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
NCT ID: NCT03699241
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2018-12-03
2023-07-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
HIV-Uninfected participants
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 30ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Group 2
HIV-Uninfected participants
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 100ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Group 3
HIV-Uninfected participants
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 300ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Group 4
HIV-Uninfected participants
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 30ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Group 5
HIV-Uninfected participants
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 100ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 30ug, Intramuscular administration
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 100ug, Intramuscular administration
BG505 SOSIP.664 gp140, adjuvanted
Dosage of 300ug, Intramuscular administration
Placebo
Tris-NaCl Diluent
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials Unit
UNKNOWN
Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)
UNKNOWN
Massachusetts General Hospital
OTHER
International AIDS Vaccine Initiative
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie McElrath, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle HIV Vaccine Trials Unit
Omu Anzala, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)
Boris Juelg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MGH
Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Kenya AIDS Vaccine Initiative
Nairobi, , Kenya
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IAVI W001
Identifier Type: -
Identifier Source: org_study_id