A Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644)

NCT05414786 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IAVI G003
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief Summary

A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.

Conditions

HIV-1-infection

Keywords

eOD-GT8 60mer mRNA Vaccine

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of eOD-GT8 60mer mRNA Vaccine

  To evaluate the safety and tolerability of eOD-GT8 60mer mRNA Vaccine, including local and systemic solicited AEs from Day 1 to Day 7 inclusive after each IP administration, Grade 2 or higher unsolicited AEs from the day of each IP administration through 28 days after, participants with SAEs throughout the study period and participants with MAAEs and AESIs from the first day of IP administration through 24 weeks post final IP administration

  16 months

Study Arms (1)

Experimental group

EXPERIMENTAL

* 2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart * No control group. There is no blinding and no randomization in this open label study

Biological: eOD-GT8 60mer mRNA Vaccine (100µg)

Interventions

eOD-GT8 60mer mRNA Vaccine (100µg) BIOLOGICAL

* 2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart * No control group. There is no blinding and no randomization in this open label study

Experimental group

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 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 counselling 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 at least 4 weeks prior to the first IP administration and for 4 months following the last IP administration. Effective contraception includes:
• Intrauterine device
• Hormonal contraception, including contraceptive implant or injectable
• 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 must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOAs) (APPENDIX A or APPENDIX B);
• 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; Note: For Center for Family Health Research (CFHR) site, males in monogamous relationships whose partners are on a documented and effective contraceptive method will be exempt from this requirement.
• 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.

You may not qualify if:

• Positive test for 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; 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 IP administration) 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 participant unsuitable for participation in the study;
• History of substance abuse or alcohol abuse;
• Reported behaviour 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 (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, herpes simplex virus-2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B-or hepatitis C;
• Two 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) 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), hepatitis C infection (HCV Ab-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
• AURUM Tembisa Clinical Research: collaborator
• Center for Family Health Research: collaborator
• ModernaTX, Inc.: collaborator

Study Sites (2)

Center for Family Health Research

Kigali, 250, Rwanda

Location

Aurum Tembisa Clinical Research Centre

Johannesburg, 1332, South Africa

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

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: May 26, 2022
• First Posted: June 10, 2022
• Study Start: May 25, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Information will be shared as soon as results are publicly available for the investigational product being used in similar studies conducted in other regions. The existing results and data upon which the G003 study is based is yet to be made fully publicly available.
• Access Criteria: Access to data will be determined by the study team, partners and funding agencies.

Locations

ZA (1); RW (1)