A 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

NCT04224701 | Completed Phase 1 FDA Drug

• 1 other identifier: IAVI C101
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (5)

• Safety - reactogenicity

  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

  7 Days

• Safety - IP related unsolicited adverse events

  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

  28 days

• Safety - Grade 2 or greater unsolicited AEs

  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

  28 days

• Safety - IP related SAEs

  Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period

  18 Months

• Safety - pIMDs

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

  18 Months

Secondary Outcomes (2)

• Immunogenicity - Frequency Ab responses

  6 Months

• Immunogenicity - Magnitude Ab responses

  6 Months

Study Arms (2)

Investigational Product, 30 µg/ Placebo

EXPERIMENTAL

30 µg IM, months 0, 2 and 6

Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted; Biological: Placebo

Investigational Product, 300 µg/ Placebo

EXPERIMENTAL

300 µg IM, months 0, 2 and 6

Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted; Biological: Placebo

Interventions

BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted BIOLOGICAL

30 µg

Investigational Product, 30 µg/ Placebo

Placebo BIOLOGICAL

Tris NaCl Diluent

Investigational Product, 30 µg/ Placebo; Investigational Product, 300 µg/ Placebo

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;
• 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.
• For sites in the European Union (EU), consent to the collection and use of personal data in compliance with the General Data Protection Regulation (GDPR)

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, 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;
• Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions)
• Infectious disease diagnosis: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV 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:
• Hematology

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• GlaxoSmithKline: collaborator
• Rockefeller University: collaborator
• George Washington University: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (3)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Rockefeller University

New York, New York, 10065, United States

Location

The Amsterdam University Medical Centers

Amsterdam, Netherlands

Location

Related Publications (1)

• Libera M, Caputo V, Laterza G, Moudoud L, Soggiu A, Bonizzi L, Diotti RA. The Question of HIV Vaccine: Why Is a Solution Not Yet Available? J Immunol Res. 2024 Apr 8;2024:2147912. doi: 10.1155/2024/2147912. eCollection 2024.

  PMID: 38628675 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Marina Caskey, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

• Godelieve de Bree, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• David Joseph Diemert, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 13, 2020
• Study Start: August 1, 2020
• Primary Completion: July 5, 2023
• Study Completion: August 2, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (2); NL (1)