| Eligibility |
Inclusion Criteria:
1. Healthy adults as assessed by a medical history, physical exam, and laboratory tests;
2. At least 18 years of age on the day of screening and has not reached his/her 51
birthday on the day of first IP administration;
3. Willing to comply with the requirements of the protocol and be available for follow-up
for the planned duration of the study;
4. In the opinion of the Principal Investigator or designee and based on Assessment of
Informed Consent Understanding results, has understood the information provided and
potential impact and/or risks linked to IP administration and participation in the
trial; written informed consent will be obtained from the volunteer before any
study-related procedures are performed;
5. Willing to undergo HIV testing, risk reduction counseling and receive HIV test
results;
6. All volunteers born female who are engaging in sexual activity that could lead to
pregnancy must commit to use an effective method of contraception at the time of the
first IP administration and for 4 months following the last IP administration.
7. All volunteers 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 volunteers born female must be willing to undergo urine pregnancy tests at time
points indicated in the Schedule of Procedures
9. All sexually active volunteers born male, regardless of reproductive potential, must
be willing to use an effective method of contraception (such as consistent condom use)
from the day of the first IP administration until at least 4 months after the last IP
administration;
10. Willing to forgo donations of blood, or any other tissues during the study and, for
those who test HIV-positive due to IP-induced antibodies, until the anti-HIV antibody
titers become undetectable.
11. For sites in the European Union (EU), consent to the collection and use of personal
data in compliance with the General Data Protection Regulation (GDPR)
Exclusion Criteria:
1. Confirmed HIV-1 or HIV-2 infection;
2. 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,
antituberculosis or other medications considered significant by the investigator
within the previous 6 months;
3. Any clinically significant acute or chronic medical condition that is considered
progressive or in the opinion of the investigator makes the volunteer unsuitable for
participation in the study;
4. Reported behavior which put the volunteer at risk for HIV infection within 6 months
prior to IP 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 (i.e., 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 (PID), trichomonas, mucopurulent
cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or
hepatitis B or hepatitis C;
- Three or more sexual partners
5. If female, pregnant or planning a pregnancy during the period of enrolment until 4
months after the last IP administration; or lactating;
6. Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency,
coagulopathy or platelet disorder that requires special precautions)
7. Infectious disease diagnosis: chronic hepatitis B infection (HbsAg-positive), current
hepatitis C infection (HCV Ab positive and HCV 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);
8. History of splenectomy;
9. 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)
10. Receipt of live attenuated vaccine within the previous 30 days or planned receipt
within 30 days after IP administration; or receipt of other vaccine within the
previous 14 days or planned receipt within 14 days after IP administration. (Exception
is live attenuated influenza vaccine within 14 days.);
11. Receipt of blood transfusion or blood-derived products within the previous 3 months;
12. Participation in another clinical trial of an investigational product currently,
within the previous 3 months or expected participation during this study; concurrent
participation in an observational trial not requiring blood or tissue sample
collection is not an exclusion;
13. Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody
Note: receipt of placebo in a previous HIV vaccine trial or monoclonal antibody trial
will not exclude a volunteer from participation if documentation is available and the
Medical Monitor gives approval;
14. History of significant local or systemic reactogenicity to vaccines (e.g.,
anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or
ulceration);
15. Psychiatric condition that compromises safety of the volunteer 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;
16. Seizure disorder: A volunteer who has had a seizure in the last 3 years is excluded.
(Not excluded: a volunteer with a history of seizures who has neither required
medications nor had a seizure for 3 years);
17. History of malignancy in the past 5 years (prior to screening) or ongoing malignancy
(a history of completely excised malignancy that is considered cured is not an
exclusion);
18. Active, serious infections requiring antibiotic, antiviral or antifungal therapy
within 30 days prior to enrolment;
19. Body mass index (BMI) =35;
20. Body weight <110 pounds (50 kg);
21. Prior daily use of NSAID/aspirin that cannot be held for 5 days prior to the
leukapheresis procedure (if required by the study site);
22. If, in the opinion of the Principal Investigator, it is not in the best interest of
the volunteer to participate in the trial.
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