HIV/AIDSPhase 1NCT03547245
A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted
A Phase 1 study testing eOD-GT8 60mer + AS01B/ DPBS sucrose/IM and DPBS Sucrose in people with HIV/AIDS, run by International AIDS Vaccine Initiative at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- eOD-GT8 60mer + AS01B/ DPBS sucrose/IM and DPBS Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2018to 13 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 IP administration;
- 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 counseling and receive HIV test result;
- All heterosexually active female volunteers must commit to use an effective method of contraception for 4 months following investigational product administration
Show all 10Show fewer
- 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;
- 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 ;
- 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;
- 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.
Who cannot join
- 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;
- 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;
- 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 enrollment until 4 months after the last study vaccination; or lactating;
- 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);
Show all 32Show fewer
- 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);
- 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);
- History of splenectomy;
- Receipt of blood transfusion or blood-derived products within the previous 3 months;
- 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)
- 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);
- 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);
- History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration);
- 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;
- 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);
- 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);
- Active, serious infections requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment;
- Body mass index ≥35 ;
- Body weight <110 pounds (55 kg);
- If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
George Washington University
Washington D.C., District of Columbia, 20037
About this study
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
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- eOD-GT8 60mer + AS01B/ DPBS sucrose/IM, DPBS Sucrose
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eOD-GT8 60mer + AS01B/ DPBS sucrose/IMBiological
20 μg
eOD-GT8 60mer + AS01B/ DPBS sucrose/IMBiological
100 μg
DPBS SucroseBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HIV-uninfected, healthy adults | Active comparator | Not described Receives: Biological: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM; Biological: DPBS Sucrose |
| HIV-uninfected, healthy adults - placebo | Placebo comparator | Not described Receives: Biological: DPBS Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: frequency of local and systemic reactogenicity events
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).
Measured: 7 days
Safety and Tolerability: proportion of volunteers with moderate or greater unsolicited adverse events
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).
Measured: 16 months
Safety and Tolerability: proportion of volunteers in each group with potential immune-mediated diseases (pIMDs)
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.
Measured: 16 months
Secondary outcomes (2)
Immunogenicity: Frequency of responses
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
Measured: 16 months
Immunogenicity: Magnitude of responses
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
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start15 Jun 2018
- Primary completion17 Jan 2020
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- David Diemert, MD, FRCP(C), Principal investigator, George Washington University School of Medicine & Health SciencesJulie McElrath, MD, PhD, Principal investigator, Seattle HIV Vaccine Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547245
- Sponsor's protocol ID
- G001
- Status last verified
- May 2022
- First submitted
- 27 Apr 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yan H, Peng Y, Zhang J, Peng R, Feng X, Su J, Yi H, Lu Y, Gao S, Liu J, Yang M, Liu X, Gao S, Chen Z. Rapid and highly potent humoral responses to mpox nanovaccine candidates adjuvanted by thermostable scaffolds. Vaccine. 2024 Mar 19;42(8):2072-2080. doi: 10.1016/j.vaccine.2024.02.027. Epub 2024 Feb 28.
PubMed 38423815
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03547245
- Acronym / sponsor ID
- G001
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-uninfected, healthy adults | Active comparator | Biological: eOD-GT8 60mer + AS01B/ DPBS sucrose/IM, Biological: DPBS Sucrose |
| HIV-uninfected, healthy adults - placebo | Placebo comparator | Biological: DPBS Sucrose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 IP administration;
- 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 counseling and receive HIV test result;
Key exclusion criteria (32 listed)
- 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;
- 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;
- 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 enrollment until 4 months after the last study vaccination; or lactating;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eOD-GT8 60mer + AS01B/ DPBS sucrose/IM20 μg | Biological | HIV-uninfected, healthy adults |
| eOD-GT8 60mer + AS01B/ DPBS sucrose/IM100 μg | Biological | HIV-uninfected, healthy adults |
| DPBS SucrosePlacebo | Biological | HIV-uninfected, healthy adults, HIV-uninfected, healthy adults - placebo |
Primary outcome
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).
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).
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.
2 secondary outcomes
Immunogenicity: Frequency of responses
Time frame: 16 months
Immunogenicity: Magnitude of responses
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 38423815Yan H, Peng Y, Zhang J, Peng R, Feng X, Su J, Yi H, Lu Y, Gao S, Liu J, Yang M, Liu X, Gao S, Chen Z. Rapid and highly potent humoral responses to mpox nanovaccine candidates adjuvanted by thermostable scaffolds. Vaccine. 2024 Mar 19;42(8):2072-2080. doi: 10.1016/j.vaccine.2024.02.027. Epub 2024 Feb 28.
- Related InfoLink provided by the sponsor.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Diemert, MD, FRCP(C) principal investigator
George Washington University School of Medicine & Health Sciences
Julie McElrath, MD, PhD principal investigator
Seattle HIV Vaccine Trials Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eOD-GT8 60mer + AS01B/ DPBS sucrose/IM and DPBS Sucrose in people with HIV/AIDS, run by International AIDS Vaccine Initiative at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: frequency of local and systemic reactogenicity events (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.