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HIV InfectionsPhase 1NCT03699241

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV Envelope Protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in Healthy, HIV-1 Uninfected Adults

A Phase 1 study testing BG505 SOSIP.664 gp140, adjuvanted in people with HIV Infections, run by International AIDS Vaccine Initiative at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected 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 Infections
What is being tested?
BG505 SOSIP.664 gp140, adjuvanted
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
3 sitesin 2 countries
Study dates
3 Dec 2018to 11 Jul 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 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 vaccination
  • 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 counselling and receive HIV test results
  • All volunteers born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for 4 months following investigational product 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
  • All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures (Appendix A and B)
  • 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 first vaccination until at least 4 months after the last vaccination to avoid exposure of partners to investigational product in ejaculate and to prevent conception with female partners
  • 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

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 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 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 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 enrolment until 4 months after the last study vaccination; or lactating
  • Bleeding disorder that was diagnosed by a physician (e.g., 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 IM injections and blood draws without any adverse experience, is eligible)
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  • Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (for US sites: HCV Ab positive and HCV RNA positive, for African site: HCV Ab positive only) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA); active tuberculosis (for African site only)
  • History of splenectomy
  • Any of the following abnormal laboratory parameters listed below:
  • Hematology
  • Absolute Neutrophil Count (ANC) - all volunteers: ≤1,000/mm3
  • Absolute Lymphocyte Count (ALC) - all volunteers: ≤650/mm3
  • Hemoglobin - African volunteers: <9.5 g/dl in females; <11.0 g/dl in males
  • Hemoglobin - US volunteers: <10.5 g/dl in females; <11.0 g/dl in males
  • Platelets - African volunteers: <100,000 cells/mm3
  • Platelets - US volunteers: <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)
  • 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)
  • 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 study not requiring any blood or tissue sample collection is not an exclusion
  • Prior receipt of another investigational HIV vaccine candidate or HIV monoclonal antibody (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 participant who has had a seizure in the last 3 years prior to screening is excluded. (Not excluded: a participant 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 enrolment
  • Body mass index (BMI) ≥35
  • Body weight <110 pounds (55 kg); for US sites only
  • 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

  • MGH

    Boston, Massachusetts, 02114

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

Kenya1 site

  • Kenya AIDS Vaccine Initiative

    Nairobi

Other trials in Kenya

About this study

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers.

Read the detailed description

This a phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and immunogenicity of BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in up to 60 healthy adult HIV-uninfected volunteers. BG505 SOSIP.664 gp140 is a stable, soluble, cleaved HIV envelope trimer 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.664 gp140, 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.664 gp140, adjuvantedBiological

    Dosage of 30ug, Intramuscular administration

  • BG505 SOSIP.664 gp140, adjuvantedBiological

    Dosage of 100ug, Intramuscular administration

  • BG505 SOSIP.664 gp140, adjuvantedBiological

    Dosage of 300ug, Intramuscular administration

  • PlaceboBiological

    Tris-NaCl Diluent

Study groups in NCT03699241
Study groupRoleWhat they receive
Group 1Placebo comparatorHIV-Uninfected participants
Receives: Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo
Group 2Placebo comparatorHIV-Uninfected participants
Receives: Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo
Group 3Placebo comparatorHIV-Uninfected participants
Receives: Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo
Group 4Placebo comparatorHIV-Uninfected participants
Receives: Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo
Group 5Placebo comparatorHIV-Uninfected participants
Receives: Biological: BG505 SOSIP.664 gp140, adjuvanted; Biological: Placebo

What is being measured

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

  1. Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination

    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 post-vaccination

  2. Proportion of volunteers with moderate or greater and/or vaccine related unsolicited adverse events (AEs), including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination

    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: 28 days post-vaccination

  3. Proportion of volunteers with vaccine-related serious adverse events (SAEs) throughout the study period

    To evaluate the safety and tolerability of the study regimens based on the proportion of volunteers with vaccine-related serious adverse events including safety laboratory as assessed using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v2.1).

    Measured: 18 months

  4. Proportion of volunteers in each group with potential immune-mediated diseases (pIMD) from the day of injection throughout the study period

    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: 18 months

Secondary outcomes (5)

  1. To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

    Proportion of volunteers with neutralizing antibodies against autologous BG505 SOSIP.664 gp140 Vaccine, Adjuvanted

    Measured: 20 months

  2. To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

    Proportion of volunteers with and magnitude of trimer binding antibodies to BG505 SOSIP.664 gp140 Vaccine, Adjuvanted

    Measured: 20 months

  3. To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

    Proportion of volunteers with neutralizing antibodies against additional viral strains (e.g., Tier 1a/b, Tier 2)

    Measured: 20 months

  4. To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

    Proportion of volunteers with and magnitude of binding antibodies to HIV Env

    Measured: 20 months

  5. To assess immune responses elicited by the different BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, doses:

    Proportion of volunteers with HIV Env specific B and T-cell responses

    Measured: 20 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 Oct 2018
  2. Study start3 Dec 2018
  3. Primary completion21 Mar 2023
  4. Study completion11 Jul 2023

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699241
Sponsor's protocol ID
IAVI W001
Status last verified
Dec 2023
First submitted
3 Oct 2018
Last updated
14 Dec 2023
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, 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 10 inclusion and 36 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 14 Dec 2023. 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, Kenya. 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?

Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7-day follow-up period after each vaccination (time frame: 7 days post-vaccination). The study lists 4 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 NCT03699241.

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 14 Dec 2023.

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Clinical Trial NCT03699241 | AzTrials