‘A clinical trial to test the safety and immune responses from the BG505 SOSIP.664 gp140 HIV vaccine in development’.
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202006565880683
- Lead Sponsor
- IAVI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Tolerability:<br>1. Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination<br>2.Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each vaccination up to 28 days post each vaccination <br>3.Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period<br>4.Proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) from the day of injection throughout the study period<br>
- Secondary Outcome Measures
Name Time Method Secondary Endpoints<br>Immunogenicity:<br>To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:<br>1.Proportion of volunteers with neutralizing antibodies against autologous BG505 SOSIP.664 gp140 Vaccine, Adjuvanted<br>2.Proportion of volunteers with and magnitude of trimer binding antibodies to BG505 SOSIP.664 gp140 Vaccine, Adjuvanted<br>3.Proportion of volunteers with neutralizing antibodies against additional viral strains (e.g., Tier 1a/b, Tier 2) <br>4.Proportion of volunteers with and magnitude of binding antibodies to HIV Env<br>5.Proportion of volunteers with HIV Env specific B and T-cell responses<br>