A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- HIV Infections
- Sponsor
- International AIDS Vaccine Initiative
- Enrollment
- 48
- Locations
- 3
- Primary Endpoint
- Safety - Grade 2 or greater unsolicited AEs
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
Detailed Description
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. BG505 SOSIP.GT1.1 is a soluable, cleavage-competent, trimeric HIV-1 envelope glycoprotein gp140 formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100 mM naCL, pH 7.5 and will be administered IM.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults 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 51 birthday on the day of first IP administration;
- •Willing to comply with the requirements of the protocol and be 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 IP administration 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 results;
- •All volunteers born female who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception at the time of the first IP administration and for 4 months following the last IP 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 as outlined above;
- •All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures
- •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 the first IP administration until at least 4 months after the last IP administration;
- •Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to IP-induced antibodies, until the anti-HIV antibody titers become undetectable.
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 or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months;
- •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 behavior which put the volunteer at risk for HIV infection within 6 months prior to IP administration, 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 other 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 or hepatitis C;
- •Three or more sexual partners
- •If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last IP administration; or lactating;
Arms & Interventions
Investigational Product, 300 µg/ Placebo
300 µg IM, months 0, 2 and 6
Intervention: Placebo
Investigational Product, 30 µg/ Placebo
30 µg IM, months 0, 2 and 6
Intervention: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted
Investigational Product, 30 µg/ Placebo
30 µg IM, months 0, 2 and 6
Intervention: Placebo
Investigational Product, 300 µg/ Placebo
300 µg IM, months 0, 2 and 6
Intervention: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted
Outcomes
Primary Outcomes
Safety - Grade 2 or greater unsolicited AEs
Time Frame: 28 days
Proportion of volunteers with Grade 2 or greater unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Safety - IP related SAEs
Time Frame: 18 Months
Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period
Safety - IP related unsolicited adverse events
Time Frame: 28 days
Proportion of volunteers with IP-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Safety - pIMDs
Time Frame: 18 Months
Proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) from the day of first IP administration throughout the study period
Safety - reactogenicity
Time Frame: 7 Days
Proportion of volunteers with Grade 2 or greater reactogenicity (i.e., solicited adverse events) from Day 0 through Day 7 after each investigational product (IP) administration
Secondary Outcomes
- Immunogenicity - Frequency Ab responses(6 Months)
- Immunogenicity - Magnitude Ab responses(6 Months)