| 12. 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 individuals born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for 4 months following the last investigational product administration, including:
• Condoms (male or female) with or without spermicide
• Diaphragm or cervical cap with spermicide
• Intrauterine device, or contraceptive implant
• Hormonal 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 be 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: no additional contraception required
Note: The Sponsor considers the above methods of contraception to be effective. More restrictive measures may be required by the site.
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 (Appendix A and B)
9. All sexually active volunteers born male (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented method of birth control) 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.
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
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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 risk for HIV infection within 12 months prior to vaccination, 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 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
• US sites: Four or more sexual partners; Kenya site: three or more sexual partners
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 Kenyan 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 (50 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
22. Requirement for Massachusetts General Hospital – Translational and Clinical Research Center (MGH-TCRC, Boston, US) site only: NSAID/Aspirin use that cannot be held for 5 days prior to the leukapheresis procedure
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Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
50 Year(s) |
Both |