, physical exam, and laboratory tests
- Received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- Willing to comply with the requirements of the protocol and be available for follow-up
for the planned duration of the study
- In the opinion of the Principal Investigator (PI) or designee and based on Assessment
of Understanding (AOU) results, has understood the information provided and potential
impact and/or risks linked to vaccine administration and participation in the trial;
written informed consent will be obtained from the participant before any
study-related procedures are performed
- Willing to undergo HIV testing, risk reduction counseling and receive HIV-test results
- All participants born female who are engaging in sexual activity that could lead to
pregnancy must commit to use an effective method of contraception starting 2 weeks
before the first vaccine administration and for 4 months following the last vaccine
administration. Effective contraception includes:
- Condoms (male or female) with or without spermicide
- Diaphragm or cervical cap with spermicide
- Intrauterine device
- Hormonal contraception, including contraceptive implant or injectable
- Oral contraception
- Successful vasectomy in the male partner
Considered successful if a woman reports that a male partner has:
1. documentation of azoospermia by microscopy (1 year ago) or
2. a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity
post vasectomy • Not of reproductive potential Such as having undergone hysterectomy,
bilateral oophorectomy, or tubal ligation, postmenopausal (=45 years of age with
amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and
a serum follicle stimulating hormone (FSH) level > 40 IU/L), surgically sterile Note:
More restrictive measures may be required by the study sites. 7. All participants born
female who are not heterosexually active at screening must agree to utilize an
effective method of contraception if they become heterosexually active as outlined
above 8. All participants born female must be willing to undergo urine pregnancy tests
at time points indicated in the Schedule of Assessments (SOA) (Appendix A) 9. Willing
to forgo donations of blood, or any other tissues during the study and, for those who
test HIV-positive due to vaccine-induced antibodies, until the anti-HIV-antibody
titers become undetectable
Exclusion Criteria
- Confirmed HIV-1 or HIV-2 infection
- Any clinically relevant abnormality on history or examination, including history of
immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of
topical or inhaled steroids is permitted), immunosuppressive, anticancer,
anti-tuberculosis or other medications considered significant by the Investigator
within the previous 6 months.
Note: The following exceptions are permitted and will not exclude study participation: use
of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute
uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single
injection) of corticosteroid for a non-chronic condition (based on Investigator clinical
judgment) at least 2 weeks prior to enrollment in this study.
- Any clinically significant acute or chronic medical condition that is considered
progressive or in the opinion of the Investigator makes the participant unsuitable for
participation in the study
- Reported behavior that put the participant at risk for HIV infection within 6 months
prior to vaccine administration, as defined by:
- Unprotected sexual intercourse with a known HIV-infected person, a partner known to be
at high risk for HIV infection or a casual partner (ie, no continuing established
relationship)
- Engaged in sex work
- Frequent excessive daily alcohol use or frequent binge drinking, or any other use of
illicit drugs
- History of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2,
chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis,
epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or
hepatitis C
- Three or more sexual partners
- If female, pregnant, lactating, or planning a pregnancy during the period of
enrollment until 4 months after the last vaccine administration
- Bleeding disorder that was diagnosed by a physician (eg, clotting factor deficiency,
coagulopathy or platelet disorder that requires special precautions) Note: A
participant who states that he/she has easy bruising or bleeding, but does not have a
formal diagnosis and has IM injections and blood draws without any adverse experience
is eligible
- Infectious disease diagnosis: chronic hepatitis B infection (HbsAg-positive), current
hepatitis C infection (HCV Ab positive and HCV ribonucleic acid (RNA) positive or
interferon-alfa treatment for hepatitis C infection in the past year or
interferon-alfa-free treatment for hepatitis C infection completed in the past 6
months), or active syphilis (screening and confirmatory tests)
- History of splenectomy
- Any of the following abnormal laboratory parameters listed below:
Hematology
- Hemoglobin - <10.5 g/dl or <6.5 mmol/L in females; <11.0 g/dl or <6.8 mmol/L in males
- Absolute Neutrophil Count (ANC) - =1,000/mm3 or < 1.0 x 109 cells/L
- Absolute Lymphocyte Count (ALC) - =650/mm3 or < 0.65 x 109 cells/L
- Platelets - <125,000 cells/mm3 or <125 x 109 cells/L Chemistry
- Creatinine - >1.1 x upper limit of normal (ULN)
- AST - >1.25 x ULN
- ALT - >1.25 x ULN Urinalysis
Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 1+ or more
- Blood = 2+ or more (not due to menses)
- Receipt of live attenuated vaccine within the previous 30 days or planned receipt
within 30 days after vaccine administration; or receipt of other vaccine within the
previous 14 days or planned receipt within 14 days after vaccine administration.
(Exception is live attenuated influenza vaccine within 14 days.)
- Receipt of blood transfusion or blood-derived products within the previous 3 months
- Participation in another clinical trial of a vaccine currently, within the previous 3
months or expected participation during this study (with the exception of Protocol
IAVI C101); concurrent participation in an observational trial not requiring blood or
tissue sample collection is not an exclusion
- Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody
other than BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
- History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis,
respiratory difficulties, angioedema, injection site necrosis or ulceration)
- Psychiatric condition that compromises safety of the participant and 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
- Seizure disorder: A participant who has had a seizure in the last 3 years is excluded.
(Not excluded: a participant with a history of seizures who has neither required
medications nor had a seizure for 3 years)
- History of malignancy in the past 5 years (prior to screening) or ongoing malignancy
(a history of completely excised malignancy, which is considered cured, is not an
exclusion)
- Active, serious infections requiring antibiotic, antiviral, or antifungal therapy
within 30 days prior to enrollment
- Body mass index (BMI) =35
- Body weight <110 pounds (50 kg)
- Prior daily use of NSAID/aspirin that cannot be held for 5 days prior to the
leukapheresis procedure (if required by the study site)
- If, in the opinion of the PI, it is not in the best interest of the participant to
participate in the trial
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