A Clinical Trial to Evaluate the Safety and Immunogenicity of a Prophylactic HIV Vaccine Candidate

NCT05863585 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IAVI C107
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

Conditions

Hiv

Outcome Measures

Primary Outcomes (5)

• To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  Proportion of participants with Grade 2 or greater reactogenicity (ie, solicited AEs) from Day 0 through Day 7 after each vaccine administration

  7 days

• To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  Proportion of participants with vaccine-related unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration

  28 days

• To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  Proportion of participants with Grade 2 or greater unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration

  28 days

• To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  Proportion of participants with vaccine-related SAEs throughout the study period

  1 year

• To evaluate safety and tolerability of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  Proportion of participants in each group with potential immune-mediated diseases (pIMDs) from the day of first vaccine administration throughout the study period

  1 year

Secondary Outcomes (1)

• To determine the immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

  1 year

Study Arms (1)

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

EXPERIMENTAL

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage

Drug: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

Interventions

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) DRUG

100µg

BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults as assessed by a medical history, physical exam, and laboratory tests
• Received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
• 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 (PI) or designee and based on Assessment of Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to vaccine administration and participation in the trial; written informed consent will be obtained from the participant before any study-related procedures are performed
• Willing to undergo HIV testing, risk reduction counseling and receive HIV-test results
• All participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception starting 2 weeks before the first vaccine administration and for 4 months following the last vaccine administration. Effective contraception includes:
• Condoms (male or female) with or without spermicide
• Diaphragm or cervical cap with spermicide
• Intrauterine device
• Hormonal contraception, including contraceptive implant or injectable
• Oral contraception
• Successful vasectomy in the male partner
• Considered successful if a woman reports that a male partner has:
• documentation of azoospermia by microscopy (1 year ago) or
• a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy • Not 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 Note: More restrictive measures may be required by the study sites. 7. All participants 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 participants born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Assessments (SOA) (Appendix A) 9. 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 systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the Investigator within the previous 6 months.
• Note: 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 participant unsuitable for participation in the study
• Reported behavior that put the participant at risk for HIV infection within 6 months prior to vaccine 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 (ie, 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, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or hepatitis C
• Three or more sexual partners
• If female, pregnant, lactating, or planning a pregnancy during the period of enrollment until 4 months after the last vaccine administration
• Bleeding disorder that was diagnosed by a physician (eg, clotting factor deficiency, coagulopathy or platelet disorder that requires special precautions) Note: A participant who states that he/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 diagnosis: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV ribonucleic acid (RNA) positive or interferon-alfa treatment for hepatitis C infection in the past year or interferon-alfa-free treatment for hepatitis C infection completed in the past 6 months), or active syphilis (screening and confirmatory tests)
• History of splenectomy
• Any of the following abnormal laboratory parameters listed below:

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• Access to Advanced Health Institute (AAHI): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

aluminum sulfate

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Dagna Laufer, MD

CONTACT

212-328-7459; dlaufer@iavi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05