Eligibility Details:
Inclusion Criteria:
1. Healthy male and female, including transgender individuals, 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 51st
birthday on the day of first vaccination
3. Willing to comply with the requirements of the protocol and 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 vaccination 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 counselling and receive HIV test
results
6. All volunteers born female engaging in sexual activity that could lead to pregnancy
must commit to use an effective method of contraception for 4 months following
investigational product 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
8. All volunteers born female must be willing to undergo urine pregnancy tests at time
points indicated in the Schedule of Procedures (Appendix A and B)
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 first vaccination until at least 4 months after the last vaccination
to avoid exposure of partners to investigational product in ejaculate and to prevent
conception with female partners
10. 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:
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 corticosteroids (the use of topical,
nasal, or inhaled steroids is permitted), immunosuppressive, anticancer,
anti-tuberculosis or other medications considered significant by the investigator
within the previous 6 months. 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 enrolment in this
study
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 risky behavior for HIV infection within 12 months prior to vaccination
5. If female, pregnant or planning a pregnancy during the period of enrolment until 4
months after the last study vaccination; or lactating
6. Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency,
coagulopathy or platelet disorder that requires special precautions.) (Note: A
volunteer who states that he or 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)
7. Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis
C infection (for US sites: HCV Ab positive and HCV RNA positive, for African site: HCV
Ab positive only) treatment for chronic hepatitis C infection in the past year, or
active syphilis (positive RPR confirmed by TPHA); active tuberculosis (for African
site only)
8. History of splenectomy
9. Any of the following abnormal laboratory parameters listed below:
Hematology
- Absolute Neutrophil Count (ANC) - all volunteers: ≤1,000/mm3
- Absolute Lymphocyte Count (ALC) - all volunteers: ≤650/mm3
- Hemoglobin - African volunteers: <9.5 g/dl in females; <11.0 g/dl in males
- Hemoglobin - US volunteers: <10.5 g/dl in females; <11.0 g/dl in males
- Platelets - African volunteers: <100,000 cells/mm3
- Platelets - US volunteers: <125,000 cells/mm3
Chemistry
- Creatinine >1.1 x upper limit of normal (ULN)
- ALT >1.25 x ULN
- AST >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 vaccination with Investigational Product; or receipt of other
vaccine within the previous 14 days or planned receipt within 14 days after
vaccination with Investigational Product. (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 study not requiring any blood or tissue sample
collection is not an exclusion
13. Prior receipt of another investigational HIV vaccine candidate or HIV monoclonal
antibody (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a
volunteer from participation if documentation is available and the Medical Monitor
gives approval)
14. History of severe 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 prior to screening, ongoing risk for suicide, or history of suicide
attempt or gesture within the past 3 years
16. Seizure disorder: A participant who has had a seizure in the last 3 years prior to
screening is excluded. (Not excluded: a participant with a history of seizures who has
neither required medications nor had a seizure for 3 years)
17. A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy
(A history of a completely excised malignancy that is considered cured is not an
exclusion)
18. Active, serious infections requiring parenteral antibiotic, antiviral or antifungal
therapy within 30 days prior to enrolment
19. Body mass index (BMI) ≥35
20. Body weight <110 pounds (55 kg); for US sites only
21. If, in the opinion of the Principal Investigator, it is not in the best interest of
the volunteer to participate in the trial
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
