A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers. The study is a randomized, double-blind, placebo-controlled dosage-escalation Phase 1 study intended to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in a prime-boost regimen.

Inclusion criteria

• Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests;
• At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first IP administration;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
• 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;
• Willing to undergo HIV testing, risk reduction counseling and receive HIV test result;
• All heterosexually active female volunteers must commit to use an effective method of contraception for 4 months following investigational product administration
• All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to each study vaccination;
• All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier 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 ;
• 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;
• Women, who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become hetero-sexually active, as outlined above.

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, 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 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 volunteer unsuitable for participation in the study;
• Reported risky behavior for HIV infection within 12 months prior to vaccination
• If female, pregnant or planning a pregnancy during the period of enrollment until 4 months after the last study vaccination; or lactating;
• Bleeding disorder that was diagnosed by a physician (e.g., clotting 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 had IM vaccine administrations and blood draws without any adverse experience, is eligible);
• Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA positive) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA);
• 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);
• History of splenectomy;
• Receipt of blood transfusion or blood-derived products within the previous 3 months;
• Any of the following abnormal laboratory parameters listed below:

Hematology

• Hematocrit: <35%
• Absolute Neutrophil Count (ANC): ≤1,000/mm3
• Absolute Lymphocyte Count (ALC): ≤650/mm3
• Platelets: <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)
• 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 any blood or tissue sample collection is not an exclusion);
• Prior receipt of another investigational HIV vaccine candidate (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);
• History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration);
• 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;
• Seizure disorder: A volunteer who has had a seizure in the last 3 years (prior to screening) is excluded. (Not excluded: a volunteer with a history of seizures who has neither required medications nor had a seizure for 3 years);
• 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);
• Active, serious infections requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment;
• Body mass index ≥35 ;
• Body weight <110 pounds (55 kg);
• If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.