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

NCT03699241 | Completed Phase 1 FDA Drug

• 1 other identifier: IAVI W001
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 3

Brief Summary

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination

  To evaluate the safety and tolerability of the study regimens based on the frequency of local and systemic reactogenicity events as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

  7 days post-vaccination

• Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination

  To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with moderate or greater unsolicited adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

  28 days post-vaccination

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

  To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with vaccine-related serious adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

  18 months

• Proportion of volunteers in each group with potential immune-mediated diseases (pIMD) from the day of injection throughout the study period

  To evaluate the proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) based on a defined list of pIMDs in the study protocol.

  18 months

Secondary Outcomes (5)

• To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

  20 months

• To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

  20 months

• To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

  20 months

• To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

  20 months

• To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

  20 months

Study Arms (5)

Group 1

PLACEBO COMPARATOR

HIV-Uninfected participants

Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

Group 2

PLACEBO COMPARATOR

HIV-Uninfected participants

Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

Group 3

PLACEBO COMPARATOR

HIV-Uninfected participants

Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

Group 4

PLACEBO COMPARATOR

HIV-Uninfected participants

Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

Group 5

PLACEBO COMPARATOR

HIV-Uninfected participants

Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

Interventions

BG505 SOSIP.664 gp140, adjuvanted BIOLOGICAL

Dosage of 30ug, Intramuscular administration

Group 1; Group 4

Placebo BIOLOGICAL

Tris-NaCl Diluent

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female, including transgender individuals, 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 51st birthday on the day of first vaccination
• Willing to comply with the requirements of the protocol and 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 vaccination 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 counselling and receive HIV test results
• 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
• 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
• 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)
• 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
• 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 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
• 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 risky behavior for HIV infection within 12 months prior to vaccination
• If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last study vaccination; or lactating
• 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)
• 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)
• History of splenectomy
• 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

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• GlaxoSmithKline: collaborator
• Fred Hutchinson Cancer Research Center - Seattle HIV Vaccine Trials Unit: collaborator
• Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

MGH

Boston, Massachusetts, 02114, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Kenya AIDS Vaccine Initiative

Nairobi, Kenya

Location

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

• Julie McElrath, MD, PhD

  Seattle HIV Vaccine Trials Unit

  PRINCIPAL INVESTIGATOR

• Omu Anzala, MBChB, PhD

  Kenya AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR)

  PRINCIPAL INVESTIGATOR

• Boris Juelg, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: December 3, 2018
• Primary Completion: March 21, 2023
• Study Completion: July 11, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

KE (1); US (2)