A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core)

NCT05001373 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IAVI G002
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

Brief Summary

A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  * Proportion of participants with local and systemic solicited Adverse Events (AEs) from Day 1 to Day 7 inclusive after each IP administration * Proportion of participants with Grade 2 or higher unsolicited Adverse Events (AEs), including safety laboratory (biochemical, hematological) parameters from the day of each IP administration through 28 days after each IP administration (any event AND any possibly, probably, or definitely related event) * Proportion of participants with Serious Adverse Events (SAEs) throughout the study period (any event AND any possibly, probably, or definitely related event) * Proportion of participants with Medical Attended Adverse Events (MAAEs) from the first day of IP administration through 24 weeks post final IP administration

  9 months

Secondary Outcomes (1)

• Immunogenicity

  10 months

Other Outcomes (1)

• Exploratory Immunogenicity

  10 months

Study Arms (4)

Study Group 1

EXPERIMENTAL

eOD-GT8 60mer mRNA Vaccine (100µg)

Biological: eOD-GT8 60mer mRNA Vaccine

Study Group 2

EXPERIMENTAL

eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)

Biological: Core-g28v2 60mer mRNA Vaccine; Biological: eOD-GT8 60mer mRNA Vaccine

Study Group 3

EXPERIMENTAL

eOD-GT8 60mer mRNA Vaccine (100µg) and Core-g28v2 60mer mRNA Vaccine (100µg)

Biological: Core-g28v2 60mer mRNA Vaccine; Biological: eOD-GT8 60mer mRNA Vaccine

Study Group 4

EXPERIMENTAL

Core-g28v2 60mer mRNA Vaccine (100µg)

Biological: Core-g28v2 60mer mRNA Vaccine

Interventions

Core-g28v2 60mer mRNA Vaccine BIOLOGICAL

100µg, Intramuscularly

Study Group 2; Study Group 3; Study Group 4

eOD-GT8 60mer mRNA Vaccine BIOLOGICAL

100µg, Intramuscularly

Study Group 1; Study Group 2; Study Group 3

Eligibility Criteria

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

You may qualify if:

• Healthy adults as assessed by a medical history, physical examination, and laboratory tests who are at least 18 years at the time of screening and less than 51 years at the time 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 (PI) or designee and based on Assessment of (informed consent) Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to IP administration and participation in the study; 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 women of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for at least 2 weeks prior to the first IP administration and continue until 4 months following the last IP 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.
• 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;
• All participants born female who are of reproductive potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA);
• All sexually active participants 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;

You may not qualify if:

• Positive test for HIV-1 or HIV-2;
• 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; 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's 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 participant unsuitable for participation in the study; Note: All chronic conditions must be considered stable, there can be no significant change of medications within the previous 2 months, and for diabetics HgbA1c must be \<10%.
• History of substance abuse or alcohol abuse;
• Reported behavior that puts the participant at risk for HIV infection within 6 months prior to screening, 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, herpes simplex virus-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 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 (eg, factor deficiency, coagulopathy, or platelet disorder that requires special precautions) Note: A participant who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has IM vaccinations 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 RNA positive), or active syphilis (screening and confirmatory tests);
• History of splenectomy;
• Any of the following abnormal laboratory parameters listed below at screening:

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead
• ModernaTX, Inc.: collaborator
• George Washington University: collaborator
• Fred Hutchinson Cancer Center: collaborator
• Emory University: collaborator
• UT Health San Antonio: collaborator

Study Sites (4)

George Washington University

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

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Design

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

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 11, 2021
• Study Start: November 12, 2021
• Primary Completion: June 20, 2023
• Study Completion: July 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

US (4)