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A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted

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ClinicalTrials.gov Identifier: NCT03547245
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
International AIDS Vaccine Initiative

Brief Summary:
This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers.

Condition or disease Intervention/treatment Phase
HIV/AIDS Biological: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM Biological: DPBS Sucrose Phase 1

Detailed Description:
This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative volunteers. The study is a randomized, double-blind, placebo-controlled dosage-escalation Phase 1 study intended to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in a prime-boost regimen.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Dosage Escalation Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in HIV-uninfected, Healthy Adult Volunteers
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: HIV-uninfected, healthy adults Biological: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM
20 μg

Biological: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM
100 μg

Biological: DPBS Sucrose
Placebo

Placebo Comparator: HIV-uninfected, healthy adults - placebo Biological: DPBS Sucrose
Placebo




Primary Outcome Measures :
  1. Safety and Tolerability: frequency of local and systemic reactogenicity events [ Time Frame: 7 days ]
    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).

  2. Safety and Tolerability: proportion of volunteers with moderate or greater unsolicited adverse events [ Time Frame: 16 months ]
    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).

  3. Safety and Tolerability: proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) [ Time Frame: 16 months ]
    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.


Secondary Outcome Measures :
  1. Immunogenicity: Frequency of responses [ Time Frame: 16 months ]
    To evaluate the frequency of eOD-GT8 60mer-specific, eOD-GT8 monomer-specific, and epitope-specific serum antibody responses after 1st and/or 2nd immunization compared to baseline and placebo

  2. Immunogenicity: Magnitude of responses [ Time Frame: 16 months ]
    To evaluate the magnitude of eOD-GT8 60mer-specific, eOD-GT8 monomer-specific, and epitope-specific serum antibody responses after 1st and/or 2nd immunization compared to baseline and placebo



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests;
  2. At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first IP administration;
  3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
  4. 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;
  5. Willing to undergo HIV testing, risk reduction counseling and receive HIV test result;
  6. All heterosexually active female volunteers must commit to use an effective method of contraception for 4 months following investigational product administration
  7. All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures and must test negative prior to each study vaccination;
  8. All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier method of birth control) 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 ;
  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;
  10. Women, who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become hetero-sexually active, as outlined above.

Exclusion Criteria:

  1. 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, nasal or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months;
  2. 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;
  3. 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;
  4. Reported risky behavior for HIV infection within 12 months prior to vaccination
  5. If female, pregnant or planning a pregnancy during the period of enrollment until 4 months after the last study vaccination; or lactating;
  6. Bleeding disorder that was diagnosed by a physician (e.g., clotting 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 had IM vaccine administrations and blood draws without any adverse experience, is eligible);
  7. Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA positive) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA);
  8. Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with Investigational Product; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product. (Exception is live attenuated influenza vaccine within 14 days);
  9. History of splenectomy;
  10. Receipt of blood transfusion or blood-derived products within the previous 3 months;
  11. Any of the following abnormal laboratory parameters listed below:

    Hematology

    • Hematocrit: <35%
    • Absolute Neutrophil Count (ANC): ≤1,000/mm3
    • Absolute Lymphocyte Count (ALC): ≤650/mm3
    • Platelets: <125,000 cells/mm3 Chemistry
    • Creatinine >1.1 x upper limit of normal (ULN)
    • ALT >1.25 x ULN
    • AST >1.25 x ULN Urinalysis
    • Clinically significant abnormal dipstick confirmed by microscopy:
    • Protein = 1+ or more
    • Blood = 2+ or more (not due to menses)
  12. Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study (Concurrent participation in an observational trial not requiring any blood or tissue sample collection is not an exclusion);
  13. Prior receipt of another investigational HIV vaccine candidate (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval);
  14. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration);
  15. Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years (prior to screening), ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years;
  16. Seizure disorder: A volunteer who has had a seizure in the last 3 years (prior to screening) is excluded. (Not excluded: a volunteer with a history of seizures who has neither required medications nor had a seizure for 3 years);
  17. A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy (A history of a completely excised malignancy that is considered cured is not an exclusion);
  18. Active, serious infections requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment;
  19. Body mass index ≥35 ;
  20. Body weight <110 pounds (55 kg);
  21. If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547245


Contacts
Contact: Frances Priddy, MD, MPH 1-212-847-1111 fpriddy@iavi.org

Locations
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact    202-994-8976    mitmclintrials@gwu.edu   
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Kim Louis    425-610-6448    info@seattlevaccines.org   
Sponsors and Collaborators
International AIDS Vaccine Initiative
Investigators
Principal Investigator: David Diemert, MD, FRCP(C) George Washington University School of Medicine & Health Sciences
Principal Investigator: Julie McElrath, MD, PhD Seattle HIV Vaccine Trials Unit

Additional Information:
Responsible Party: International AIDS Vaccine Initiative
ClinicalTrials.gov Identifier: NCT03547245     History of Changes
Other Study ID Numbers: G001
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No