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HivPhase 1NCT05983874

A Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

A Phase 1 study testing BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage in people with Hiv, run by International AIDS Vaccine Initiative at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted Read more about this study

Who is it for?
Ages 18 to 51 yearsHealthy volunteers can take part
Conditions the study is for
Hiv
What is being tested?
BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteNetherlands
Study dates
16 Apr 2024to Mar 2025
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
  • Received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
  • 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 Understanding (AOU) results, has understood the information provided and potential impact and/or risks linked to vaccine administration and participation in the trial; 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 participants born female who are engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception starting 2 weeks before the first vaccine administration and for 4 months following the last vaccine administration. Effective contraception includes:
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  • 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. 7. 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 8. All participants born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Assessments (SOA) (Appendix A) 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. For sites in the European Union (EU), participant consents to the collection and use of personal data in compliance with the General Data Protection Regulation

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, anti-tuberculosis 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 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 participant unsuitable for participation in the study
  • Reported behavior that put the participant at risk for HIV infection within 6 months prior to vaccine 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 (ie, no continuing established relationship)
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  • 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, HSV-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, lactating, or planning a pregnancy during the period of enrollment until 4 months after the last vaccine administration
  • Bleeding disorder that was diagnosed by a physician (eg, clotting factor deficiency, coagulopathy or platelet disorder that requires special precautions) Note: A participant who states that he/she has easy bruising or bleeding, but does not have a formal diagnosis and has IM injections 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 ribonucleic acid (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 vaccine administration; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccine 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 a vaccine currently, within the previous 3 months or expected participation during this study (with the exception of Protocol IAVI C101); 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 other than BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted
  • History of significant local or systemic reactogenicity to vaccines (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration)
  • Psychiatric condition that compromises safety of the participant 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 participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant 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, which is considered cured, is not an exclusion)
  • Active, serious infections requiring antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment
  • 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 PI, it is not in the best interest of the participant to participate in the trial

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • The Amsterdam University Medical Centers

    Amsterdam

Other trials in Netherlands

About this study

Official title: An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults in Good General Health Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

Read the detailed description

The study population is comprised of adults in good general health who meet all protocol inclusion criteria and do not meet any protocol exclusion criteria and who understand the study and provide written informed consent.

Up to 8 participants who received 3 doses of 300µg of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted, from the AMC clinical site in IAVI C101 (NCT04224701) will be enrolled in the study.

BG505 SOSIP.664 gp140 is a stable, soluble, cleaved HIV envelope trimer formulated in 0.55mL at 2mg/mL in 20 mM Tris, 100mM Sodium Chloride (NaCl), pH 7.5 and will be administered intramuscular (IM).

BG505 SOSIP.664 gp140 will be diluted in 20 mM Tris, 100 mM NaCl, pH 7.5 (Tris NaCl Diluent).

The 3M-052-AF is provided by AAHI. 3M-052-AF is provided in 2mL vials, with a fill volume of 0.4mL at a concentration of 50µg/mL. 3M 052 AF is a clear-to-slightly hazy, colorless liquid.

Aluminum hydroxide suspension 2% is a pyrogen free, sterilized aluminum hydroxide wet gel suspension, placed into 2 mL Type 1 vials, containing an aluminum concentration of 10 mg/mL. It appears as an opaque white gelatinous precipitate in aqueous suspension.

All administrations of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted will be given IM in a 0.5mL volume. The study product is described in detail in the Investigators Brochure.

All products slated for use in the Netherlands will have EU-compliant labels.

Conditions
Hiv
Being tested
BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage
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.

  • BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) DosageBiological

    100µg Month 0 and Month 3

Study groups in NCT05983874
Study groupRoleWhat they receive
Group 1: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) DosageExperimentalBG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum)
Receives: Biological: BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with Grade 2 or greater reactogenicity (ie, solicited AEs) from Day 0 through Day 7 after each vaccine administration

    Measured: 7 days

  2. Proportion of participants with vaccine-related unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration

    Measured: 28 days

  3. Proportion of participants with Grade 2 or greater unsolicited AEs, including safety laboratory (biochemical, hematological) parameters, from the day of each vaccine administration up to 28 days post each vaccine administration

    Measured: 28 days

  4. Proportion of participants with vaccine-related SAEs throughout the study period

    Measured: 7 months

  5. Proportion of participants in each group with potential immune-mediated diseases (pIMDs) from the day of first vaccine administration throughout the study period

    Measured: 7 months

Secondary outcomes (1)

  1. Frequency and magnitude of binding antibody responses to 2 doses of 100µg of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to adults in good general health who have received 3 doses of 300ug of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start16 Apr 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983874
Sponsor's protocol ID
IAVI C110
Status last verified
Jun 2024
First submitted
2 Aug 2023
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG505 SOSIP.664 gp140 Vaccine, Adjuvanted (3M-052 AF plus alum) Dosage in people with Hiv, run by International AIDS Vaccine Initiative at 1 site in Netherlands.

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 15 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Results are not available in the source record.

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?

Proportion of participants with Grade 2 or greater reactogenicity (ie, solicited AEs) from Day 0 through Day 7 after each vaccine administration (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 NCT05983874.

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 11 Jun 2024.

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