Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein SOSIP v8.2 763 Vaccine, Adjuvanted With MPLA Liposomes, in Healthy, HIV-Uninfected Adults

NCT05772286 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 2021-003868-27
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein SOSIP v8.2 763 Vaccine, Adjuvanted with MPLA Liposomes, in Healthy, HIV-Uninfected Adults

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Proportion of volunteers with a ≥ grade 3 solicited adverse (local or systemic)

  Measured by ≥ grade 3 solicited adverse

  from vaccination day up to 7 days post each vaccination

• Proportion of volunteers with ≥ grade 3 and/or vaccine related unsolicited adverse events

  Measured by ≥ grade 3 and/or vaccine related unsolicited adverse events

  from the day of each vaccination up to 28 days post each vaccination

• Proportion of volunteers with vaccine-related serious adverse events

  Reported as SAE

  through study completion, an average of 2 years

Secondary Outcomes (8)

• Proportion of volunteers with autologous neutralizing antibodies induced by the 763SIP8/MPLA-5 vaccine

  2 weeks after each immunization

• Serum titres of autologous neutralizing antibodies induced by the 763SIP8/MPLA-5 vaccine

  2 weeks after each immunization

• Proportion of volunteers with trimer binding antibody response induced by the 763SIP8/MPLA-5 vaccine

  2 weeks after each immunization

• Magnitude of the trimer binding antibody response induced by the 763SIP8/MPLA-5 vaccine

  2 weeks after each immunization

• Proportion of volunteers with heterologous neutralizing antibodies induced by the 763SIP8/MPLA-5 vaccine

  2 weeks after each immunization

Other Outcomes (11)

• Proportion of volunteers with and magnitude of binding antibodies to other HIV-1 Env proteins.

  2 weeks after each immunization.

• Frequency of HIV-1 Env specific B cells in peripheral blood.

  2 weeks after each immunization.

• Frequency of HIV-1 Env specific T(fh) cells in peripheral blood.

  2 weeks after each immunization.

Study Arms (1)

763SIP8/MPLA-5 vaccine

EXPERIMENTAL

Intramuscular injection of 100 μg of 763SIP8 protein adjuvanted with 500 μg MPLA liposomes will be administrated 4 times (day 0, week 8, week 24 and week 48).

Biological: 763SIP8/MPLA-5 vaccine

Interventions

763SIP8/MPLA-5 vaccine BIOLOGICAL

763SIP8/MPLA-5 vaccine at day 0, week 8, week 24 and week 48.

763SIP8/MPLA-5 vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, aged between 18 and 50 years on the day of screening.
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
• Willing and able to give written informed consent.
• Willing to undergo HIV testing, risk reduction counselling and receive HIV test results, including the possibility of vaccine-induced seropositivity (VISP).
• If female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until four months after the last vaccination.
• Highly effective contraceptive methods will include:
• oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner and sexual abstinence\*
• All female volunteers who are not heterosexually active at screening, must agree to utilize a highly effective method of contraception if they become heterosexually active, as outlined above.
• All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Visits and Procedures (Appendix 1).
• All sexually active male volunteers, regardless of reproductive potential, must be willing to use a highly effective method of contraception from the day of first vaccination until at least four months after the last vaccination to avoid exposure of partners to Investigational Medicinal Product in ejaculate and to prevent conception with female partners.
• Willing to abstain from donating blood, eggs or sperm from the day of first vaccination until at least 3 months after receiving the last dose of the vaccine and, for those who test HIV-positive due to vaccine-induced antibodies, until the anti-HIV antibody titres become undetectable.
• Body Mass Index 18 to 49 Kg/m2 at screening. \*A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. NOTE: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. 8. If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection.

You may not qualify if:

• Confirmed HIV-1 or HIV-2 infection (HIV Ag/Ab plus HIV RNA testing)
• Self-reported risk for HIV exposure or STIs prior to screening, defined as:
• 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) in the last six months;
• Engaged in sex work in the last twelve months;
• Frequent excessive daily alcohol use or frequent binge drinking, or any use of illicit drugs in the last twelve months;
• Self-reported history of newly-acquired syphilis, gonorrhoea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B in the last twelve months;
• MSM or transgender persons having had unprotected anal intercourse in the last six months with either a male partner with an unknown HIV status OR a HIV positive partner with a (presumed) detectable viral load;
• MSM or transgender persons diagnosed with a rectal STI in the last six months;
• MSM or transgender persons who have been prescribed post-exposure prohylaxis (PEP) in the last six months
• If female, pregnant or planning a pregnancy during the period of enrolment until four months after the last study vaccination; or lactating.
• Psychiatric condition that compromises the safety of the volunteers and compliance with the protocol (severe depression, psychosis, history of suicide attempts, bipolar disorder, personality disorder, severe food disorder, use of antipsychotic medication).
• History of respiratory disease requiring daily medication or any treatment of respiratory disease exacerbations in the last 5 years
• Infectious disease in the six months before screening: acute and chronic hepatitis B infection (HbsAg-positive), hepatitis C infection (anti-HCV and HCV RNA positive), treatment for chronic hepatitis C infection in the past year, or active syphilis (positive chemiluminescence immunoassay (LIAISON XL), confirmed by positive RPR).
• History of hyposplenia (anatomical or functional).
• 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 intramuscular injections and blood draws without any adverse experience, is eligible).

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• Polymun Scientific GmbH: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 16, 2023
• Study Start: July 24, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

ES (1)