A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

Key facts

Study ID: NCT03699241
Run by: International AIDS Vaccine Initiative
People needed: 61
Starts: 2018-12-03
Expected to finish: 2023-07-11
Last updated by the study team: 2023-12-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 vaccination
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 counselling and receive HIV test results
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
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
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)
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
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

You may not qualify if…

Confirmed HIV-1 or HIV-2 infection
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
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 enrolment until 4 months after the last study vaccination; or lactating
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)
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)
History of splenectomy
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)
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)

Where it is running

MGH — Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Kenya AIDS Vaccine Initiative — Nairobi, Kenya

Full record on ClinicalTrials.gov

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