HIV InfectionsPhase 1NCT04224701
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
A Phase 1 study testing BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted in people with HIV Infections, run by International AIDS Vaccine Initiative at 3 sites in 2 countries.
Trial summary
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2020to 2 Aug 2023
- 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 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 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 51 birthday on the day 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 or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to IP administration 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 results;
- All volunteers born female who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception at the time of the first IP administration and for 4 months following the last IP administration.
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- 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 as outlined above;
- All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures
- 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 the first IP administration until at least 4 months after the last IP administration;
- 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.
- For sites in the European Union (EU), consent to the collection and use of personal data in compliance with the General Data Protection Regulation (GDPR)
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 or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months;
- 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 behavior which put the volunteer at risk for HIV infection within 6 months prior to IP administration, 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
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- 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, HSV-2, chlamydia, pelvic inflammatory disease (PID), 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 (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions)
- Infectious disease diagnosis: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA positive or interferon-alfa treatment for hepatitis C infection in the past year or interferon-alfa-free treatment for hepatitis C infection completed in the past 6 months), or active syphilis (screening and confirmatory tests);
- History of splenectomy;
- Any of the following abnormal laboratory parameters listed below:
- Hematology
- Hemoglobin - <10.5 g/dl or <6.5 mmol/L in females; <11.0 g/dl or <6.8 mmol/L in males
- Absolute Neutrophil Count (ANC) - ≤1,000/mm3 or < 1.0 x 109 cells/L
- Absolute Lymphocyte Count (ALC) - ≤650/mm3 or < 0.65 x 109 cells/L
- Platelets - <125,000 cells/mm3 or < 125 x 109 cells/L
- Chemistry
- Creatinine - >1.1 x upper limit of normal (ULN)
- AST - >1.25 x ULN
- ALT - >1.25 x ULN
- Urinalysis
- Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 1+ or more
- Blood = 2+ or more (not due to menses)
- Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after IP administration; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after IP administration. (Exception is live attenuated influenza vaccine within 14 days.);
- Receipt of blood transfusion or blood-derived products within the previous 3 months;
- 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 blood or tissue sample collection is not an exclusion;
- Prior receipt of any investigational HIV vaccine candidate or HIV monoclonal antibody Note: receipt of placebo in a previous HIV vaccine trial or monoclonal antibody trial will not exclude a volunteer from participation if documentation is available and the Medical Monitor gives approval;
- History of significant 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, 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 is excluded. (Not excluded: a volunteer with a history of seizures who has neither required medications nor had a seizure for 3 years);
- History of malignancy in the past 5 years (prior to screening) or ongoing malignancy (a history of completely excised malignancy that is considered cured is not an exclusion);
- Active, serious infections requiring antibiotic, antiviral or antifungal therapy within 30 days prior to enrolment;
- Body mass index (BMI) ≥35;
- Body weight <110 pounds (50 kg);
- Prior daily use of NSAID/aspirin that cannot be held for 5 days prior to the leukapheresis procedure (if required by the study site);
- 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
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Rockefeller University
New York, New York, 10065
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
Read the detailed description
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. BG505 SOSIP.GT1.1 is a soluable, cleavage-competent, trimeric HIV-1 envelope glycoprotein gp140 formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100 mM naCL, pH 7.5 and will be administered IM.
- Conditions
- HIV Infections
- Being tested
- BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG505 SOSIP GT1.1 gp140 Vaccine, AdjuvantedBiological
30 µg
BG505 SOSIP GT1.1 gp140 Vaccine, AdjuvantedBiological
300 µg
PlaceboBiological
Tris NaCl Diluent
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product, 30 µg/ Placebo | Experimental | 30 µg IM, months 0, 2 and 6 Receives: Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted; Biological: Placebo |
| Investigational Product, 300 µg/ Placebo | Experimental | 300 µg IM, months 0, 2 and 6 Receives: Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - reactogenicity
Proportion of volunteers with Grade 2 or greater reactogenicity (i.e., solicited adverse events) from Day 0 through Day 7 after each investigational product (IP) administration
Measured: 7 Days
Safety - IP related unsolicited adverse events
Proportion of volunteers with IP-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Measured: 28 days
Safety - Grade 2 or greater unsolicited AEs
Proportion of volunteers with Grade 2 or greater unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Measured: 28 days
Safety - IP related SAEs
Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period
Measured: 18 Months
Safety - pIMDs
Proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) from the day of first IP administration throughout the study period
Measured: 18 Months
Secondary outcomes (2)
Immunogenicity - Frequency Ab responses
Frequency of binding antibody responses to GT1.1 trimer after the first, second, and/or third IP administrations compared to baseline
Measured: 6 Months
Immunogenicity - Magnitude Ab responses
Magnitude of binding antibody responses to GT1.1 trimer after the first, second, and/or third IP administrations compared to baseline
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Aug 2020
- Primary completion5 Jul 2023
- Study completion2 Aug 2023
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 InfectionsStudies 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, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline, Rockefeller University, George Washington University, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Marina Caskey, MD, Principal investigator, Rockefeller UniversityGodelieve de Bree, MD, PhD, Principal investigator, Amsterdam UMC, location VUmcDavid Joseph Diemert, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224701
- Sponsor's protocol ID
- IAVI C101
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2019
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38628675
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
- ClinicalTrials.gov ID
- NCT04224701
- Acronym / sponsor ID
- IAVI C101
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- GlaxoSmithKline, Rockefeller University, George Washington University, Amsterdam UMC, location VUmc
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 13 Jan 2020 (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 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
Detailed description
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers. BG505 SOSIP.GT1.1 is a soluable, cleavage-competent, trimeric HIV-1 envelope glycoprotein gp140 formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100 mM naCL, pH 7.5 and will be administered IM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product, 30 µg/ Placebo | Experimental | Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted, Biological: Placebo30 µg IM, months 0, 2 and 6 |
| Investigational Product, 300 µg/ Placebo | Experimental | Biological: BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted, Biological: Placebo300 µg IM, months 0, 2 and 6 |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adults 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 51 birthday on the day 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 or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to IP administration 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 results;
Key exclusion criteria (40 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 or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months;
- 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 behavior which put the volunteer at risk for HIV infection within 6 months prior to IP administration, as defined by:
- If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last IP administration; 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 |
|---|---|---|
| BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted30 µg | Biological | Investigational Product, 30 µg/ Placebo |
| BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted300 µg | Biological | Investigational Product, 300 µg/ Placebo |
| PlaceboTris NaCl Diluent | Biological | Investigational Product, 30 µg/ Placebo, Investigational Product, 300 µg/ Placebo |
Primary outcome
Safety - reactogenicity
Time frame: 7 Days
Proportion of volunteers with Grade 2 or greater reactogenicity (i.e., solicited adverse events) from Day 0 through Day 7 after each investigational product (IP) administration
Safety - IP related unsolicited adverse events
Time frame: 28 days
Proportion of volunteers with IP-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Safety - Grade 2 or greater unsolicited AEs
Time frame: 28 days
Proportion of volunteers with Grade 2 or greater unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, from the day of each IP administration up to 28 days post each IP administration
Safety - IP related SAEs
Time frame: 18 Months
Proportion of volunteers with IP-related serious adverse events (SAEs) throughout the study period
Safety - pIMDs
Time frame: 18 Months
Proportion of volunteers in each group with potential immune-mediated diseases (pIMDs) from the day of first IP administration throughout the study period
2 secondary outcomes
Immunogenicity - Frequency Ab responses
Time frame: 6 Months
Immunogenicity - Magnitude Ab responses
Time frame: 6 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 5 Dec 2024.
- Derived from this study: PubMed 38628675Libera 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.
- Related InfoLink provided by the sponsor.
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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.
Marina Caskey, MD principal investigator
Rockefeller University
Godelieve de Bree, MD, PhD principal investigator
Amsterdam UMC, location VUmc
David Joseph Diemert, MD principal investigator
George Washington University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted in people with HIV Infections, run by International AIDS Vaccine Initiative at 3 sites in 2 countries.
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 11 inclusion and 40 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Netherlands. 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. 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 - reactogenicity (time frame: 7 Days). The study lists 5 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 NCT04224701, 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 5 Dec 2024.